By: Dane Christiansen and Kira Flaherty, Washington Representatives

April 24, 2026

At the start of April, the administration released its Fiscal Year (FY) 2027 Budget Request to Congress. The nonbinding annual document provides a blueprint to lawmakers on administration priorities and traditionally starts the annual appropriations process. This year though, the House and Senate were both well on their way to crafting the FY 2027 spending bills before the administration even provided its requested budget.

The Trump administration has systematically called on Congress to provide deep funding cuts and consolidation for medical research and public health programs. Congress has routinely resisted these proposals (including for FY 2026) and opted to maintain the status quo, even providing modest increases for research while level-funding for public health. The FY 2027 request repeats these calls, but in a notably toned-down fashion with smaller cuts for NIH and more modest reorganization proposals.

The FY 2027 budget request to Congress includes:

• $111.1 billion in discretionary funding for HHS, a proposed decrease of roughly $15.8 billion from FY 2026.
  • $7.23 billion in total funding for the Food and Drug Administration (FDA), a proposed increase of $232 million over FY 2026, comprised of $3.3 billion in discretionary funding (a proposed decrease of $48 million) and $3.92 billion in user fees (a proposed increase of $280 million).
  • $9.14 billion for the Indian Health Service (IHS), a proposed increase of $958 million over FY 2026.
  • $5.2 billion for the Centers for Disease Control and Prevention (CDC), not including programs moved to AHA, a proposed reduction of $484 million over FY 2026.
  • $41.47 billion for the National Institutes of Health (NIH), a proposed decrease of $4.8 billion over FY 2026.
    • Capping indirect costs rates at 15%.
    • The CTSA program only receives a 7.5% proposed cut, less that the overall 12.5% cut proposed for NIH.
  • $945 million for the Advanced Research Projects Agency for Health (ARPA-H), a proposed decrease of $555 million from FY 2026.
  • $14.67 billion for Administration for a Healthy America (AHA), a proposed reduction of $4.98 billion from FY 2026. While AHA was not created by FY 2026, the budget request numbers appear derived from taking the funding lines that would normally exist (SAMHSA, HRSA, AHRQ, parts of CDC), and comparing them to their traditional function and funding from the prior year.
• $76.5 billion in discretionary funding for Ed, a proposed decrease of $2.3 billion from FY 2026.

Lawmakers seem poised, once again, to maintain federal agencies and possibly provide funding increases through the FY 2027 process. Grassroots advocacy remains critical though to educate Senators and Representatives about ongoing opportunities and challenges (such as the problems with multi-year funding) to justify additional research funding. Congress will need to make tough spending decisions and they are making key decisions now, ahead of campaign season for the November elections. 

The lack of final FY 2026 appropriations for DHS, delayed the release of the President’s annual budget request to Congress, which would traditionally serve as the start of the FY 2027 appropriations process. Both the House and Senate though have begun moving forward with crafting their annual spending bills without administration input. The House has provided the opportunity to submit written testimony on Labor-HHS-Educaton (L-HHS) priorities by April 16th with a current goal of marking up an FY 27 L-HHS spending bill in mid-June. The Senate is following the House’s lead and has announced request deadlines around then end of April with markups likely taking place later in June.

Congress is also increasingly concerned over leadership at the NIH and the ability to commit grant funding and drive research portfolios forward. The NIH Director was summoned before House appropriators to discuss his dual role as Acting CDC Director, to answer questions about the lack of installed Institute and Center Directors, and to hear concerns about the slow pace of grant review. It is unclear what next steps Congress might take as reports about disruptions in funding from the CR and the inability to efficiently complete grant reviews swirl around the agency.

CCTS is actively engaged in the FY 2027 appropriations process and once again supporting community funding requests while leading on efforts to advance CTSAs, IDeA, and other programs. CCTS will be asking Congress to:

• Please provide NIH with at least $51.3 billion, roughly a 8.5% increase over FY 2026.
• Please provide the National Center for Advancing Translational Science (NCATS) at NIH with at least a proportional 8.5% funding increase for FY 2026.
• Please provide at least $660 million in dedicated line-item funding for the flagship Clinical and Translational Science Awards (CTSA) program, an increase of $30.5 million over FY 2026
• Please provide continued funding increases for NIGMS and the IDeA Program.
• Please provide the Centers for Disease Control and Prevention (CDC) with at least $11.58 billion, an estimated increase of $2.37 billion over FY 2026.
• Please provide the Agency for Healthcare Research and Quality (AHRQ) with at least $500 million, an estimated increase of roughly $150 million over FY 2026.

By: Dane Christiansen and Kira Flaherty, Washington Representatives

February 20, 2026

February concluded on Capitol Hill with the President providing the annual State of the Union address to Congress. There is a great deal of interest in what the White House’s new priorities and proposals will be for 2026, particularly after Congress rebuked last year’s requests from the administration to de-fund research and reorganize public health agencies.

At the end of January, Congress completed work on nearly all the outstanding FY 2026 appropriations bills, including passing the Labor-HHS-Education (L-HHS) measure and the Defense (DoD) measure. The L-HHS bill maintained the status quo across agencies while advancing policy riders to promote non-interference in research and enacting patient care bills that had been languishing while the DoD bill restored funding to the Congressionally Directed Medical Research Program. Lawmakers could not reach agreement on the annual bill funding the Department of Homeland Security (DHS) due to disagreements on oversight of Immigration and Custom Enforcement. Ongoing deliberations to resolve the deadlock (DHS remains “shutdown” at the moment) have waylaid planned work on Senate negotiations to extend expiring healthcare premium tax credits and delayed the release of the administration’s budget request to Congress for FY 2027 until mid-March.

Congress continues to express frustration with the administration and the National Institutes of Health (NIH) over the lack of permanent leadership for most Institutes and Centers. Shortly after these concerns were officially voiced, the administration announced that the NIAMS Director would not be returning, creating another vacancy, and that the NIH Director would start serving as the CDC Administrator too. While single officials sometimes ran multiple agencies during the previous Trump presidential term, the lack of geographic proximity between NIH and CDC allowing with differing missions could prove complicated.

It is important to note though that despite the delayed budget request and late completion of the FY 2026 spending bills Congress has already started its work to craft the Fy 2027 appropriations bills. Advocacy will be needed to secure funding increases and policy guidance for key programs. It is an election year and in addition to having legislators work quickly to finish initial drafts of key bills before campaign season starts this summer, legislators will also be uniquely tuned in to the needs and requests of constituents. 

By Dane Christiansen and Kira Flaherty, Washington Representatives

January 23rd, 2026

The House passed the final, remaining Fiscal Year (FY) 2026 appropriations bills, including the bills for Labor-HHS-Education (L-HHS) and the Department of Defense (DoD). The Senate is expected to take the outstanding spending bills up before the current Continuing Resolution (CR) funding the federal government expires on January 30th. Thus far, all spending bills have been crafted and advanced in a strong bipartisan fashion, and if lawmakers can complete the process, they will enact meaningful funding for federal agencies along with strong policy riders intended to preserve the integrity of the research process.

Of particular interest to the Coalition for Clinical and Translational Science, the final FY 2026 spending bills provide:

DoD

• Restoration of full funding (about $1.2 billion annually) for the Department of Defense Congressionally Directed Medical Research Program, including restored funds and adopted eligible condition lists for the Peer-Reviewed Medical Research program and the Peer-Reviewed Cancer Research Program.

L-HHS

• A modest $400 million increase for the National Institutes of Health and medical research (for a budget that is roughly $47 billion annually).

• A modest $100 million cut for the Centers for Disease Control and Prevention and public health (for a budget that is roughly $9 billion annually).

• Maintenance of funding for the Health Resources and Services Administration (HRSA), the Agency for Healthcare Research and Quality (AHRQ), and other public health programs with clear guidance that the administration cannot to take any reorganization action.

• Continued inclusion of the CTSA line-item and $629.56 million for CTSAs along with adoption of all report language from the House and Senate, including Senate instructions regarding ongoing support for CTSA hubs. N3C is also provided with a $4 million funding increase.

• A $20 million funding increase for the Institutional Development Awards program.

• New policy riders seeking to preserve the integrity of the medical research process by placing restrictions on changes the administration would like to make that could jeopardize ongoing and emerging research projects, by protecting the current indirect cost policy, placing guardrails on the use of multi-year funding, and seeking a plan from the administration to ensure permanent leadership across NIH Institutes and Centers.

Once the FY 2026 appropriations process is completed, Congress is expected to begin work on federal funding for FY 2027 and additional advocacy will be needed to ensure further progress on key priorities

Clinical Research Forum’s annual competition highlights major advances resulting from the nation’s investment in research

Media Contact: Andrea Van Hook, avanhook@clinicalresearchforum.org

Washington, D.C. – January 20, 2026 – The Clinical Research (CR) Forum will honor ten
outstanding clinical research studies at the 2026 Top Ten Clinical Research Achievement
Awards in Washington, D.C. on May 11, 2026.

These 10 award-winning studies exemplify major advances resulting from the nation’s investment in research to benefit the health and welfare of its citizens. They reflect the influential work being conducted by investigators at nearly 60 research institutions and hospitals across the United States and at partner institutions from around the world. All nominated studies were published in peer-reviewed journals during 2025.

At the awards ceremony on May 11, three of the Top 10 studies will receive additional
recognition and cash prizes:

• The Herbert Pardes MD Clinical Research Excellence Award, named in memory of CR Forum board member, Dr. Herbert Pardes, for his profound impact on clinical research and academic medicine; this award, which comes with a $7,500 cash prize, is for the research study that best shows a high degree of innovation and creativity, advances in science, and has an impact upon human disease.
  · The Distinguished Clinical Research Achievement Awards, presented to the top two studies that show creativity, innovation, or a novel approach that demonstrates an
  immediate impact on the health and well-being of patients. Each study will receive a
  $5,000 cash prize.

The Top 10 were selected based on the degree of innovation and novelty involved in the
advancement of science, contribution to the understanding of human disease, and potential impact upon the diagnosis, prevention, and/or treatment of disease. Several of the Top 10 were supported by Clinical and Translational Science Awards (CTSA) Programs, a national initiative run by the National Institutes of Health (NIH) that aims to accelerate the translation of research discoveries into improved patient care by supporting a network of medical institutions focused on advancing clinical and translational science, effectively bringing more treatments to patients faster through collaborative research efforts across laboratories, clinics, and communities.

2026 Top 10 Clinical Research Achievement Awardees (in alphabetical order by title):

AI-guided precision parenteral nutrition for neonatal intensive care units – Nima Aghaeepour, B.Sc., PhD, Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University

Blinatumomab in Standard-Risk B-Cell Acute Lymphoblastic Leukemia in Children – Mignon Loh, MD, Professor of Pediatrics, University of Washington; Director, Ben Towne Center for Childhood Cancer Research, Seattle Children’s Hospital; Head, Division of Pediatric Hematology, Oncology, Bone Marrow Transplant and Cellular Therapy, Seattle Children's Hospital

Gene Therapy for Patients with Danon Disease – Barry H. Greenberg, MD, FHFSA, Cardiologist and Distinguished Professor of Medicine, University of California San Diego

Long COVID associated with SARS-CoV-2 reinfection among children and adolescents in the Omicron era (RECOVER-EHR) – Yong Chen, PhD, Professor of Biostatistics, University of Pennsylvania

Loss of Subsidized Drug Coverage and Mortality among Medicare Beneficiaries – Eric T. Roberts, PhD, Associate Professor of Medicine, University of Pennsylvania

Permethrin-Treated Baby Wraps for the Prevention of Malaria – Ross M. Boyce, MD, MSc, Associate Professor of Medicine, University of North Carolina at Chapel Hill

SARS-CoV-2 mRNA vaccines sensitize tumors to immune checkpoint blockade – Adam Grippin, MD, PhD, Radiation Oncology Resident, University of Texas, and Elias Sayour, MD, PhD, Professor of Neurosurgery and Pediatrics, University of Florida

Spinal cord stimulation in motoneuron diseases – Genis Prat-Ortega, PhD, Assistant Professor of Neurosurgery, University of Pittsburgh

Targeting dormant tumor cells to prevent breast cancer recurrence – Angela DeMichele, MD, MSCE, FASCO, Mariann T. and Robert J. MacDonald Professor in Breast Cancer, and Lewis Chodosh, MD, PhD, Professor of Medicine and Chair of the Department of Cancer Biology, University of Pennsylvania

Treatment of an Infant with Severe Neonatal-Onset Carbamoyl Phosphate Synthetase 1 Deficiency with a Personalized Gene-Editing Therapy – Rebecca Ahrens-Nicklas, MD, PhD, Assistant Professor of Pediatrics, Children’s Hospital of Philadelphia and University of Pennsylvania

In addition to the Top 10, the Clinical Research Forum also recognizes an additional 10 studies as finalists:

A neoantigen vaccine generates antitumour immunity in renal cell carcinoma  - David A. Braun, MD, PhD, Assistant Professor of Medicine (Medical Oncology), Yale School of Medicine

A phase 3, randomized, placebo-controlled trial of a Janus kinase inhibitor to treat giant cell arteritis - Peter A. Merkel, MD, MPH, Professor of Medicine and Epidemiology; Chief, Division of Rheumatology, University of Pennsylvania

Acuity Prediction in Intensive Care Unit-Mamba (APRICOT-M) - Azra Bihorac, MD, MS FCCN, FASN, Senior Associate Dean of Research and Professor of Medicine, University of Florida College of Medicine

Dietary Patterns, Sodium Reduction, and Blood Pressure in Type 2 Diabetes: The DASH4D Randomized Clinical Trial -  Scott Pilla, MD, MHS, Assistant Professor of Medicine, Johns Hopkins University School of Medicine

Impact of the MISSION Act on Quality and Outcomes of Interventional Cardiology and Cardiac Surgery among Veterans -Peter W. Groeneveld, MD, MS, Professor of Medicine, University of Pennsylvania

INSPIRE Improving Empiric Antibiotic Selection for Patients Hospitalized With Abdominal & Skin/Soft Tissue Infections  - Shruti Gohil, MD, Assistant Professor and Associate Medical Director of Epidemiology & Infection Prevention, University of California, Irvine

Microglial mechanisms drive amyloid-β clearance in immunized patients with Alzheimer's disease  - David M. Gate, PhD, Assistant Professor of Neurology, Northwestern University Feinberg School of Medicine

Phase I Trial of huCART19-IL18 Cells in Patients with Relapsed or Refractory CD19+ Cancers - Jakub Svoboda, MD, Associate Professor of Medicine, University of Pennsylvania

Prademagene zamikeracel for recessive dystrophic epidermolysis bullosa wounds (VIITAL) - Jean Y. Tang, MD, PhD, Professor of Dermatology, Stanford University

Type 2 Diabetes Pharmacotherapy De-Escalation Through AI-Enabled Lifestyle Modifications  - Kevin Pantalone, DO, Professor of Medicine, Cleveland Clinic

About the Top Ten Clinical Research Achievement Awards
Recognizing the need to celebrate our nation's clinical research accomplishments that involve
both innovation and impact on human disease, the Clinical Research Forum conducts an annual
competition to determine the ten outstanding research accomplishments in the United States.
These major research advances represent a portion of the annual return on the nation's
investment in the health and future welfare of its citizens.

About the Clinical Research Forum and the Clinical Research Foundation
The mission of the Clinical Research Forum is to provide leadership to the national and clinical
translational research enterprise and promote understanding and support for clinical research
and its impact on health and healthcare. For more information,
visit www.clinicalresearchforum.org.

The Clinical Research Foundation is the charitable arm of the Clinical Research Forum. As a
501(c)(3), gifts to the foundation support the Top Ten Clinical Research Achievement Awards
and are tax deductible.

Event Details
The Top 10 Clinical Research Achievement Awards Ceremony is May 11, 2026 in Washington, D.C. Please visit our website to learn more.

By: Dane Christiansen and Kira Flaherty, Washington Representatives

December 26, 2025

The 119th Congress adjourned in mid-December, concluding its first session. Lawmakers were working to address rising healthcare costs, but after voting down competing partisan proposals in the Senate, no further action was taken. With members of the House under extreme pressure from constituents, a coalition of Democratic and Republican lawmakers sought to extend expiring premium tax credits, ultimately though, the House opted to pass a partisan (and hastily assembled) Republican health plan instead. Before adjourning, the Senate indicated it had no intention of considering the House-passed bill.

With a lack of progress on healthcare costs, the Senate considered and passed the Fiscal Year (FY) 2026 National Defense Authorization Act (NDAA). Notably, the NDAA authorizes defense funding, continues to support activities in Ukraine, and tightens the congressional reins over the DoD following congressional scrutiny of military activity in the Caribbean. The Senate also confirmed some outstanding nominees before half-heartedly attempting to pass a five-bill minibus package comprised of some FY 2026 appropriations bills. The package that was only briefly considered included the annual funding bills for Defense, Labor-HHS-Education, Commerce-Justice-Science, and Transportation-Housing-Urban Development.

Congress will reconvene on January 5th for its second session, and lawmakers will have until January 30th to pass the nine outstanding annual spending bills. Appropriators continue to express their belief that they are very close to concluding the FY 2026 funding cycle and will move on to FY 2027 when the President’s next Budget Request is released in early February. The debate over healthcare costs and health policy may continue over the entire year as legislators balance a new focus on “affordability” with ongoing efforts to reach consensus on PBM reform and 340B reform while passing a number of overdue patient care bills.

We encourage the community to actively participate in advocacy activities focused on research funding and government non-interference in research in 2026 and in the meantime we wish everyone a Happy New Year.

By: Dane Christiansen and Kira Flaherty, Washington Representatives

November 21, 2025

The November 4^th state and local elections across the country sent political shockwaves that quickly reached Capitol Hill. Not long after the results were known, Congress passed a funding package to reopen the federal government after the longest shutdown in U.S. history. While not included in the package, a December vote was promised in the Senate on extending healthcare premium tax credits originally enacted through the Affordable Care Act. The measure is not expected to pass the Republican controlled Senate and House (nor be signed by the President), but healthcare costs and access are once again the focus of policymakers and “affordability” is the new mantra in Washington.

The spending package passed by Congress included a three-bill “minibus” of annual Fiscal Year (FY) 2026 appropriations bills (namely MilCon-VA, Ag-FDA, and Legislative branch) and a Continuing Appropriations Resolution (CR) until January 30^th to buy time to finish the nine outstanding appropriations bills. The enacted spending bills largely maintained business as usual for respective federal agencies and provided:

CR

• Extends current FY 2025 funding for programs lacking an enacted appropriations bill until January 30^th.
• Provides backpay to federal employees impacted by the shutdown, reverses the reduction in force that occurred, and prevents further furloughs during the CR.
• Extends telehealth flexibilities and related Medicare items.
• Does not address the issues of ACA premium tax credits, but the Senate intends to vote on this issue in December.

MilCon-VA

• $945 million for the VA Medical and Prosthetic Research Program, an increase of $2 million over FY 2025, and the previous House and Senate proposals.

Ag-FDA

• $7.07 billion in total funding for the Food and Drug Administration (FDA), an increase of $242.95 million over FY 2025. Overall funding provides $3.43 billion in discretionary funding for FDA, a decrease of $100 million from FY 2025 and $3.64 billion in user fees, an increase of $342.95 million over FY 2025.
  • $1.56 billion in prescription drug user fees, an increase of $133.94 million over FY 2025.
  • $478.17 million in medical device user fees, an increase of $115.79 million over FY 2025.
  • $670.9 million in generic drug user fees, an increase of $57.36 million over FY 2025.
  • $55.84 million in biosimilars user fees, an increase of $24.73 million over FY 2025.
  • $712 million in tobacco product user fees, level funded from FY 2025.

By: Dane Christiansen and Kira Flaherty, Washington Representatives

September 25, 2025

After returning from the August congressional recess, the House moved forward with a markup of its Fiscal Year (FY) 2026 Labor-HHS-Education (L-HHS) Bil. While the bill took a more muted approach than the Senate (which aggressively pushed back on several administration proposals), it similarly did not reorganize NIH, create a new public health agency nor reduce funding for HHS by 20%. Rather, the bill increased NIH funding by $100 million and cut HHS by 6% through the elimination of funding for programs that are viewed as progressive. In fact, the House increased a number of accounts that it prioritizes, and where these increases land and their size will form the basis of upcoming negotiations with the House. These House increases included a $25 million increase for the Institutional Development Awards (IDeA). A general summary is listed below and CCTS will provide further guidance on fall advocacy at the appropriate time.

FY26 House L-HHS Bill.

• $108.06 billion in discretionary funding for HHS, a proposed decrease of $6.9 billion below FY 2025 and $8.8 billion less than the Senate proposal.

• $7.12 billion for the Health Resources and Services Administration (HRSA), a proposed decrease of $879.1 million below FY 2025 and $1.72 billion less than the Senate proposal.

   

• $7.48 billion for the Centers for Disease Control and Prevention (CDC), a proposed decrease of $1.74 billion below FY 2025 and $1.67 billion less than the Senate proposal.

   

• $46.9 billion for NIH, a proposed increase of $99 million over FY 2025 and $300 million less than the Senate proposal.

   

• $945 million for the Advanced Research Projects Agency for Health (ARPA-H), a proposed decrease of $555 million below FY 2025 and the Senate proposal.

   

• $7.08 billion for the Substance Abuse and Mental Health Services Administration (SAMHSA), a proposed decrease of $298.45 million below FY 2025 and $350 million less than the Senate proposal.

   

• $0 from the AHRQ, a proposed decrease of $369 million below FY 2025 and $345.4 million less than the Senate proposal.

   

• $607.19 million for the Office of the HHS Secretary, a proposed decrease of $103.77 million below FY 2025 and $70.75 million less than the Senate Proposal.

• $100 million for the new MAHA initiative, a proposed increase of $100 million over FY 2025 and the Senate proposal.

NIH Details

• $3.26 billion for the National Institute of General Medical Sciences (NIGMS), a proposed increase of $21 million over FY 2025 and over the Senate Proposal.
  • $25 million funding increase for the IDeA program and language regarding CTSA collaboration.
• $544.40 million for the National Institute on Minority Health and Health Disparities (NIMHD), a proposed increase of $10 million over FY 2025 and $10 million over the Senate proposal.
• $928.32 million for the National Center for Advancing Translational Sciences (NCATS), a proposal level with FY 2025 and level $10 million less than the Seante proposal.
  • The CTSA line item is removed to provide a new line item of $75 million for N3C support. The Senate maintains the line-item and level funds CTSAs.
• $2.44 billion for the Office of the Director, a proposed decrease of $164 million below FY 2025, including $672.4 million for the Common Fund, a proposal level with FY 2025.
• Policy riders on indirect costs that represent a middle ground between the administration and Senate proposals, but likely intended to serve as a place holder while final negotiations continue on a new policy.

Introduction

The Clinical and Translational Science Awards (CTSA) program serves as the catalyst of the National Institutes of Health's efforts to accelerate the translation of scientific discoveries into improved patient care and population health outcomes.

This federal investment supports an unparalleled breadth of critical functions spanning the entire translational research spectrum, from basic laboratory discoveries through clinical trials to community implementation and dissemination of evidence-based interventions. Unlike any other NIH program, the CTSA initiative provides comprehensive infrastructure support for research design and biostatistics, regulatory knowledge and support, community engagement, workforce development, and collaborative networks that are essential for transforming scientific breakthroughs into real-world health solutions. The program's transformative impact extends far beyond traditional research powerhouses, enabling institutions across the nation—including those in underserved regions and emerging research environments—to build robust translational research capabilities and contribute meaningfully to the national mission of improving health outcomes.

Without the CTSA program's unique and comprehensive approach, the leading US research institutions would lack the specialized resources, expertise, and collaborative networks necessary to bridge the critical gap between scientific discovery and clinical application, ultimately limiting the nation's capacity to translate research investments into tangible health benefits for patients and communities.

Clinical Research Forum has growing concerns about the health of CTSAs, due to the Administration’s recent activities which have resulted in confusion, grant delays, and funding cuts. To that end, Clinical Research Forum conducted a survey of all Clinical and Translational Science Awards (CTSA) grantees in August 2025. This survey reveals significant disruptions to CTSA research activities, with widespread funding delays, budget reductions, and operational challenges affecting research institutions nationwide. The survey of 41 respondents (out of 60 funded programs) highlights systemic issues that have compromised research continuity and institutional planning.

Threats to Research Continuity and Innovation

The survey data reveals a research ecosystem under significant strain, with funding delays and reductions creating cascading effects throughout the CTSA network. While institutions have adapted to maintain critical core operations, the uncertainty and administrative burden have created substantial challenges for research planning, personnel management, and institutional decision-making.

These findings are early warnings of serious threats to research continuity and innovation in the United States. The impact extends beyond immediate financial concerns to fundamental questions about research direction, institutional autonomy, and the long- term sustainability of translational science programs. As one respondent noted, this represents "nothing against the tremendous support of our program officer who is trying his best," but rather reflects systemic challenges that require coordinated solutions at the policy level.

Moving forward, addressing these challenges will require enhanced transparency, consistent communication, and recognition of the critical role CTSA programs play in advancing translational research and training the next generation of clinical scientists.

Clinical Research Forum

2001 K Street NW, 3rd Floor North Washington, DC 20006

(202) 367-1176

www.clinicalresearchforum.org

Copyright © 2025 All Rights Reserved

By: Dane Christiansen and Kira Flaherty, Washington Representatives

August 22, 2025

Congress began to actively push back on administration efforts to reorganize the Department of Health and Human Services (HHS) and disrupt grant and program funding through the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). Senator Katie Britt (R-AL) led a group of thirteen Republicans that sent correspondence to the administration sternly asking that FY25 NIH funding be distributed as intended. Shortly after the letter was sent, the Senate Appropriations Committee marked up its FY26 L-HHS Appropriations Bill and reported the measure out of committee with overwhelming bipartisan support. The Senate bill calls for increasing NIH funding by $400 million and level-funds nearly all other HHS programs while maintaining existing agency structure and line items. Moreover, the Senate bill includes policy riders that:

• Maintain the current approach for setting indirect costs (F/A) rates.
• Restrict the proposed use of multi-year funding for research projects.
• Object to the RIF and reorganization and encourage proper staffing to maintain existing functions.

The House Appropriations Committee was set to consider its FY26 L-HHS Bill ahead of the August congressional recess, but that markup was canceled and it is unclear if it will be rescheduled. The Senate FY26 L-HHS Appropriations Bills includes the following items of interest:

-$8.84 billion for the Health Resources and Services Administration (HRSA), near-level funding from FY25.

-$9.15 billion for the Centers for Disease Control and Prevention (CDC), near-level funding from FY25.

-$1.5 billion for the Advanced Research Projects Agency for Health, level funding from FY25.

-$7.43 billion for the Substance Abuse and Mental Health Services Administration (SAMHSA), near-level funding from FY25.

-$345.38 billion for the Agency for Healthcare Research and Quality (AHRQ), a slight decrease of roughly $14 million from FY25.

-$48.7 billion in total funding for the NIH, a roughly $400 million increase over FY 2025.

-$938.32 million for the National Center for Advancing Translational Sciences (NCATS), a proposed increase of $10 million over FY 2025.

• $629.56 million for the Clinical and Translational Science Awards (CTSA) Program, a proposal level with FY 2025.

-$2.46 billion for the Office of the Director, a proposed decrease of $145.00 million below FY 2025, including $572.40 million for the Common Fund, a proposed decrease of $100.00 million below FY 2025.

-Detailed committee instructions on the IDeA CTR and the CTSA programs.

By: Dane Christiansen and Kira Flaherty, Washington Representatives

July 25, 2025

Congress managed to narrowly pass H.R.1, the Big Beautiful Bill Act, sending the bill to the President’s desk for a July 4^th signing ceremony. H.R. 1 used a mechanism known as budget reconciliation, which meant that it could pass with a simple majority, but also that it could only include provisions relevant to taxes and spending on entitlement programs (like Medicaid and SNAP). Ultimately, the measure included the fix for Medicare physician reimbursement, telehealth provisions, and the Kids Access to Care Act, but restructured and restricted Medicaid benefits. The final analysis from the Congressional Budget Office said that the bill would create 10 million uninsured while adding $3.4 trillion to the national debt.

Congressional Republicans followed up on H.R.1 by enacting another administration priority, a recission package focused on clawing back FY 2025 funding for foreign aid programs and public broadcasting. The final package rested on a demand from Senate appropriators to carve out global health funding and maintain support for tribal broadcasters. The White House has indicated they are preparing a subsequent recission package focused on funding for the Department of Education, but any action will need to take place before the fiscal year ends on September 30^th.

Before adjourning for the August recess, both the House and Senate Appropriations Committee sought to advance as many Fiscal Year (FY) 2026 appropriations bills as possible. The House marked up a handful of measures maintaining VA research funding and enhancing Department of Defense research funding while providing modest funding cuts for FDA and deep cuts for the EPA. The Senate maintained similar support for VA research but opted to maintain a traditional bipartisan process that advanced increased FDA funding and only modest EPA funding cuts. Both chambers expressed interest in marking up their Labor-HHS-Education Bills, but neither markup has yet to be announced.

By: Dane Christiansen, Washington Representative

June 26, 2025

Congress has begun marking up bills for the Fiscal Year (FY) 2026 appropriations process. True to form, the House is moving on bills before the Senate and has started with the easier bills while planning to progress to more difficult bills later. The House Appropriations Committee is currently scheduled to mark up its Labor-HHS-Education measure (which provides funding for NIH, ARPA-, CDC etc) on July 24^th, just ahead of the August recess. Thus far, the House Appropriations Committee has considered the Veterans Affairs, and related agencies (MilCon-VA) and the Department of Defense (DoD). The Committee paused the markup for agriculture, rural development, the Food and Drug Administration, and related agencies (Ag-FDA) before fully approving the measure on June 24^th. The House bills provide relatively stable funding and advance some emerging administration priorities (a summary of key provisions is included below).

• The FY 2026 House MilCon-VA Appropriations Bill, corresponding Committee Report, and additional information can be found here.
• The FY2026 House Ag-FDA Appropriations Bill, corresponding Committee Report, and additional information can be found here.
• The FY 2026 DoD Appropriations Bill, corresponding Committee Report, and additional information can be found here.

MilCon-VA

• $124.17 billion for the Veterans Health Administration, a reduction of $8.36 billion from FY 2025. 
  • $943 million for the VA Medical and Prosthetic Research Program, level-funded from FY 2025.

  Ag-FDA

• $3.2 billion in discretionary funding for the FDA, a decrease of $1.5 million from FY 2025.
  • $1.54 billion in Prescription Drug User Fees, an increase of $121.63 million over FY 2025.
  • $445.81 million in Medical Device User Fees, an increase of $83.43 million over FY 2025.
  • $665.44 million in Human Generic Drug User Fees, an increase of $51.9 million over FY 2025.
  • $55.73 million in Biosimilar Biological Products User Fees, an increase of $24.62 million over FY 2025.
  • $712 million in Tobacco Products User Fees, level-funded from FY 2025.
  • $9.48 million for the Priority Review Vouchers, Pediatric Diseases Program, an increase of $993 thousand over FY 2025.

  DoD

• $40.92 billion for the Defense Health Program, a reduction of $532.11 million from FY 2025.

• $700 million for the Congressionally Directed Medical Research Program, an increase of $50 million over FY 2025 (but notably less than the traditional, FY 2024 funding level of $1.5 billion before it was cut through the current CR).

Meanwhile, the Senate is still considering a path forward on H.R. 1, the One Bill Beautiful Bill Act or Budget Reconciliation. Lawmakers are still working to balance tax cuts with reduced entitlement spending. Right now, positive patient care proposals are in the mix such as Medicare Physician Reimbursement, the Accelerating Kids Access to Care Act, and the Orphan Cures Act. Concerningly, proposals jeopardizing coverage, access, and patient care are also being debated including reducing Medicaid and SNAP benefits, and capping student loans for medical school students. Congress is prioritizing advancing appropriations and finalizing H.R.1 ahead of the August congressional recess.

By: Dane Christiansen, Washington Representative

May 27, 2025

In mid-May, the administration released its “skinny” budget request to Congress for Fiscal Year (FY) 2026. The proposal is extremely lite on detail and totals less than 50 pages for the entire federal government. The document calls for 40% funding cuts to NIH and deep reductions to other research, public health and patient care activities (doubling down on requested 20% cuts from the previous Trump administration). In any year, the budget request is a non-binding set of recommendations, but the draconian nature of the cuts will make it difficult for lawmakers to take seriously (particularly considering the FY 2026 appropriations process is already well underway). A summary of key information is included below.

• 32.7 billion in discretionary funding for the National Institutes of Health, a proposed decrease of $17.97 billion from FY 2025.

• Congress is asked to create five new “focus areas”: the National Institute on Body Systems Research, the National Institute on Neuroscience and Brain Research, the National Institute of General Medical Sciences (which currently exists), the National Institute of Disability Related Research, and the National Institute on Behavioral Health.
• Congress is asked to eliminate funding for the National Institute on Minority Health and Health Disparities, the Fogarty International Center, the National Center for Complimentary and Integrative Health, and the National Institute on Nursing Research.
• The Advanced Research Projects Agency for Health is maintained.

   

• $4.35 billion in discretionary funding for the Centers for Disease Control and Prevention, a proposed decrease of $3.59 billion from FY 2025.

• Congress is asked to consolidate funding for the HIV/AIDS, Viral Hepatitis, STD, and TB Prevention programs (which include opioid work too) into a single funding line and reduce the overall allocation to $300 million from $1.39 billion in FY 2025.
• Congress is asked to eliminate the National Center for Chronic Disease Prevention and Health Promotion, the National Center for Environmental Health, the National Center for Injury Prevention and Control, the Global Health Center, Public Health Preparedness and Response, and the Preventative Services Block Grant.

   

• $7.18 billion in discretionary funding for the Health Resources and Services Administration (specifically, programs that have been housed here that would now be moved elsewhere in HHS), a proposed decrease of $1.73 billion from FY 2025.

• Congress is asked to reduce or eliminate the Maternal and Child Health Programs, education and training activities, Health Workforce Programs, and family planning activities.

   

• $6.23 billion in discretionary funding for the Substance Abuse and Mental Health Services Administration, a proposed decrease of $1.07 billion from FY 2025.

• Congress is asked to eliminate the Mental Health Programs of Regional and National Significant, Substance Use Prevention Programs of Regional and National Significance, and the Substance Use Treatment Programs of Regional and National Significance.

   

• $2.99 billion in discretionary funding for Program Management at the Centers for Medicare and Medicaid Services, a proposed decrease of $674 billion from FY 2025.

   

• $247 million in discretionary funding for the Agency for Healthcare Research (AHRQ) and Quality, a proposed decrease of $129 million from FY 2025.

• Congress is asked to make AHRQ part of the new Office of Strategy.

   

• $530.96 million in discretionary funding for the Office of the HHS Secretary/Office of the Assistant Secretary for Health, a proposed decrease of $180 million from FY 2025.

• Congress is asked to migrate core activities to the new Administration for a Healthy America.
• Congress is asked to eliminate the Sexual Risk Avoidance Program and the Teen Pregnancy Prevention Program.
• Congress is asked to reduce funding for the Office of Minority Health and the Office on Women’s Health.

   

• $500 million for “Make America Healthy Again”, a proposed increase of $500 million from FY 2025.

• The allocation requested for nutrition, physical activity, healthy lifestyles, over-reliance on medication and treatments, the effects of new technological habits, environmental impacts, and food and drug quality and safety is significantly less than the amount eliminated for existing programs already working in these areas.

The White House FY 2026 budget documents can be viewed here.

The Republican House narrowly passed H.R. 1 the “big, beautiful bill” advancing budget reconciliation negotiations. The House proposal was fluid with many modifications to rally enough votes. Ultimately though, the package includes controversial provisions related to the SALT tax and reductions in benefits for SNAP and Medicaid coupled with drastic changes to student loans. The Senate has called the House package a non-starter and further negotiations toward a final package lie ahead. H.R. 1 information can be found here. A comprehensive summary of key healthcare and education elements from the current House package can be found here, here, and here.

By: Dane Christiansen, Washington Representative

April 25, 2025

On Tuesday, April 15^th, 250 scientists from across the country traveled to Capitol Hill to meet with Senators and Representatives and advocate for the full spectrum of medical research. The community’s annual Capitol Hill Advocacy Day was part of the Translational Science meeting and saw so much interest for 2025 that participation had to be capped. Ultimately, advocates representing 33 states, DC, and Puerto Rico met with congressional staff to educate them about the value and importance of medical research, including national competitiveness, local investment, and patient impact. To coincide with the 2025 Hill Day, CCTS launched a new website to serve as a central hub for advocacy information and to provide updates on key issues and activities. Please visit, https://coalition4cts.org/.

Despite the headlines about attacks on science and scientific infrastructure, Hill Day advocates saw strong support for their efforts from both sides of the aisle. While offices acknowledged that FY 2026 will be a challenging year for federal spending, broad support remains for community priorities. Specifically, advocates were calling on Congress to provide:

• The National Institutes of Health (NIH) with at least $51.3 billion for the National Institutes of Health, roughly a 9% increase over FY 2025.
• A restoration of funding for the Cancer Moonshot, All of Us Research Program, BRAIN Initiative and related programs previously supported through the 21^st Century Cures Act.
• The National Center for Advancing Translational Science (NCATS) at NIH with a proportional 9% funding increase for FY 2025, including:

• At least $650 million in dedicated line-item funding for the flagship Clinical and Translational Science Awards (CTSA) program, an increase of $20.5 million over FY 2025. The CTSA program is central to ongoing efforts to modernize and enhance the full spectrum of medical research at NIH, and annual committee instructions and funding serve an important function of preserving the size, scope, and strategic direction of CTSAs.
• At least $90 million in appropriated funding for the Cures Acceleration Network (CAN), an increase of at least $20 million over FY 2025.

• The Centers for Disease Control and Prevention (CDC) with at least $11.58 billion, an estimated increase of $2.37 billion over FY 2025, and invest in various chronic disease activities.
• The Agency for Healthcare Research and Quality (AHRQ) with at least $500 million, an estimated increase of $126.7 million over FY 2025, and continue to preserve the integrity of this distinct and impactful agency.
• A restoration of funding for the DOD Congressionally Directed Medical Research Program and its individual line-items and research programs to their full FY 2024 levels.

More broadly, advocates asked Congress for support for science including the pipeline for young investigators, investment in the health workforce (particularly for rural care), and enhancements to patient care. Participants used local stories and personal anecdotes to better connect national resources with local progress and development. Outreach will continue as Congress continues to work on FY 2026 appropriations and related policy items.

BRAIN-COMPUTER INTERFACE THAT HELPS A PARALYZED MAN TO SPEAK WINS NATIONAL CLINICAL EXCELLENCE AWARD

Other winners include a new treatment for common food allergies and a novel approach to telemedicine that improves cure rates of hepatitis C

Washington, D.C. – April 15, 2025– The Clinical Research (CR) Forum , a non-profit membership association of top clinical research experts and thought leaders from the nation’s leading academic health centers, awarded its most prestigious honor, The Herbert Pardes Clinical Research Excellence Award, to Dr. David M. Brandman of University of California, Davis, School of Medicine. Dr. Brandman and his team demonstrated that brain-computer interfaces have moved beyond a proof-of-principle demonstration to a device that is useful to people. They implanted four small devices in the speech area of the brain of a 46-year-old man with ALS, enabling him to “speak” by using his recorded brain signals. The patient is part of an ongoing clinical trial called BrainGate2, and it offers hope for thousands of people living with paralysis today. The study was published in the New England Journal of Medicine. See video.

This study was recognized during the CR Forum’s annual Top 10 Clinical Research Achievement Awards on April 14^th at the Washington Hilton Hotel in Washington, D.C. The Top 10 Awards highlight outstanding research advances that involve both innovation and impact on human diseases. A complete list of the 2025 Top 10 Award Winners is available on the website at https://www.clinicalresearchforum.org/page/TopTen .

“This study is spectacular, in that not only can this man communicate with his family and maintain his livelihood, but he is actually able to speak using recordings of his own voice,” said Harry P. Selker, MD, MSPH, CR Forum Board Chair and Dean of the Clinical and Translational Science Institute at Tufts University. “Indeed, all the Top 10 studies are scientifically brilliant, and have the potential to improve millions of lives, from advancing research in rare genetic disorders, to finding new treatments for food allergies and ear infections in children and reprogramming immune cells to fight cancer. I cannot emphasize enough the pride I feel for the amazing work of our colleagues and for clinical research as a field.”

The Herbert Pardes Clinical Research Excellence Award, named in honor of CR Forum Board Vice Chair Dr. Herbert Pardes for his profound impact on clinical research and academic medicine, is awarded to the research study that best shows a high degree of innovation and creativity, advances science, and has an impact upon human disease. Dr. Pardes passed away last fall after a distinguished career as Vice Chairman of the Board of Trustees at New York-Presbyterian Hospital and as the long-time Dean of the Faculty of Medicine at the College of Physicians & Surgeons of Columbia University . The award comes with a $7,500 prize.

Two additional studies received Distinguished Clinical Research Achievement Awards for their creativity, innovation, and novel approach that demonstrates immediate impact on the health and well-being of patients:

• RCT for Treatment of Food Allergies , nominated by Johns Hopkins University and published in the New England Journal of Medicine in February 2024, showed that omalizumab, an FDA-approved drug for the treatment of asthma, was also effective in protecting patients with multiple, severe food allergies from potentially life-threatening reactions. Dr. Robert Wood and his team led this ground-breaking study, which led to FDA approval of this existing medication for the treatment of multiple food allergies. Previously, there was only one FDA-approved medication for food allergies, and it was only for peanuts. Omalizumab showed effectiveness with milk, egg, cashew, walnut, and hazelnut, as well as peanuts. See video.
• Hepatitis C Treatment through Facilitated Telehealth in Opioid Use Disorder , nominated by the University at Buffalo, demonstrated that facilitated telemedicine for patients that had contracted hepatitis C due to opioid use disorder increased the cure rate to 90%, versus 39% in usual care. Further, two years later, those that were cured of hepatitis C showed significant decreases in substance abuse. Dr. Andrew Talal and his team concluded that facilitated telemedicine to treat hepatitis C, integrated with opioid use disorder treatment, was a highly effective method to cure hepatitis C and benefit opioid use disorder. See video.

Since 1996, the Clinical Research Forum has enabled the sharing of best practices in clinical research, informed meaningful policy dialogues and increasingly played a national advocacy role in support of clinical research.

CR Forum congratulates all the 2025 Top Ten Clinical Research Achievement Award recipients and finalists for groundbreaking, clinical and translational research advances that benefit the health and welfare of all Americans, and reflect the influential work being done by investigators at 60 research institutions and hospitals across the United States, as well as partner institutions around the world.

# # #

About the Top Ten Clinical Research Achievement Awards

Recognizing the need to celebrate our nation's clinical research accomplishments that involve both innovation and impact on human disease, the Clinical Research Forum conducts an annual competition to determine the ten outstanding research accomplishments in the United States. These major research advances represent a portion of the annual return on the nation's investment in the health and future welfare of its citizens. 

About the Clinical Research Forum

The mission of the Clinical Research Forum is to catalyze and sustain an environment in which clinical and translational research and researchers will thrive and advance human health and well-being for all. For more information, visit www.clinicalresearchforum.org.

1. What does it mean for a Top 10 Award-winning study to be from your CTSA?

The Stanford CTSA is deeply invested in advancing biomedical innovations and cutting-edge transdisciplinary research. Our location in the heart of an exceptional biomedical innovation ecosystem means that we focus on translating technological innovations into advances that improve human health.  Winning the top 10 Award is an incredible honor and a highly valued recognition from our peers of our approach: translating our basic science discoveries and technological advances into medical breakthroughs that benefit patients, their families and lead to enhanced management and treatment of chronic diseases, such as diabetes.

The Teamwork, Targets, Technology and Tight Control (4T) study recognized by the CRF Top 10 Award is a perfect example of the capabilities enabled by the Stanford CTSA. The 4T study led by Dr. David Maahs and colleagues implemented a team-based program to initiate continuous glucose monitoring (CGM) within the first month of diabetes diagnosis combined with weekly population health dashboard-facilitated remote patient monitoring (RPM) for all young people with new-onset type 1 diabetes (TlD} to significantly improve glycemia. Their study offers a model for sustainable use of digital technologies that makes a significant contribution to the public health goal of managing the costs and burden of chronic diseases using innovative digital health approaches. The study is also an excellent illustration of the transdisciplinary collaboration that we believe is a significant strength of our Stanford CTSA: bringing together investigators from multiple disciplines, including Pediatric Endocrinology, Management Science and Engineering, Digital Health Research and the CTSA-supported Quantitative Sciences Unit. 

The Top 10 Award also performs a function that is very important to us. It highlights and enables us to share the research innovations we develop locally more broadly to the scientific community with benefits for our patients, our biomedical research enterprise, and for health care more broadly. Our goal at the Stanford CTSA is not only to develop leading technologies and demonstrate scientific leadership in critical areas of biomedicine but also to disseminate, educate and improve our ability to implement these advances in the frontlines of health care across the country.

2. How does the Stanford CTSA help further clinical and translational research?

The Stanford CTSA emphasizes advancing the Science of Translation through our focus on Rigor and Reproducibility, and Team Science. The Stanford CTSA’s programs in clinical, translational and science of translation research and education (CTSRE) have been designed to extend from the earliest stages of the translational pipeline to the “final mile” of implementation science at the patient level. The Stanford CTSA has a history of pioneering innovations in translational science with our Biodesign program that is a model of transdisciplinary collaboration between schools of engineering, business and medicine and health outcome programs that is expert in using large-scale databases to probe critical areas of disease risk and management. The tradition of innovation continues with our CTSA leading efforts in areas of Rigor and Reproducibility, and also Artificial Intelligence applied to Real-World data for advancing translational science research and education. Stanford CTSA investigators are acknowledged leaders in field of Artificial intelligence, real-world data, innovative clinical trial design and rigor and reproducibility in science. They also contribute to research capacity in these areas within the CTSA network. The Stanford Program on Rigor and Reproducibility (SPORR) leads the nation in developing educational and training resources that help implement principles and practices that make biomedical research-from the lab to the clinic and the population- rigorous and reproducible. Ensuring rigorous and reproducible research practices is an integral part of the education we provide to our trainees throughout our CTSA.  Indeed, our CTSA’s educational and training programs integrate the scientific advances in all these areas to train the next generation of physician-scientists to serve as leaders of our biomedical research enterprise, translating fundamental basic and technological findings into clinical care.

As part of the national consortium of CTSAs, our impact extends beyond our institutional boundaries. The Stanford CTSA actively collaborates with other CTSA’s in the network to advance translational science and disseminate scientific innovations. For example, Stanford CTSA partnered with Stanford GReGOR, one of 6 sites in the National Institutes of Health Genomics Research to Elucidate the Genetics of Rare disease (GREGoR) consortium and with other CTSAs to develop a proposal to extend the reach of cutting-edge genomic medicine tools, hitherto available only at large academic medical institutions, to patients in rural areas. This example captures an important aspect of the work of the Stanford CTSA: cutting-edge technological innovations in genomic medicine pioneered at Stanford that will be disseminated in partnership with other CTSA’s to improve national health outcomes for rural populations.

3. How important is the CTSA funding to future research initiatives at your institution?

We have always recognized that CTSAs are a critical part of the nation’s investment in clinical and translational research which ensures that discoveries in basic sciences translate to tangible health care approaches and treatments for patients and communities.

As we move to the future the Stanford CTSA will augment the development and implementation of innovative, data driven, and clinical operational approaches to accelerate and scale translational research and science of translation efforts. Stanford CTSA is a pioneer in use of AI and real-world data to produce real-world evidence for translation. The national CTSA consortium extends the reach and benefits of the innovations we develop at Stanford throughout the CTSA network.   Thus, the benefits of innovations enabled by the CTSA extend beyond our institutional boundaries to health careand most importantly to patients themselves.

Simply put, our CTSA’s future research initiatives will advance biomedicine and help deliver more treatments to more people more quickly.

By: Dane Christiansen, Washington Representative

March 21, 2025

Hours ahead of a deadline on Friday, March 14^th, at midnight, the Senate passed a CR for the remainder of FY 2025, averting a government shutdown. While the measure ultimately passed on a near-party line vote, it was able to move forward when Democrats helped provided Republican colleagues with the 60 votes necessary to clear procedural hurdles. The FY 2025 CR was couched by Senate Democratic leaders as the lesser-of-two-evils, providing congressional guidance and legally enacted funding for all federal programs rather than risk the expiration of enacted legislation and a shutdown while the administration seeks to gut or reform departments and agencies wholesale. The CR had narrowly passed the House days prior and was vocally supported by the President. The text of the CR can be found here and a section-by-section Summary of the CR can be found here . Additional information can be found here. Key items include:

• The National Institutes of Health (NIH), the Advanced Research Projects Agency for Health (ARPA-H), public health programs and patient care programs are level-funded (or near level-funded) at their FY 2024 levels (summary below). It is also our understanding that report language and related guidance will continue to stand and provide details for specific allocations. 
  • $8.88 billion for the Health Resources and Services Administration (HRSA). 
  • $9.22 billion for the Centers for Disease Control and Prevention (CDC). 
  • $46.76 billion in discretionary funding for NIH. 
  • $1.5 billion for ARPA-H. 
  • $369 million for the Agency for Healthcare Research and Quality (AHRQ).
  • $3.24 billion for the National Institute of General Medical Sciences (NIGMS). 
    • $430.96 million for the Institutional Development Awards (IDeA) program. 
  • $534.40 million for the National Institute on Minority Health and Health Disparities (NIMHD). 
  • $928.32 million for the National Center for Advancing Translational Sciences (NCATS). 
    • $629.56 million for the Clinical and Translational Science Awards (CTSA) Program (FY 2024 Report Language listed below). 

Clinical and Translational Science Awards [CTSA] Program.— The Committee provides $629,560,000 for the CTSA program. The Committee once again emphasizes that allocated resources shall be used to provide additional support to CTSA hubs and further enhance ongoing activities. The Committee maintains its strong support for the CTSA program and reaffirms previous language preserving the size, scope, and historic mission of the CTSA program, including the direction that no competitively funded hub shall receive less than 95 percent of the resources that were provided prior to fiscal year 2022. The CTSA program has helped modernize the Nation’s approach to effective and efficient medical research and will continue to be fully supported to facilitate further scientific progress through this critical infrastructure. Finally, the CTSA program is encouraged to catalyze emerging opportunities in AI, big data, and other areas, while maintaining commitment to critical activities, such as training the next generation of cutting-edge physician scientists.

• By level-funding federal programs, the final FY 2025 CR forgoes additional funding proposed by the Senate (that complied with the enhanced spending limits agreed to under the Fiscal Responsibility Act). This approach forfeited the additional resources provided by the Senate to backfill funding shortfalls for the Cancer Moonshot, BRAIN Initiative, and similar programs at NIH funded through the 21st Century Cures Act.
• The CR extends telehealth flexibilities for the remainder of the fiscal year but does not include a high-profile fix to Medicare Physician Reimbursement. Further, the CR does not include patient care legislation and various reauthorizations previously considered as part of the December 20th appropriations package that failed to move forward. Democratic Senators have reintroduced a number of these bills with the misleading title of the Bipartisan Healthcare Act considering the measure lacks Republican support currently.

By: Dane Christiansen, Washington Representative

February 21, 2025

While only being in office for one month, President Trump has pressed forward with his plan to rework the federal government. A slew of Executive Orders sought to freeze all (and then some) federal funding, dramatically downsize the federal workforce, and target core abilities for research agencies and institutions to dispense and manage grant funding. A slew of subsequent lawsuits has created a patchwork of legal rulings and ongoing court cases. Uncertainty remains and it is unclear how long current disruptions will persist and what any long-term damage to the US biomedical research enterprise and global completeness might be. It is important to note that recent administration attacks on NIH and medical research drew the first rebukes from prominent Republicans in Congress, citing concerns over damage to local economies and disruption to critical research advancing national interests.

On Capitol Hill, the Senate confirmed Robert F. Kennedy, Jr., as the next Secretary of the Department of Health and Human Services in a (largely) party-line vote that capped off a divisive confirmation process. Shorty after, a Make America Healthy Again commission was announced by the White House. Congress also began work on a massive budget reconciliation package that could outline deep cuts to entitlement programs and discretionary spending. The House is moving forward with a single bill while the Senate is working on a two-bill approach. There are already headwinds though as Republican holdouts in the House can effectively stymie the process due to the extremely slim majority in the chamber.

More urgently, Congress will need to pass some form of spending bill or another continuing appropriations resolution (CR) to keep the government open and operating past March 14th (when the current CR is set to expire). Any package will almost certainly require Democrat votes and bipartisan support at a time when progressive lawmakers are increasingly vocal and displeased with the actions of the White House and congressional Republicans.

Clinical Research Forum’s annual competition highlights major advances resulting from the nation’s investment in research

Media Contact: Andrea Van Hook, avanhook@clinicalresearchforum.org

Washington, D.C. – February 6, 2025 – The Clinical Research (CR) Forum will honor ten
outstanding clinical research studies at the 2025 Top Ten Clinical Research Achievement
Awards at the Washington, D.C. Hilton on April 14, 2025.

These 10 award-winning studies exemplify major advances resulting from the nation’s investment in research to benefit the health and welfare of its citizens. They reflect the influential work being conducted by investigators at nearly 60 research institutions and hospitals across the United States and at partner institutions from around the world. All nominated studies were published in peer-reviewed journals during 2024.

At the awards ceremony on April 14, three of the Top 10 studies will receive additional
recognition and cash prizes:

• The Herbert Pardes MD Clinical Research Excellence Award, named in memory of CR Forum board member, Dr. Herbert Pardes, for his profound impact on clinical research and academic medicine; this award, which comes with a $7,500 cash prize, is for the research study that best shows a high degree of innovation and creativity, advances in science, and has an impact upon human disease.
  · The Distinguished Clinical Research Achievement Awards, presented to the top two studies that show creativity, innovation, or a novel approach that demonstrates an
  immediate impact on the health and well-being of patients. Each study will receive a
  $5,000 cash prize.

The Top 10 were selected based on the degree of innovation and novelty involved in the
advancement of science, contribution to the understanding of human disease, and potential impact upon the diagnosis, prevention, and/or treatment of disease. Several of the Top 10 were supported by Clinical and Translational Science Awards (CTSA) Programs, a national initiative run by the National Institutes of Health (NIH) that aims to accelerate the translation of research discoveries into improved patient care by supporting a network of medical institutions focused on advancing clinical and translational science, effectively bringing more treatments to patients faster through collaborative research efforts across laboratories, clinics, and communities.

2025 Top 10 Clinical Research Achievement Awardees (in alphabetical order by title):

An Accurate and Rapidly Calibrating Speech Neuroprosthesis – David Brandman, M.D., Ph.D. Assistant Professor, UC Davis School of Medicine

Diversity and scale: Genetic architecture of 2068 traits in the VA Million Veteran Program – Scott Damrauer, MD, Surgeon, Veterans Affairs Medical Center, Philadelphia, PA and Associate Professor of Surgery, Perelman School of Medicine at the University of Pennsylvania

Equitable implementation of a precision digital health program for glucose management in individuals with newly diagnosed type 1 diabetes – David Maahs, MD, PhD, Lucile Salter Packard Professor of Pediatrics, Stanford University

FOXO1 is a master regulator of memory programming in CAR T cells – Evan Weber, PhD, Assistant Professor, The Children’s Hospital of Philadelphia/University of Pennsylvania

Gene Editing for CEP290-Associated Retinal Degeneration – Tomas Aleman, MD, Irene Heinz Given and John La Porte Given Professor of Ophthalmology, Perelman School of Medicine at the University of Pennsylvania

Identifying Children Likely to Benefit from Antibiotics for Acute Sinusitis: A Randomized Clinical Trial – Nader Shaikh, MD, MPH, Professor of Pediatrics and Clinical and Translational Science, University of Pittsburgh School of Medicine and UPMC Children's Hospital of Pittsburgh, University of Pittsburgh

Integrated Hepatitis C-Opioid Use Disorder Care Through Facilitated Telemedicine. A Randomized Trial – Andrew Talal, MD, MPH, Professor of Medicine, University at Buffalo Jacobs School of Medicine and Biomedical Sciences

Noninvasive Ventilation for Preoxygenation During Emergency Intubation – Kevin Gibbs, M.D., Associate Professor, Wake Forest University School of Medicine

Omalizumab for the Treatment of Multiple Food Allergies – Robert Wood, MD, Professor of Pediatrics, Johns Hopkins University School of Medicine

Pomalidomide for Epistaxis in Hereditary Hemorrhagic Telangiectasia – Keith McCrae, MD, Staff and Professor of Molecular Medicine, Cleveland Clinic

In addition to the Top 10, the Clinical Research Forum also recognizes an additional 10 studies as finalists:

A comparative effectiveness trial of two biologic agents to block the action of interleukin-5 for the treatment of eosinophilic granulomatosis with polyangiitis – Peter Merkel, MD, MPH, Professor of Medicine and Chief, Division of Rheumatology, Perelman School of Medicine at the University of Pennsylvania

A Multimodal Video-Based AI Biomarker for Aortic Stenosis Development and Progression – Rohan Khera, MD, MS, Assistant Professor of Medicine (Cardiovascular Medicine) and of Biostatistics (Health Informatics); Director of Cardiovascular Data Science (CarDS) Lab, Yale University School of Medicine

A novel strategy to prevent and treat age related macular degeneration by repurposing metformin – Dimitra Skondra, MD, PhD, Professor of Ophthalmology and Visual Science, University of Chicago

AI generates covertly racist decisions about people based on their dialect – Sharese King, PhD, Neubauer Family Assistant Professor of Linguistics, University of Chicago

Behavioral Economic Approaches to Increase Physical Activity Among Patients With Elevated Risk for Cardiovascular Disease) – Alexander Fanaroff, MD, Assistant Professor of Medicine, University of Pennsylvania School of Medicine

Collaborative study of recovery of consciousness after severe brain injury – Nicholas Schiff, MD, Jerold B. Katz Professor of Neurology and Neuroscience, Weill Cornell Medicine

RNA lipid particle aggregates (RNA-LPAs) as cancer vaccines – Elias Sayour, MD, PhD, Bonne R. Freeman Professor for Pediatric Oncology Research, University of Florida

In-Utero Exposure to Psychotropic Medications and the Risk of Neurodevelopmental Disorders – Sonia Hernandez-Diaz, MD, DrPH, Professor of Pharmacoepidemiology, Harvard T.H. Chan School of Public Health

Nudges for Palliative Care – Katherine (Kate) Courtright, MD, MSHP, Assistant Professor of Medicine, Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania

Reducing Distracted Driving – Jeffrey Ebert, PhD, Director of Applied Behavioral Science, Penn Medicine Nudge Unit, Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania

About the Top Ten Clinical Research Achievement Awards
Recognizing the need to celebrate our nation's clinical research accomplishments that involve
both innovation and impact on human disease, the Clinical Research Forum conducts an annual
competition to determine the ten outstanding research accomplishments in the United States.
These major research advances represent a portion of the annual return on the nation's
investment in the health and future welfare of its citizens.

About the Clinical Research Forum and the Clinical Research Foundation
The mission of the Clinical Research Forum is to provide leadership to the national and clinical
translational research enterprise and promote understanding and support for clinical research
and its impact on health and healthcare. For more information,
visit www.clinicalresearchforum.org.

The Clinical Research Foundation is the charitable arm of the Clinical Research Forum. As a
501(c)(3), gifts to the foundation support the Top Ten Clinical Research Achievement Awards
and are tax deductible.

Event Details
The Top 10 Clinical Research Achievement Awards will be presented at Washington Hilton, 1919 Connecticut Ave NW, Washington, DC 20009. Please visit our website to learn more.

All Top 10 research studies will also be presented at Translational Science 2025, a major conference for clinical and translational science leaders and institutions. For session
information and registration, click here.

# # #

Dr. Herbert Pardes, a friend and mentor to many in academic medicine and beyond, passed away at the age of 89 on April 30, 2024. He will be greatly missed.

Dr. Pardes was a founding member of the Clinical Research Forum and served as Vice Chair until his death. During our early years, he was instrumental in establishing clinical and translational science as an enterprise at academic health centers. At the Clinical Research Forum, he launched the Top 10 Clinical Research Achievement Awards, which has grown in influence under his guidance and support. The top award, the Herbert Pardes, MD Clinical Research Excellence Award, was named in recognition of his many contributions to the Clinical Research Forum and the field.

Upon first meeting Dr. Pardes, you could be forgiven for not immediately realizing that this courteous and self-effacing man was an unrelenting driving force behind major improvements in mental health practice and treatment in the United States, as well as an important educator at one of the most prestigious medical schools in the country, and an advisor to Presidents. Some of his many roles included:

• Director of the National Institute of Mental Health and U.S. Assistant Surgeon General during the Carter and Reagan Administrations; he also was appointed to numerous health commissions by Presidents George W. Bush and Bill Clinton
• Dean, Columbia University Vagelos College of Physicians and Surgeons
• Inaugural CEO of New York-Presbyterian Hospital for 11 years, and Executive Chairman of the Board until his death
• President, American Psychiatric Association
• Chair, Association of American Medical Colleges

His influence and impact on American medicine is staggering. But in addition to that, he was an incredible friend, husband, father, grandfather, mentor, and colleague. People will say that he was a giant, but what a gentle giant – always generous, kind, and wise.

At the Clinical Research Forum, we are grateful for the time, effort, and dedication he shared with us, and will remember him and his lasting impact upon clinical and translational research. With that in mind, we wish to share this video clip of Dr. Pardes, where, as only he can, he described what clinical and translational research has meant to him and his own family.

In grateful appreciation,

Board of Directors and Staff of the Clinical Research Forum

Media Contact                                                                                                       April 16,2024
Andrea Van Hook
avanhook@clinicalresearchforum.org
202-367-2483

Follow us on Twitter: @CRForumUS, #TopTen

INNOVATIVE GENE EDITING APPROACH TO SICKLE CELL DISEASE WINS

NATIONAL CLINICAL RESEARCH EXCELLENCE AWARD

Genetic approach for most common hemoglobin disorder wins award from Clinical Research Forum; other award-winners include a low-cost intervention to prevent maternal death and sepsis worldwide, and the effectiveness of common aspirin in preventing post-surgical complications.

Washington, D.C. – April 16^th, 2024– The Clinical Research (CR) Forum , a non-profit membership association of top clinical research experts and thought leaders from the nation’s leading academic health centers, awarded its most prestigious honor, The Herbert Pardes Clinical Research Excellence Award, to Dr. James LaBelle of the University of Chicago . Dr. LaBelle’s study showed that a gene-editing approach has powerful potential to offer a lifelong cure to every patient with sickle cell disease. This hereditary disease affects more than 100,000 Americans; about 1 in 13 Black or African American babies are born with the sickle cell trait and may develop the disease. The average lifespan of an individual with sickle-cell disease is only 43 years.

This study was recognized during the CR Forum’s annual Top Ten Clinical Research Achievement Awards on April 2^nd at the Paris Hotel in Las Vegas, NV. The Top Ten Awards highlight outstanding research advances that involve both innovation and impact on human diseases. A complete list of the 2024 Top Ten Award Winners is available on the website: www.clinicalresearchforum.org/2024_Top10Awards .

“This year’s award winners demonstrate the immense value of our nation’s investment in clinical research, and the direct impact of that work on the health of millions of people in the United States,” said Harry P. Selker, MD, MSPH, CR Forum Board Chair and Dean of the Clinical and Translational Science Institute at Tufts University. “For many, these innovative studies and related clinical trials may represent the only hope for surviving a life-threatening disease. They also pave the way to advance new therapies and treatments that improve public health.”

The Herbert Pardes Clinical Research Excellence Award, named in honor of CR Forum Board Vice Chair Dr. Herbert Pardes for his profound impact on clinical research and academic medicine, is awarded to the research study that best shows a high degree of innovation and creativity, advances science, and has an impact upon human disease. (Dr. Pardes currently serves as Vice Chairman of the Board of Trustees at New York-Presbyterian Hospital and was the long-time Dean of the Faculty of Medicine at the College of Physicians & Surgeons of Columbia University.)

Sickle cell disease is the most common inherited blood disorder in the United States. It is so named because of the abnormal crescent or “sickle” shape that some red blood cells develop. Because of this shape and other abnormalities, blood cells can block the flow of blood and prevent parts of the body from getting oxygen. The only cure is bone marrow transplantation from a close genetically matched donor, something available to only 20% of patients. Otherwise, the emphasis is on managing symptoms of the disease.

Dr. LaBelle’s study, CRISPR-Cas9 Editing of the HBG1 and HBG2 Promoters to Treat Sickle Cell Disease, used an innovative genetic approach to increase fetal hemoglobin in the blood, a proven treatment for sickle-cell disease. The idea is to use gene-edited cells from the patients themselves to block a normally occurring genetic switch from fetal hemoglobin to adult or sickle hemoglobin, something that usually happens between 3 to 6 months of age. Preclinical experiments confirmed the effectiveness of this approach in producing high levels of fetal hemoglobin. In a subsequent study involving three patients with severe disease, the transplantation of gene-edited stem cells resulted in clinical improvement in disease severity over 6 to 18 months of follow-up. Because the patient’s own stem cells could be used, thus ensuring a genetic match, this treatment would be potentially available to everyone with the disease. The study was published in the New England Journal of Medicine in August 2023.See video.

Two additional studies received Distinguished Clinical Research Achievement Awards for their creativity, innovation, and novel approach that demonstrates immediate impact on the health and well-being of patients:

• Azithromycin to Prevent Sepsis or Death in Women Planning a Vaginal Birth , nominated by the University of Alabama-Birmingham and published in the New England Journal of Medicine in March 2023, demonstrated that a single oral dose of azithromycin, a common antibiotic used to treat infections, reduced the risk of maternal sepsis or death by 33% in women planning a vaginal birth. The study enrolled 29,000 women in seven low-income and middle-income countries with significant health disparities, and proved the feasibility of using this low-cost, accessibility intervention at scale. Dr. Waldemar Carlo and Dr. Alan Tita, the first back-to-back two-time Top 10 winner, led the international research team. See video .

   

• Prevent Clot: Aspirin or Low-Molecular Weight Heparin for Thromboprophylaxis after a Fracture , nominated by the University of Maryland and published in the New England Journal of Medicine in January 2023, demonstrated that aspirin was just as effective (in medical parlance, “noninferior”) as an injectable blood thinner in preventing pulmonary embolism in patients with traumatic fractures (such as from a car accident). The
  multi-center randomized clinical trial, which included more than 12,000 patients at 21 trauma centers in the U.S. and Canada, is the largest trial ever conducted on orthopedic trauma patients. This multidisciplinary collaboration between orthopedic and trauma surgeons points to the importance of evaluating techniques used to prevent post-surgical complications, like blood clots and infections, through high-quality, head-to-head comparison studies. Many patients with fractures will likely take a daily aspirin instead of receiving injections based on this study, at a much lower cost and less inconvenience to patients. See video .
  
  

Since 1996, the Clinical Research Forum has enabled the sharing of best practices in clinical research, informed meaningful policy dialogues and increasingly played a national advocacy role in support of clinical research.

CR Forum congratulates all the 2024 Top Ten Clinical Research Achievement Award recipients and finalists for groundbreaking, clinical and translational research advances that benefit the health and welfare of all Americans, and reflect the influential work being done by investigators at 68 research institutions and hospitals across the United States, as well as partner institutions around the world.

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About the Top Ten Clinical Research Achievement Awards

Recognizing the need to celebrate our nation's clinical research accomplishments that involve both innovation and impact on human disease, the Clinical Research Forum conducts an annual competition to determine the ten outstanding research accomplishments in the United States. These major research advances represent a portion of the annual return on the nation's investment in the health and future welfare of its citizens. 

About the Clinical Research Forum

The mission of the Clinical Research Forum is to provide leadership to the national and clinical translational research enterprise and promote understanding and support for clinical research and its impact on health and healthcare. For more information, visit www.clinicalresearchforum.org.

Media Contact: Andrea Van Hook, avanhook@clinicalresearchforum.org

Washington, D.C. – February 12, 2024 – The Clinical Research (CR) Forum will honor ten
outstanding clinical research studies at the 2024 Top Ten Clinical Research Achievement
Awards in Las Vegas, NV on April 2, 2024.

     At the awards ceremony, Clinical Research Forum will announce which study will receive the prestigious Herbert Pardes Clinical Research Excellence Award for the research study that best shows a high degree of innovation and creativity, advances science, and has an impact upon human disease. Two studies will receive additional recognition as Distinguished Clinical Research Awardees.

     These award-winning studies exemplify major advances resulting from the nation’s investment in research to benefit the health and welfare of its citizens, and reflect the influential work being conducted by investigators at nearly 60 research institutions and hospitals across the United States, as well as at partner institutions from around the world. All nominated studies were published in peer-reviewed journals during 2023.

     The Top 10 were selected based on the degree of innovation and novelty involved in the
advancement of science; contribution to the understanding of human disease and/or physiology;
and potential impact upon the diagnosis, prevention, and/or treatment of disease.

     The 2024 Top 10 Clinical Research Achievement Awardees are (in alphabetical order according to title):

A Randomized Controlled Trial to Optimize Patients Selection for Endovascular Treatment in Acute Ischemic Stroke - SELECT2- Amrou Sarraj, MD, George M. Humphrey II Endowed Professor of Neurology, University Hospitals Cleveland Medical Center

Azithromycin to Prevent Sepsis or Death in Women Planning a Vaginal Birth  - Alan T.N. Tita, MD, PhD, MPH, Senior Vice Chair for Research and Innovation in the Department of Obstetrics and Gynecology, and Waldemar A. Carlo, M.D., co-Division Director of Neonatology, Edwin M. Dixon Chair in Neonatology Professor of Pediatrics, University of Alabama at Birmingham

Lobar or Sublobar Resection for Peripheral Stage IA Non-Small-Cell Lung Cancer- Nasser Altorki, MD, and David B. Skinner, MD, Professor of Thoracic Surgery, Weill Cornell Medicine

Non-invasive detection of cardiac allograft rejection with artificial intelligence– Demilade Adedinsewo, M.B., Ch.B., Assistant Professor of Medicine, Mayo Clinic

PREVENT CLOT- Robert V. O'Toole, MD, Professor, Division Head Orthopedic Trauma, University of Maryland Department of Orthopedics

Protect Trial: Protecting Nursing Home Residents from Infection and Hospitalization– Loren Miller, MD, MPH, Professor and Chief, Division of Infectious Diseases, Lundquist Institute at Harbor-UCLA

Stem Cell Gene Therapy for Patients with Sickle Cell Disease- James LaBelle, MD, PhD, Associate Professor of Pediatric Hematology/Oncology/Stem Cell Transplant, University of Chicago

The effects of government-led cash transfers on all-cause mortality in low- and middle-income countries- Aaron Richterman, MD,MPH, Instructor, Infectious Disease, Perelman School of MedicineRaymond and Ruth Perelman School of Medicine at the University of Pennsylvania

The GEMINI Study - Jonathan M. Davis, MD, Vice-Chair of Pediatrics and Chief of the Division of Newborn Medicine, Tufts University Medical Center

The PROMISE II Trial, Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia (PROMISE)- Mehdi H. Shishehbor, DO, PhD, MPH, President, Harrington Heart & Vascular Institute and Professor of Medicine, Cleveland University Hospitals Cleveland Medical Center

     At the awards ceremony on April 2, three of the Top 10 studies will receive additional
recognition and cash prizes:
· The Herbert Pardes MD Clinical Research Excellence Award, named in honor of CR
Forum board member Dr. Herbert Pardes for his profound impact on clinical research and
academic medicine; this award, which comes with a $7,500 cash prize, is for the
research study that best shows a high degree of innovation and creativity, advances
science, and has an impact upon human disease.
· The Distinguished Clinical Research Achievement Awards, presented to the top two
studies that show creativity, innovation, or a novel approach that demonstrates an
immediate impact on the health and well-being of patients. Each study will receive a
$5,000 cash prize.

All Top 10 Awardees will also be presenting their research at Translational Science 2024 on
April 2, 2024, in Las Vegas, NV.

About the Top Ten Clinical Research Achievement Awards
Recognizing the need to celebrate our nation's clinical research accomplishments that involve
both innovation and impact on human disease, the Clinical Research Forum conducts an annual
competition to determine the ten outstanding research accomplishments in the United States.
These major research advances represent a portion of the annual return on the nation's
investment in the health and future welfare of its citizens.

About the Clinical Research Forum and the Clinical Research Foundation
The mission of the Clinical Research Forum is to provide leadership to the national and clinical
translational research enterprise and promote understanding and support for clinical research
and its impact on health and healthcare. For more information,
visit www.clinicalresearchforum.org.

The Clinical Research Foundation is the charitable arm of the Clinical Research Forum. As a
501(c)(3), gifts to the foundation support the Top Ten Clinical Research Achievement Awards
and are tax deductible.

Media Contact: Andrea Van Hook, 202-367-2483, avanhook@clinicalresearchforum.org.

Event Details
The Top 10 Clinical Research Achievement Awards will be presented at Paris Las Vegas hotel, 3655 S Las Vegas Blvd, Las Vegas, NV 89109. Please visit our website to learn more.

All Top 10 research studies will also be presented at Translational Science 2024. For session
information and registration, click here. 

Study that had immediate impact on treatment of mild hypertension during pregnancy wins award from Clinical Research Forum; other award-winners include a novel approach to prevent malaria and a study showing a link between losing weight and lowering cancer risk in patients with obesity

Washington, D.C. - April 21st, 2023 - The Clinical Research (CR) Forum, a non-profit membership associate of top clinical research experts and thought leaders from the nation's leading academic health centers, awarded its most prestigious honor, The Herbert Pardes Clinical Research Excellence Award, to Dr. Alan Tita of the University of Alabama Birmingham. Dr. Tita's study demonstrated that treating non-severe high blood pressure with appropriate medications during pregnancy was beneficial and safe for women and their babies. These results have had an immediate impact on treatment in the United States.

This study was recognized during the CR Forum's annual Top Ten Clinical Research Achievement Awards. The Top Ten Awards highlight outstanding research advances that involve both innovation and impact on human diseases. A Complete list of the 2023 Top Ten Award Winners can be found at: https://www.clinicalresearchforum.org/page/2023Top10Finalists.

"This year's award winners demonstrate the immense value of our nation's investment in clinical research, and the direct impact of that work on the health of millions of people in the United States," said Harry P. Selker, MD, MSPH, CR Forum Board Chair and Dean of the Clinical and Translational Science Institute at Tufts University. "For many, these innovative studies and related clinical trials may represent the only hope for surviving a life-threatening disease. They also pave the way to advance new therapies and treatments that improve public health."

The Herbert Pardes Clinical Research Excellence Award, named in honor of CR Forum Board Vice Chair Dr. Herbert Pardes for his profound impact on clinical research and academic medicine, is awarded to the research study that best shows a high degree of innovation and creativity, advances science, and has an impact upon human disease. (Dr. Pardes currently serves as Vice Chairman of the Board of Trustees at New York-Presbyterian Hospital and was the long-time Dean of the Faculty of Medicine at the College of Physicians & Surgeons of Columbia University.)

The study, Treatment of Mild Chronic Hypertension in Pregnancy, was published in the New England Journal of Medicine in May 2022. Dr. Tita and his team, members of the Chronic Hypertension and Pregnancy (CHAP) Trial Consortium, showed that pregnant women with mild hypertension (typically defined as below <160/110 mm Hg) could be treated safely and effectively with current antihypertensive drugs with no increase in risk to the baby. Previously, there was consensus among the medical establishment to only treat women with severe hypertension (defined as above <169/110 mm Hg). Treating mild hypertension was controversial, out of concerns for the safety of the baby.  

In the United States, chronic hypertension develops in 2% or more of pregnancies. This condition disproportionately affects Black women and associated with greater risk of preeclampsia, preterm birth, lower birth weight, and perinatal death. For mothers, the conditions is associate with much greater risk of death, heart failure, stroke, pulmonary edema, and acute kidney injury.

The day the study results were announced, the American College of Obstetricians and Gynecologists and the Society for Maternal - Fetal Medicine issued statements recommending treatment of mild hypertension in pregnant women, thus changing clinical practice.

Two additional studies received Distinguished Clinical Research Achievement Awards for their creativity, innovation, and novel approach that demonstrates immediate impact on the health and well-being of patients:

• Safety and Efficacy of a Monoclonal Antibody against Malaria in Mali, nominated by the National Institute of Allergy and Infectious Diseases (NIAID), and represented by Dr. Peter Crompton, Chief of NIAID's Malaria Infection Biology and Immunity Section. This study produced ground-breaking results from a phase 2 trial of a novel approach to prevent malaria. The team evaluated the safety and efficacy of high or low doses of CIS43LS, a monoclonal antibody, against malaria infection during a 6-month rainy season when intense malaria transmission occurs. This trial provided the first proof-of-concept that a monoclonal antibody can protect from malaria in a 'real world' setting and paved the way for potentially transformative trials of monoclonal antibodies in populations at high-risk for malaria. 
• Association for Bariatric Surgery with Cancer Risk and Mortality in Adults with Obesity, nominated by the Cleveland Clinic and represented by Dr. Ali Animian, Director of Bariatric and Metabolic Institute at the Cleveland Clinic and a Professor Surgery at the Cleveland Clinic Lerner College of Medicine. This study evaluated the long-term effect of obesity, specifically whether it has an impact on the likelihood of developing cancer. They found that if we help patients to lose weight through weight loss surgery, we can significantly mitigate the risk of developing and dying from cancer. 

Since 1996, the Clinical Research Forum has enabled the sharing of best practices in clinical research, informed meaningful policy dialogues and increasingly played a national advocacy role in support of clinical research.

CR Forum congratulates all of the 2023 Top Ten Clinical Research Achievement Award recipients and finalists for groundbreaking, clinical and translational research advances that benefit the health and welfare of all Americans, and reflect the influential work being done by investigators at nearly 60 research institutions and hospitals across the United States, as well as partner institutions around the world. 

About the Top Ten Clinical Research Achievement Awards

Recognizing the need to celebrate our nation's clinical research accomplishments that involve both innovation and impact on human disease, the Clinical Research Forum conducts an annual competition to determine the ten outstanding research accomplishments in the United States. These major research advances represent a portion of the annual return on the nation's investment in the health and future welfare its citizens.

About the Clinical Research Forum

The mission of the Clinical Research Forum is to provide leadership to the national and clinical translational research enterprise and promote understanding and support for clinical research and its impact on health and healthcare. For more information, visit https://www.clinicalresearchforum.org/

At the awards ceremony, CR Forum will announce which study will receive the prestigious Herbert Pardes Clinical Research Excellence Award for the research study that best shows a high degree of innovation and creativity, advances science, and has an impact upon human disease. Two studies will receive additional recognition as Distinguished Clinical Research Awardees. 

These award-winning studies exemplify major advances resulting from the nation’s investment in research to benefit the health and welfare of its citizens, and reflect the influential work being conducted by investigators at nearly 60 research institutions and hospitals across the United States, as well as at partner institutions from around the world. All nominated studies were published in peer-reviewed journals during 2022.

The Top 10 were selected based on the degree of innovation and novelty involved in the advancement of science; contribution to the understanding of human disease and/or physiology; and potential impact upon the diagnosis, prevention, and/or treatment of disease.

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