The ASCI has issued an open letter to the National Institutes of Health leadership regarding its recent proposed changes to K awards. The letter is co-signed by 30 professional organizations and foundations.
The letter responds to the proposed changes detailed in NIH’s “Notice of NIH Updates to Career Development (K) Award Programs” (NOT-OD-26-098) and “Request for Information (RFI): Input on Potential NIH Funding Approaches to Support the Development of Future Clinical Trial Investigators” (NOT-OD-26-095).
A clinician learns to run a trial by running one: a small, mentored study carried out on protected time during the K award. The study sections that review R01 applications, NIH’s main grants for independent research, expect evidence that a candidate has led a trial, along with the pilot data it produced. In NIH RePORTER records on 6,588 K01, K08, and K23 awardees from FY2010 to FY2020, those whose K included a trial did just as well as other K awardees in winning later NIH and R01 funding, and were nearly 2.5 times as likely to go on to lead their own NIH-funded trial. Two-thirds of these K trials are pilots, with a median enrollment around 60. If K funds can no longer pay for such studies, there is no ready source of alternate funds: industry has no product to sell in an implementation trial and foundation money is scarce. Trial training and the careers it launches would concentrate at a small set of well-funded institutions.
The letter asks NIH to do three things.
- Tier the clinical trial definition to differentiate feasibility, implementation, and ancillary studies from definitive trials.
- Keep the trial-permitted K01, K08, and K23 awards open and funded for at least five more years, while NIH works through the challenges of the new model, so the transition does not drive further attrition of physician-scientists.
- Shape the approaches described in the RFI so awardees have enough time to do the pre-trial work, apply for the RPG, and finish the trial in time to compete for independent funding.
NIH has spent decades investing in its scientific workforce, and the ability to design and lead clinical trials deserves the same sustained investment and stewardship. Trial leaders are the ones who bring NIH’s discoveries into patient care. The current pathway has supported them at 340 institutions in all 50 states and Puerto Rico; the ASCI and its co-signing societies stand ready to work with NIH on the design of these mechanisms.
The letter is the product of an ASCI working group chaired by Lilia Cervantes, MD, MSCS (University of Colorado School of Medicine) with the following members: Nisha Bansal, MD, MAS (University of Washington School of Medicine); Jeremy M. Berg, PhD (University of Pittsburgh School of Medicine); Charles S. Dela Cruz, MD, PhD (University of Pittsburgh School of Medicine); Holger K. Eltzschig, MD, PhD (University of Texas Medical School at Houston); Alessia Fornoni, MD, PhD (University of Miami Miller School of Medicine); Orlando M. Gutierrez, MD, MMSc (University of Alabama at Birmingham School of Medicine); Rajan Jain, MD (University of Pennsylvania Perelman School of Medicine); Suneil K. Koliwad, MD, PhD (University of California, San Francisco, School of Medicine); Jennifer W. Mack, MD, MPH (Harvard Medical School, Dana-Farber Cancer Institute); Ken Nakamura, MD, PhD (Gladstone Institutes); Kyu Y. Rhee, MD, PhD (Weill Cornell Medicine); and Ronald Sokol, MD (University of Colorado School of Medicine).