Julie Locher, Professor Emeritus at UAB and Research Consultant, shared on LinkedIn:
“NIH just announced a major change to Career Development (K) Awards that could fundamentally alter how we train the next generation of clinical, behavioral, psychosocial, implementation, and health-services investigators.
Beginning with due dates on or after October 12, 2027, K award funds may no longer be used to support the conduct of a clinical trial, a clinical trial feasibility study, or an ancillary study to an existing clinical trial.
NIH will also eliminate the ‘Independent Clinical Trial Required’ K NOFOs.
For many K applicants, a traditional developmental trajectory has been:
Formative research – intervention development/refinement – pilot or feasibility trial – independent R-level research
Under the new policy, K awardees may gain clinical trial experience by participating in a trial led by a mentor or co – mentor. But if they want to lead a clinical trial themselves – even a small pilot or feasibility trial – they will need separate funding to support it.
NIH states that this change is intended ‘to better align K awards with their primary purpose of career development’, but the notice provides little explanation for why conducting a mentored pilot clinical trial is inconsistent with that purpose.
This raises several questions for me.
First, how do we train someone to become an independent investigator to conduct randomized controlled trials without allowing that person to lead a trial as part of the career development experience?
Second, how different does a K become from an F32 in this respect? F32 fellows already cannot lead independent clinical trials; instead, they may gain clinical trial experience through a study led by their sponsor or co-sponsor. Under this new policy, K awardees will face essentially the same restriction.
Yet a mentored K is supposed to represent a later stage in the progression toward research independence.
What is the developmental step forward if both mechanisms require the investigator to gain that experience through someone else’s trial?
Third, what happens to investigators at institutions where their mentors do not have funded clinical trials?
Many outstanding senior investigators do not conduct randomized clinical trials or have an ongoing funded project. And not every institution has the internal resources to provide separate funding for a K awardee’s trial.
This seems particularly important given NIH’s stated interest in broadening participation in NIH-funded research across investigators and institutions.
Requiring access to a mentor’s funded trial – or access to separate institutional or philanthropic funding-could unintentionally advantage investigators at large, research-intensive institutions with extensive clinical trial infrastructure and internal funding.
NIH acknowledges that there is more to come, stating that it is ‘actively working on additional strategies’ to support the development of scientists who can lead rigorous clinical trials.
How are others interpreting this bombshell?“