Dr. Zerhouni, director of the National Institutes of Health (NIH), recently unveiled his vision for the restructuring of clinical and translational research.1In this plan, academic centers would function as homes that combine basic science, clinical research, and training under an infrastructure supported by Clinical and Translational Science Awards (CTSAs; RFA-RM-06-002).2A major component of the CTSA involves the training of a new generation of clinical and translational researchers. Such training requires infrastructural support and a core of experienced mentors. I and many of my colleagues are concerned that insufficient emphasis is being given to the support of clinical research mentoring. Even with very substantial progress over the last decade and the development of several new NIH programs and awards with an emphasis on clinical or patient-oriented research training, more can be accomplished. Now represents an opportune time to dispense with existing myths and start afresh.3,4
Myth 1: The NIH, through the CTSA, K-series, T-series, and other award programs, provides ample support for mentors.
Aside from the K24 mechanism (see below), NIH awards with a mentoring component rarely provide support for protected time for the mentors. The request for applications (RFA) for the Institutional Clinical and Translational Science Award cites the word mentor (or mentored, mentoring, mentors) 61 times. Yet under the U54 CTSA RFA, salary support for mentors is specifically prohibited. Mentors may receive a small amount of funding annually for laboratory or other research costs. Since this is primarily a mechanism to restructure the clinical research enterprise, it is unclear why there is support for laboratory expenses but no support for mentors to teach and instruct junior investigators on the art of clinical investigation.
Other clinically or patient-oriented awards that require mentors rarely support mentoring activity (Table 1). Only the National Heart, Lung, and Blood Institute and National Eye Institute, under their K12 programs, permit direct funding of a mentor's salary. All other K12s, all K23s, all K22s, and all of the T-series awards require mentors but provide minimal, if any, funding for their activities.
Myth 2: The K24 mechanism supports sufficient numbers of investigators to mentor junior clinical and translational scientists.
The K24 mechanism is a well-conceived program that is absolutely essential if there is to be a robust pool of experienced clinical and translational investigators to mentor junior faculty and fellows. There are 301 active K24 awards funded by the NIH.4Since there are 125 academic medical schools where clinical investigation is practiced,5this represents an average of less than 2.5 K24-supported mentors per institution. This average is actually even lower if the multiple teaching hospitals or centers that many individual medical schools support are considered separately. The number of these awards has been relatively stable. In FY 2005, there were 264 new, competing, and continuing K24s compared with 260 in FY 2004, 298 in FY 2003, and 261 in FY 2002.6
Averages, however, do not accurately represent the distribution of K24 awards across various institutions (Table 2). One-third of the awards are held by just seven institutions (the various teaching hospitals under the Harvard University umbrella were grouped together because the new CTSA mechanism focuses on individual institutions rather than their affiliated centers). Half of the awards are held by just 14 institutions. One-third of the institutions with K24 awards have three or fewer, and over 35 of the academic medical schools in the United States have no active funding through this mechanism.
Some NIH agencies are much more supportive of mentoring activities than others, as evidenced by the number of K24s funded (Table 3). The National Institute of Diabetes and Digestive and Kidney Diseases (49), National Heart, Lung, and Blood Institute (38), and National Institute of Mental Health (37) support the largest number of these awards. The National Cancer Institute (NCI), despite having the largest single-agency budget (about $4.7 billion), currently funds only 21 K24 awards. This equates to approximately one supported mentor for every 3 of the 61 NCI-designated cancer centers nationwide. The number of K24 awardees is less than the number of NCI-designated comprehensive cancer centers (39). Are there so few mentors for a new generation of oncology-focused clinical and translational investigators? No wonder I, as a current K24 awardee, often feel like a lone tree in a clear-cut forest. Hysteria aside, there are, of course, others who do not have K24 support who mentor junior clinical cancer investigators. The question is whether they will continue these mentoring activities over the next decade without appropriate support or whether the next generation of clinical researchers will struggle to find experienced mentors. Dr. Zerhouni indicated himself that “…mentoring…require[s] dedicated time away from the escalating pressures of clinical-service demands.”1Dedicated time needs dedicated support.
In defense of the NIH, funding more K24s will require sufficient numbers of applications. In 2005, 76 new applications were funded from a pool of 149, for a 51% funding rate!7Part of the reticence to apply may be restrictions such as the requirement by some agencies (eg, NCI) for separate, active and peer-reviewed, patient-oriented grants to be held concurrently by the applicant. Also, especially for physician-scientists in the surgical subspecialties, overall salary levels may significantly exceed the NIH cap, thus making K24 support for up to 50% effort less attractive.
Myth 3: Once a faculty member becomes “senior,” she or he no longer needs support for mentoring activities as was necessary during “midcareer.”
The K24 mechanism supports only associate professors, midcareer investigators. Why is it assumed that full professors do not need the same type of support? With the current mode of reimbursement for clinical academicians in the United States,8all levels of clinically active faculty, including professors, are often forced to generate a substantial proportion of their salary through (nonacademic) clinical activity. The policy of limiting K24 support to associate professors should be reexamined, and it may be that an important pool of early professor-level faculty, who could be valuable mentors, are being missed.
Overall, we need to be certain that nascent clinical investigators embarking on their journey through clinical and translational research have a sufficiently strong support network of midcareer and senior mentors to be successful. Supporting this initiative by supporting these mentors will be imperative.