The crisis in developing and sustaining a career in biomedical research has been summarized recently in a high-profile perspective paper.1 Although the proposed strategies “to rescue U.S. biomedical research from its systemic flaws” are applicable to basic, clinical, and translational scientists, the perspective paper did not emphasize the unique challenges faced by MD or MD–PhD clinician–investigators who conduct clinical and translational research (CTR). Unlike PhD scientists, clinician–scientists have ample opportunities that are already in place for “alternate” career paths both in academia and the private sector, which are often more financially rewarding and gratifying, at least in the short term. Furthermore, clinician–scientists’ clinical responsibilities are unpredictable, and the even more crippling demands on their time compared with basic scientists frequently conflict with their research responsibilities.
Most important, there is a shortage of newly minted clinician–scientists, unlike the current overproduction of PhD scientists. Many preeminent clinician–scientists have been sounding the alarm of the vanishing clinical investigators for decades.2–4 The crisis persists in spite of a recently doubled National Institutes of Health (NIH) budget and the creation, since the 1990s, of NIH individual mentored K awards that are directed at junior faculty clinical scientists. Two NIH K awards focused primarily on patient-oriented research are particularly relevant for the purpose of this Perspective: K08 (Mentored Clinical Scientist Research Career Development Award) and K23 (Mentored Patient-Oriented Research Career Development Award).
Whereas overall-funded NIH grant applications nearly doubled from 1998 to 2007, most of the increase reflects awards to PhD investigators. Indeed, the number of NIH-funded clinician–scientists has not increased despite the establishment of NIH new investigator programs, a trainee loan repayment program, and NIH family-friendly initiatives. Furthermore, the success rate for new R01 (Research Project Grant) applications decreased by one-third, and there is a graying of NIH awardees, including first-time awardees.5 These statistics sparked debates as to whether the paradigms for physician training, including those for MD–PhD and K awardees, should be reinvented6–8 and how institutions should invest in their junior clinician–investigators.6,9 These discussions culminated recently in the NIH Physician–Scientist Workforce Working Group report.10
Increasing the Pipeline
The NIH Clinical and Translational Science Awards (CTSA) program was started in 2006 to strengthen and support CTR. It currently supports a national consortium of 62 academic health centers to transform and accelerate CTR. Recognizing the urgent need to increase the pipeline of CTR investigators, the CTSA has emphasized research education and career development (EdCD) of junior CTR investigators since its inception. CTR trainees learned by enrolling in formal course work and performing mentored research to increase team science competencies.6
In addition, the CTSA-funded institutional KL2 Mentored Clinical Research Scholars program supported a subset of high-potential and high-achieving medical professionals, such as MD, PhD, MD–PhD, and equivalent, who are junior faculty in academic health centers. The proposed career paths for these elite KL2 Scholars are to obtain an individual K or R award at the end of their two to three years of KL2 support and subsequently achieve independent research grants, such as an R01. Transitioning from mentored to independent investigator status is primarily focused on NIH K grant awardees and their transition to NIH R01 grants, referred to as the K2R transition.
In 2012, the CTSA National EdCD Committee established the Mentored to Independent Investigator Working Group to identify the best practices and barriers for the K2R transitioning of KL2 Scholars. The committee focuses on the acquisition of NIH R01 grants by K awardees because publicly available data on K and R01 awards are available from the NIH,5,11 and they account for the majority of career development and independent research grants, respectively. In this Perspective, we provide the committee’s mindset on and approach to the K2R transition based on a review of literature published between 1980 and 2014, as well as our collective experience as educators and mentors to this target population. We begin with a discussion of the challenges to sustaining and diversifying the CTR pipeline, and then we consider best practices of K2R programs and the factors critical to long-term CTR success. We conclude with recommendations for future research.
Sustaining the Pipeline: The K2R Transition Challenge
For the majority of junior CTR investigators, obtaining an individual K08 or K23 award is a landmark first step towards becoming an early-career investigator.6 Data from the NIH Office of Extramural Research3,5 show that between 2003 and 2013, the success rates for obtaining K08 or K23 awards fluctuated between 35% and 45%, and 80% of the K awardees subsequently applied for an R-series grant. Data from an earlier period (1997–2003) that tracked all 3,000 K08 and K23 awardees show that their K2R transition rate was 20% at 5 years after initial K funding, increased progressively between years 5 and 8, and reached a plateau at 40% at 10 years.12 Importantly, K23 awardees with MD degrees are four times more likely than non–K funded MD applicants to obtain independent grant funding.11 This “K advantage” makes a compelling case for continuing the K award programs for MD CTR investigators. However, the K2R process is tortuous and prolonged, requiring multiple grant submissions and resubmissions, and the success rate is suboptimal. Thus, there is indeed a crisis in sustaining the CTR investigator pipeline.
Because K2R funding peaks at eight years after initiation of K funding,3,12 more than half of K awardees who apply for R01 grants will experience a three-year gap of funding from termination of a K award to acquisition of an R award. This funding gap will likely lengthen in the present austere NIH funding climate. Therefore, there is an urgent need for continued institutional support during the K2R transition gap in order to retain the talent pool and maximize return on investment for the NIH, the junior CTR investigators, and their sponsoring academic institutions.
Diversifying the Pipeline
Additionally, mechanisms to increase the K2R success of women and those underrepresented in biomedical research should be developed to ensure a diverse and vibrant CTR workforce. The importance of diversity is underscored by the launching of the NIH Common Fund’s “Enhancing the Diversity of the NIH-Funded Workforce” initiative.13 Women now constitute a large proportion of the academic physician workforce (43% of assistant professors), NIH K awardees (44% of K23; 29% of K08),11 and CTSA KL2 Scholars (54%). Compared with male K awardees, women K23 awardees have a lower R01 application rate,14 as well as lower K2R success rates compared with men (19% versus 25% at 5 years, and 36% versus 46% at 10 years).12 Paradoxically, this transition gap cannot be simply accounted for by whether or not women have children.12 The gap is even more acute for underrepresented racial groups, which account for 5% and 8% of K08 and K23 awardees, respectively.11 A survey involving five CTSA academic health centers reports that race-based barriers include perceived lack of mentoring, isolation, difficulties in cross-cultural communications, discrimination, and differential performance expectations.15
Toward Best Practices for K2R Success
Best practices for training CTR investigators and promoting their K2R transitions are evolving. Results from institutional and national specialty-specific research development programs suggest that intensive interventions, such as grant writing workshops, and career support mechanisms, including mentoring, promote K2R transition.16 Additional common features include formal structured training such as course work, protected research time, a strong research environment, and hands-on research experience. In a comparison of centralized and decentralized career development programs within a single academic health center, Brown and colleagues17 reported that centralized training and mentoring oversight, like those built into the KL2 Scholars program, increase the likelihood of a junior CTR investigator securing future independent research funding. Data from the Harvard School of Public Health’s Program in Clinical Effectiveness reveal that predictors for future success in obtaining R funding include younger age (less than 40 years old) at time of program enrollment, generalist status, timely commencement of research publications, and early submission of extramural grants.18
It is generally agreed that the ingredients for successful K2R transition include formal mentorship, rigorous research training, sufficient protected time, adequate research support, collaborative and collegial interactions, pilot funding, and an academic culture that supports young CTR investigators.19 Some of these recommendations were endorsed by a recent Institute of Medicine report on the CTSA enterprise.20 However, there are few rigorous studies to identify factors that promote K2R transition, ensure long-term CTR career success, and limit attrition in the CTR workforce.
To facilitate research in this domain, Rubio and colleagues21 propose a theoretical model that potentially can be used to assess the relative importance and interplay between multiple factors that contribute to long-term CTR success. This model incorporates extrinsic (financial success, promotion, leadership positions, grants, and publications) and intrinsic (job, career, and life satisfaction) factors. Some of these characteristics could be improved through interventions at the institutional level. These include empowering CTR junior investigators through institutionally supported K2R programs; mentor training; and leadership training programs.
Formal K2R programs
Recently, several institutions in the CTSA Consortium have begun to offer structured K2R transition programs. For a few examples, see Harvard Catalyst’s Grant Review and Support Program (http://catalyst.harvard.edu/services/grasp/) and the University of North Carolina’s North Carolina Translational & Clinical Science Institute’s R-Writing Group (http://tracs.unc.edu/index.php/services/education/r-writing-group). Most programs are focused on preparation of R01 or equivalent grants. Venues include small-group writing workshops with rigorous timelines for grant deliverables and online grant writing and progress tracking tools. These programs require substantial institutional investment, but anecdotal evidence suggests that they increase K2R success. Additional research will be necessary to identify best practices that produce the best outcomes and are also cost-effective so that they can be broadly adopted by other academic health centers.
Mentoring and mentorship training
Mentorship is universally recognized as necessary and critical to biomedical research careers,22 including those of CTR investigators.23–25 Although mentoring matters, particularly in the current hypercompetitive medical research and health care environment, the mentor–mentee relationship has increasingly become a casualty of competition and crushing time demands in academia. This erosion parallels that occurring in the hypercompetitive corporate environment.26
The traditional academic mentoring model pairs a junior trainee with a more experienced senior investigator in the same academic discipline.27 Recently, there is a move beyond the traditional dyadic model to mentoring networks that include interdisciplinary and peer mentoring.28 This is a natural evolution for CTR investigator mentoring: CTR is by definition interdisciplinary and team based, and it is difficult for a single mentor to perform diverse mentoring functions. Specifically, emphasis on the mentor–mentee relationship is reciprocal, and the partnership must be cultivated through bidirectional exchanges.
Mentoring at its best should support the mentees’ career functions as well as psychosocial personal functions. A survey of those CTR faculty who initiated their K08 and K23 awards between 2006 and 2009 shows that the majority were satisfied with current mentoring relations and that mentor behaviors, such as level of collegiality and positive outlook, appear to be directly associated with mentees’ career satisfaction.29 Furthermore, mentees perceived that their mentors were effective in supporting many aspects of career functions, including modeling professional and ethical behavior, teaching knowledge and skills, advising about getting work published, and serving as role models and advocates. However, the survey also revealed that CTR mentors were perceived to be considerably less effective in other career aspects and particularly in promoting psychosocial personal functions. These latter aspects include facilitating professional networking, advising on negotiation for resources, preparing for career advancement, and particularly navigating work and life balance. Notably, 52% of the women and 40% of the men were “very or somewhat dissatisfied” with their work–life balance. These “softer” skills are critical to the professional and personal development of the CTR investigator and, therefore, should be emphasized in mentor training. Additionally, mentees should be trained to acquire skills to optimize the mentor–mentee relationship and navigate challenging professional and personal domains.
With the recognition of the importance of effective mentoring, there is now a substantial literature on defining mentoring competencies, mentoring outcome metrics, and best practices for developing effective mentor–mentee relations.24,25 In addition, several CTSA-funded academic health centers have recently instituted campus-wide mentor training programs, and early results are positive.30 A report from a multisite randomized controlled trial of a CTR mentor training curriculum is particularly encouraging: 15 CTSA academic health center sites and 1 non-CTSA center used a standardized competency-based research mentor training program (eight hours total) and found that both mentors and mentees reported significant perceived gains in multiple mentoring competencies.31 The success across multiple institutions suggests that this mentor training program can be adapted to each institution’s unique structure, mission, and resources. Training mentors to foster resilience and increase persistence may improve K2R transition and sustain the CTR investigator pipeline.32 Mentoring of women and junior investigators from other underrepresented groups in the biomedical research workforce can be improved by increasing awareness of more inclusive mentoring styles.33–35 We anticipate that the recently launched NIH Diversity Initiative’s National Research Mentoring Network will provide additional evidence-based guidelines for improving mentoring of the underrepresented groups.13
In conclusion, we believe that identifying, supporting, and improving the skills of mentors and mentees through competency-based training is a critical ingredient for K2R success. Furthermore, the mentor training momentum must be sustained by creating an organizational culture that values mentorship.36 This may include providing mentors with a stipend and protected time and recognizing their contributions in promotion deliberations and in institution-wide venues.27
In addition to empowering trainees through mentorship, there is increasing recognition that junior investigators can be empowered with leadership training as well.37–39 Leadership training increases emotional intelligence, negotiation and conflict management skills, teamwork, influence, coping, managing time and relations, and political acumen. For example, even though negotiations for resources, protected time, and promotion are crucial to career success, a recent study of former K awardees showed that they feel ill equipped to negotiate and view negotiation as an adversarial process.40 Empowering junior CTR investigators with these critical “soft” skills will enable them to better navigate the complex landscape of academic health centers. The challenges include the current constrained economic environment and crippling and conflicting demands on their time. Early empirical data from formal institutional leadership development programs for physicians and clinical investigators of both genders support this view.38 In addition, national women faculty career development programs are also effective,39 although they are not specifically targeted at CTR investigators.
Strategies for a durable and diverse CTR workforce will also require a culture change to recognize the importance of work–life balance and cultural diversity. This is borne out by surveys in medical and business literature. Burnout and dissatisfaction with work–life balance contribute to attrition of potentially successful CTR investigators.40,41 For example, in one single-center survey, burnout rates were approximately twice as high in faculty over 35 years of age relative to residents, and in women relative to men (22% versus 10%).41 Groups that are underrepresented in biomedical research had the highest burnout rate (30%, compared with 18% for Caucasians).
Recommendations for Future Research
There are significant gaps in our knowledge and understanding of proven best practices for ensuring the highest degree of success in K2R transition. We believe that new and improved methods for tracking this transition should be employed at a national level. In the case of CTR investigators, the CTSA national consortium is positioned to conduct further research for developing the best practices to facilitate their K2R transition.
Future research should focus on objective measures to determine and delineate the difference between essential and supplemental factors to achieving successful K2R transition. This can be done by implementing and testing existing models such as Rubio and colleagues’ comprehensive career success model.21 Further, it would be useful to conduct additional research on the aspects of mentoring that are most crucial for early investigators to move their careers forward. These studies may be difficult to conduct, particularly in the absence of prospectively defined or contemporaneous control groups. However, preliminary data on long-term follow-up of mentor development programs strongly suggest that testing this hypothesis is possible.30 The CTSA Consortium could also use its national resources to assess specific programmatic components of K award training programs that contribute to K2R success.
Future research should also examine mechanisms to improve success of women and groups that are underrepresented in biomedical research in competing for research project grants and sustaining their academic careers. Current published information regarding CTR training programs and their impacts on women and underrepresented minorities is mostly based on opinion and survey data. Additional studies are needed to identify major barriers and the methods to reduce them. Models for such programs could be developed and tracked for efficacy.
It is important to recognize that K2R is only one metric for career success and that equivalent nonfederal (e.g., foundations and industry) or U.S. Department of Veterans Affairs grant mechanisms support the careers of many successful CTR investigators. Moreover, with the emerging emphasis on interdisciplinary, team-based translational research, the paradigm is likely to shift such that a broader view of “independence” will be adopted. For example, establishing oneself as the leader of a major multi-investigator program (such as NIH’s U01 Cooperative Agreement Research Project) may evolve as a new additional benchmark for successful academic advancement. Therefore, the future metric of an individual R01 may shift, and we foresee that there will be growth in the number of co-principal investigator/project director grant applications for “independent” researchers. The promotion and tenure committees will, out of necessity, increasingly recognize and reward investigators for teamwork.
In summary, the academic literature includes many successful models for promoting transition from mentored to independent investigator status. More research will be needed to refine the mentoring practices and other proposed interventions that are most effective in this endeavor. The CTSA Consortium is well positioned to test existing models aimed at increasing the rate of K2R transition and to identify specific programmatic components of K award training programs that contribute to success. These evidence-based recommendations for promoting K2R success will be critically important for increasing, sustaining, and diversifying the pipeline for CTR investigators.
Clinical and Translational Science Award “Mentored to Independent Investigator” Working Group Committee: Daniel Beyer, Case Western Reserve University; Naomi Luban and Lisa Schwartz, Children’s National Medical Center; Henry Blumberg, Emory University (partnering with Morehouse School of Medicine and Georgia Institute of Technology); Diana Barrett, Medical University of South Carolina; Janice Gabrilove, Mount Sinai School of Medicine; Jessica Stangel, New York University School of Medicine; Michael Fleming, Northwestern University; Cynthia Morris, Oregon Health & Science University; Barry Coller and Sarah Schlesinger, the Rockefeller University; David Chaplin, the University of Alabama at Birmingham; Morris Weinberger, the University of North Carolina at Chapel Hill; Pedro Delgado, the University of Texas Health Science Center at San Antonio; Carol Sweeney, the University of Utah; Colin Depp, University of California, San Diego; Kady Nearing, University of Colorado Denver; Jack Zwanziger, University of Illinois at Chicago; James Torner, University of Iowa; Jasjit Ahluwalia and John Jodzio, University of Minnesota Twin Cities; Akshay Sood, University of New Mexico Health Sciences Center; Georgeanna Robinson, University of Pittsburgh; Bob Holloway, University of Rochester School of Medicine and Dentistry; Cecilia Patino-Sutton, University of Southern California; Robert Toto and Helen Yin, University of Texas Southwestern Medical Center; Leslie Schmitz, University of Washington; Abigail Brown and Katherine Hartman, Vanderbilt University (partnering with Meharry Medical College); My Linh Nguyen-Novotny, Weill Cornell Medical College (partnering with Hunter College); and Carol Merchant, National Center for Advancing Translational Sciences.
Acknowledgments: The authors thank their Clinical and Translational Science Award (CTSA) colleagues (Eric Beyer, MD, PhD, University of Chicago, Akshay Sood, MD, MPH, University of New Mexico, and Jack Zwanziger, PhD, University of Illinois at Chicago) for their thoughtful comments and outstanding suggestions to improve the manuscript. The authors also thank Helen Mayo, University of Texas (UT) Southwestern reference librarian, and Valerie Navarro, UT Southwestern CTSA Education Coordinator, for their contributions.
1. Alberts B, Kirschner MW, Tilghman S, Varmus H.. Rescuing U.S. biomedical research from its systemic flaws. Proc Natl Acad Sci U S A. 2014;111:5773–5777
2. Goldsmith LA.. The physician–scientist. A vanishing oxymoron? Arch Dermatol. 1992;128:474
3. Donowitz M, Germino G, Cominelli F, Anderson JM.. The attrition of young physician–scientists: Problems and potential solutions. Gastroenterology. 2007;132:477–480
4. Davis P.. The crisis in training and education a future generation of clinical investigators. Am Fed Med Res. 2010;1:28–30
6. Meyers FJ, Begg MD, Fleming M, Merchant C.. Strengthening the career development of clinical translational scientist trainees: A consensus statement of the Clinical Translational Science Award (CTSA) Research Education and Career Development Committees. Clin Transl Sci. 2012;5:123–127
7. Ambati BK, Cahoon J.. Rejuvenating clinician–scientist training. Invest Ophthalmol Vis Sci. 2014;55:1853–1855
8. Culican SM, Rupp JD, Margolis TP.. Retaining clinician–scientists: Nature versus nurture. Invest Ophthalmol Vis Sci. 2014;55:3219–3222
9. Shea JA, Stern DT, Klotman PE, et al. Career development of physician scientists: A survey of leaders in academic medicine. Am J Med. 2011;124:779–787
12. Jagsi R, Motomura AR, Griffith KA, Rangarajan S, Ubel PA.. Sex differences in attainment of independent funding by career development awardees. Ann Intern Med. 2009;151:804–811
13. Office of Strategic Coordination—The Common Fund. . The Common Fund’s Enhancing the Diversity of the NIH-Funded Workforce Program Initiative. National Insitutes of Health. http://commonfund.nih.gov/diversity/Initiatives
. Accessed September 12, 2014
14. Pohlhaus JR, Jiang H, Sutton J.. Sex differences in career development awardees’ subsequent grant attainment. Ann Intern Med. 2010;152:616–617
15. Pololi L, Cooper LA, Carr P.. Race, disadvantage and faculty experiences in academic medicine. J Gen Intern Med. 2010;25:1363–1369
16. Jones DR, Mack MJ, Patterson GA, Cohn LH.. A positive return on investment: Research funding by the Thoracic Surgery Foundation for Research and Education (TSFRE). J Thorac Cardiovasc Surg. 2011;141:1103–1106
17. Brown AM, Morrow JD, Limbird LE, et al. Centralized oversight of physician–scientist faculty development at Vanderbilt: Early outcomes. Acad Med. 2008;83:969–975
18. Goldhamer ME, Cohen AP, Bates DW, et al. Protecting an endangered species: Training physicians to conduct clinical research. Acad Med. 2009;84:439–445
19. Lee LS, Pusek SN, McCormack WT, et al. Clinical and translational scientist career success: Metrics for evaluation. Clin Transl Sci. 2012;5:400–407
20. Institute of Medicine. . The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. 2013 Washington, DC National Academic Press
21. Rubio DM, Primack BA, Switzer GE, Bryce CL, Seltzer DL, Kapoor WN.. A comprehensive career-success model for physician–scientists. Acad Med. 2011;86:1571–1576
22. Rockey SJ.. Mentoring matters for the biomedical workforce. Nature Med. 2014;20:575
23. Pfund C, House S, Spencer K, et al. A research mentor training curriculum for clinical and translational researchers. Clin Transl Sci. 2013;6:26–33
24. Fleming M, Burnham EL, Huskins WC.. Mentoring translational science investigators. JAMA. 2012;308:1981–1982
25. Silet KA, Asquith P, Fleming MF.. Survey of mentoring programs for KL2 Scholars. Clin Transl Sci. 2010;3:299–304
26. DeLong TJ, Gabarro JJ, Lees RJ.. Why mentoring matters in a hypercompetitive world. Harv Bus Rev. 2008;86:115–121, 138
27. Kashiwagi DT, Varkey P, Cook DA.. Mentoring programs for physicians in academic medicine: A systematic review. Acad Med. 2013;88:1029–1037
28. DeCastro R, Sambuco D, Ubel PA, Stewart A, Jagsi R.. Mentor networks in academic medicine: Moving beyond a dyadic conception of mentoring for junior faculty researchers. Acad Med. 2013;88:488–496
29. DeCastro R, Griffith KA, Ubel PA, Stewart A, Jagsi R.. Mentoring and the career satisfaction of male and female academic medical faculty. Acad Med. 2014;89:301–311
30. Feldman MD, Steinauer JE, Khalili M, et al. A mentor development program for clinical translational science faculty leads to sustained, improved confidence in mentoring skills. Clin Transl Sci. 2012;5:362–367
31. Pfund C, House SC, Asquith P, et al. Training mentors of clinical and translational research scholars: A randomized controlled trial. Acad Med. 2014;89:774–782
32. DeCastro R, Sambuco D, Ubel PA, Stewart A, Jagsi R.. Batting 300 is good: Perspectives of faculty researchers and their mentors on rejection, resilience, and persistence in academic medical careers. Acad Med. 2013;88:497–504
33. Bickel J.. How men can excel as mentors of women. Acad Med. 2014;89:1100–1102
34. Jeste DV, Twamley EW, Cardenas V, Lebowitz B, Reynolds CF 3rd. A call for training the trainers: Focus on mentoring to enhance diversity in mental health research. Am J Public Health. 2009;99(suppl 1):S31–S37
35. Lewellen-Williams C, Johnson VA, Deloney LA, Thomas BR, Goyol A, Henry-Tillman R.. The POD: A new model for mentoring underrepresented minority faculty. Acad Med. 2006;81:275–279
36. Steiner JF.. Promoting mentorship in translational research: Should we hope for Athena or train Mentor? Acad Med. 2014;89:702–704
37. Straus SE, Soobiah C, Levinson W.. The impact of leadership training programs on physicians in academic medical centers: A systematic review. Acad Med. 2013;88:710–723
38. Helitzer DL, Newbill SL, Morahan PS, et al. Perceptions of skill development of participants in three national career development programs for women faculty in academic medicine. Acad Med. 2014;89:896–903
39. Kupfer DJ, Schatzberg AF, Grochocinski VJ, Dunn LO, Kelley KA, O’Hara RM.. The Career Development Institute for Psychiatry: An innovative, longitudinal program for physician–scientists. Acad Psychiatry. 2009;33:313–318
40. Sambuco D, Dabrowska A, Decastro R, Stewart A, Ubel PA, Jagsi R.. Negotiation in academic medicine: Narratives of faculty researchers and their mentors. Acad Med. 2013;88:505–511
41. Primack BA, Dilmore TC, Switzer GE, et al. Burnout among early career clinical investigators. Clin Transl Sci. 2010;3:186–188