KL2-Mentored Clinical and Translational Research Scholars Program

Purpose

The goal of the ACTSI KL2-Mentored Clinical and Translational Research Scholars program is to support and enhance career development for junior faculty (MD, PhD, MD/PhD, or PharmD) from a wide variety of disciplines at Emory University, Morehouse School of Medicine (MSM), Georgia Institute of Technology (Georgia Tech), and University of Georgia (UGA) College of Pharmacy. The ACTSI KL2 Core is committed to assisting junior faculty at partner institutions to become independent, established, and ethical clinical and/or translational research investigators. Trainees accepted into the KL2 Scholars program will receive salary support to enable them to spend at least 75% of their professional time (50% is allowed for trainees from surgery or surgical subspecialties) on clinical and/or translational research and research training and a $25,000 technical budget for research-related expenses and tuition for the Master of Science in Clinical Research (MSCR) degree or Certificate Program in Translational Research (CPTR) curriculum. Didactic research training is provided through the required MSCR or CPTR programs and mentored research training under the direction of an established, federally-funded clinical investigator at one of the collaborating institutions. Support in the program will be provided for up to two years and is based on performance in the program.

The KL2 program provides the opportunity to build upon the resources of the ACTSI and other established programs in supporting junior faculty members who want to establish a successful clinical and/or translational research career. The KL2 program provides the opportunity for didactic training (in large part through the MSCR or CPTR programs) and also requires that the trainee have an established and successful lead mentor (as well as an Advisory Committee) who could provide further guidance and training for those pursuing careers in clinical and/or translational investigation.

Background

The KL2 program responds to national efforts to support the training and development of junior faculty members who will become well trained, successful, and independent clinical and/or translational investigators. The KL2 program builds on the considerable strengths and outstanding resources in Atlanta and at Emory, MSM, Georgia Tech, and UGA.

The ACTSI KL2 addresses the recommendations of the National Academy of Medicine and others about the need to intensify efforts to train and retain clinical and translational researchers in order to reverse the dramatic decline of clinical and/or translational investigators entering the research workforce. The rationale for the education and training program includes the expanding need for high-quality clinical and translational research; the necessity for integration of the analytic sciences and clinical and translational research; the need to translate research findings from the bench to the bedside and from the bedside to the community; the importance of interdisciplinary education and training in clinical and translational research; and the extensive expertise in and record of clinical investigation represented by the faculty at the collaborating institutions (i.e., Emory, MSM, Georgia Tech, and UGA).

The MSCR or CPTR programs at either Emory or MSM provide didactic training for those applicants from the respective institutions accepted into the KL2 program. All applicants accepted into the ACTSI KL2 program will be required to enroll in the MSCR program (either at Emory or MSM) or CPTR, although students can take courses in either program and there are some joint courses. The Emory MSCR program is offered by the James T. Laney School of Graduate Studies.

The Emory MSCR program requires a minimum of 30 hours of academic credit that include in-class didactic coursework and a written research thesis. Generally, three semesters of didactic study (10-12 months minimum for full-time students) are required and an optimal time of 18-24 months to complete the program (including the mentored thesis). For most investigators, the period of two years is appropriate to accomplish both the didactic work (one year) and completion of an appropriate investigative research thesis.

The MSM MSCR program is a broad-based multidisciplinary graduate level program in clinical and translational research designed to address the problem of health disparities and the shortage of clinical and translational researchers through a concerted effort to recruit and train doctoral prepared minority candidates for successful careers in clinical and translational research.  The program provides training in the principles and methods of biostatistics, epidemiology, including genetics and clinical trials, big data and informatics, and outcomes research, including health services research, patient centered outcomes research methods and community engagement.

Additional Information

An investigator initiated, hypothesis driven proposal with specific aims will be developed by each trainee. The research proposal must have a “human component,” i.e. interaction with human subjects or specimens obtained from identifiable humans. This will be initially outlined in the application submitted by candidates for the program and will be further refined after enrollment in the KL2 program. If the KL2 scholar’s research project involves a clinical trial, per NIH rules, ONLY clinical trials through the end of Phase IIA are eligible. Progress towards those aims will be updated in required semi-annual reports. It is anticipated that the clinical or translational research project that the trainee is working on under the guidance of their lead mentor will provide the data to be analyzed for their mentored thesis, which is required for those enrolled in the MSCR degree program. Clinical and/or translational research will begin during the first year of the KL2 program. Much of the KL2 scholar’s time in the first year will be devoted to didactic research trainings (e.g., first year of MSCR curriculum). In the second year of the KL2 program, a large portion of the KL2 scholar’s time will be devoted to working on their clinical and/or translational research project, under the guidance of their mentor and completing the MSCR written thesis for those enrolled in the MSCR degree program. The KL2 scholar’s thesis research must be presented to the ACTSI Research Education Executive Committee and the mentoring team at a session scheduled before the final written thesis is submitted to the Graduate School. The KL2 program will provide additional support as well through ongoing functions such as journal club, colloquiums, and special seminars (often in collaboration with the MSCR program or other ACTSI components). Other KL2 scholar’s career development research training activities include leadership training, Science of Team Science training, and mentorship training. The importance of interdisciplinary research will be emphasized in these additional colloquiums and seminars. Each KL2 scholar accepted into the ACTSI KL2 program must submit a mandatory NIH K23 Mentored Patient-Oriented Research Career Development Award or equivalent NIH K award (e.g. K01, K08) grant application by the end of their first 12 months of KL2 funding.

Acknowledgements

All publications derived from work supported by the KL2 award must acknowledge the ACTSI KL2-Mentored Clinical and Translational Research Program and NIH KL2 support (KL2TR000455).

Contact

Igho Ofotokun, MD, MS

Alexander Quarshie, MD

Somanath P.R. Shenoy, PhD,FAHA