TRAINING PROGRAM IN HUMAN INVESTIGATION

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DESCRIPTION (Applicant's Abstract) Clinical investigators are disappearing from the ranks of federally funded research portfolios to the extent that they have become an "endangered species". To counter this loss, the goal of this proposed Master's program at Thomas Jefferson University is to prepare investigators for enduring careers pursuing funded, hypothesis-driven patient-oriented research and to be role models and mentors to subsequent investigators pursing similar careers. This proposal presents a Clinical Research Curriculum composed of a multi- disciplinary faculty with expertise in patient-oriented research, an expanded existing core of relevant courses and patient-based research experiences, and mentored training in clinical investigation. Successful completion of the proposed program will require greater than 40 course credits and a formal research thesis and defense. Applications initially will be solicited from a large pool ((greater than 650) of trainees drawn from the different colleges within the university. Eligible applicants will include house officers and subspeciality fellows, dentists, pharmacy fellows with a Pharm.D., Ph.D. fellows, and those with doctoral degree in nursing interested in patient- oriented research. Applicants will submit a written application, three letters of recommendation, and transcripts and will be selected by an Advisory Committee following personal interviews. Once accepted, trainees will pursue a unique program of didactic and applied research components. Formal coursework will provide training in essential topics for patient-oriented research including biostatistics, epidemiology, clinical trial design, outcomes research, bioethics and the responsible conduct of research, clinical pharmacology, federal policy and regulations on human subjects, and scientific writing. Coursework will be supplemented with components that provide practical experience central to the conduct of patient-oriented research. These will include (1) a clerkship in the Jefferson Clinical Research Unit in which trainees will participate in a mentored clinical research experience by generating, implementing, completing, and reporting on a randomized clinical trial; and (2) identification of an interest-specific thesis question and advisory, development of a thesis proposal, and conduct of thesis research. Additional novel aspects of this training program include rotations on the Institutional Review Board (IRB) and Cancer Clinical Research Review Committee (CCRRC) and a clerkship in the critical review of scientific literature with the editorial staff of the Annals of Internal Medicine. Other important programmatic components will include ethics seminars and conferences, journal club in clinical investigation, an in-house research seminar series, and seminars in clinical investigation with invited speakers from outside the institution. Upon completion of the program, trainees will have (1) a thorough understanding of hypothesis formulation and testing in patient-based studies, (2) a theoretical foundation and working knowledge of research designs, (3) insight into the integration of laboratory-based analyses and surrogate endpoints in patient-oriented research, (4) a demonstrated record of achievement conducting randomized clinical trials and other types of studies documented through publication, (5) the ability to critically evaluate the scientific literature, and (6) the ability to employ various computer-based statistical and database packages in research-related problems. Upon completion of the program, trainees will be qualified to perform independent clinical research with certification through a Master's of Science in Human Investigation.