The Department of Pharmacology and Experimental Therapeutics has offered an NIH-sponsored fellowship program in Clinical Pharmacology since 1995. A dedicated track in Pediatric Clinical Pharmacology was established in 2010 in conjunction with A.I Dupont Hospital for Children. The program is accredited by the American Board of Clinical Pharmacology. Graduates of the program have assumed leadership positions in academic medicine, the Food and Drug Administration, and industrial drug development.
Introduction. Thomas Jefferson University has established a training program in clinical pharmacology and clinical research that integrates formal didactic training in basic and clinical pharmacology and research methodologies with hands-on experience in laboratory research and human clinical trials. The overall goals of the program are to integrate training in the general methodologies, concepts, and approaches of basic and clinical pharmacology and in hypothesis-driven basic and clinical research to produce investigators who can establish competitive basic, translational, and/or clinical research programs and bridge the gap between the laboratory and the patient. Programs are individually tailored to the trainee's professional interests and goals. The expected duration of training is two or three years.
Qualifications of Accepted Trainees. The program is focused on training investigators in basic and clinical research to enable them to assume leadership positions in academic centers, the pharmaceutical industry, or in governmental regulatory agencies. Requirements for admission include two to three years of clinical postgraduate training for M.D. applicants. Priority is typically given to those who are board eligible in their primary specialty. Ph.D. and Pharm.D. applicants are evaluated on the basis of their thesis research and research interest area(s), and career goals as they relate to a clinically-oriented pharmacology research project.
Distribution of Trainees' Effort. Most (>80%) of the trainees' time during the first 2 years of fellowship is devoted to research. Trainees usually select a project during the first 3 months of fellowship. The trainee is expected to design and execute at least one clinical investigation and, thereby, gain expertise in clinical pharmacology and clinical trial methodologies including principles of study design, and pharmacokinetic and pharmacodynamic analysis and interpretation.
Trainee Guidance and Evaluation. Overall guidance and evaluation of performance is the responsibility of the Program Director. Fellows receive training in the form of a recommended curriculum and required journal club, case conferences, research seminars, and seminars in clinical pharmacology. These didactic and clinical experiences continue through at least 2 years of the training program. Fellows determine which laboratory their primary research training will occur in consultation with the Program Director. Specific preceptors are responsible for evaluating research progress while the Program Director regularly meets with fellows to assess progress.
Expectations of Fellows Completing the Program. The overall goals of the program are to impart to the trainee the requisite expertise in the concepts, approaches, and techniques of clinical pharmacology and basic and clinical research to facilitate their development as independent investigators in the areas of drug discovery and development. Specifically, it is anticipated that fellows completing the program will have:
- Designed, implemented and analyzed at least one clinical study of sufficient scientific rigor to result in presentation at a national meeting and a publication in peer-reviewed journal;
- Designed, implemented and analyzed an original laboratory-based research project in basic or translational pharmacology of sufficient scientific rigor to result in presentation at national meeting and publication in a peer-reviewed journal;
- Fulfilled the requirements for subspecialty board eligibility in clinical pharmacology. Specifically, it is a goal of the program that M.D. fellows obtain dual certification, one in their primary specialty, e.g., internal medicine (ABIM), and one in clinical pharmacology (ABCP). Non-M.D. fellows (Ph.D.'s or Pharm.D.'s) will be expected to obtain certification in applied pharmacology (ABCP).
- Demonstrated expertise in evaluating complex therapeutic issues in patients. Primary authorship of a scientifically rigorous case report and/or review of a selected therapeutic area will demonstrate expertise.
- Become active members in one of the clinical pharmacology professional societies, including the American Society for Clinical Pharmacology and Therapeutics (ASCPT) and/or the American College of Clinical Pharmacology (ACCP). Participation in, and contribution to the scientific sessions of the annual meetings of those societies will demonstrate active membership.
Upon completion of their training, it is expected that fellows will be qualified for positions in academic clinical pharmacology divisions, other academic departments, the pharmaceutical industry, and at the FDA.
Application Procedure. Inquiries or applications are invited from qualified individuals. Interested individuals should forward a letter outlining their intent to obtain training in clinical pharmacology and/or clinical research and a statement of career goals; 3 letters of recommendation including, where appropriate, letters from graduate advisors, program directors, and supervisors; medical school transcripts and diplomas and certificates of completion of clinical or professional training; and professional certification exam scores to: Training Programs In Clinical Pharmacology Thomas Jefferson University 132 South 10th Street, 1170 Main Philadelphia, PA 19107