Thomas Jefferson University and the Children’s Hospital of Philadelphia offer a joint NIH-sponsored fellowship training program in Clinical Pharmacology. This program focuses on the core principles of clinical pharmacology across the developmental continuum from pediatric to adult populations. The program is accredited by the American Board of Clinical Pharmacology (ABCP). Graduates of the program have assumed leadership positions in academic medicine, the Food and Drug Administration, and industrial drug development.

The Thomas Jefferson University and Children’s Hospital of Philadelphia joint training program in adult and pediatric clinical pharmacology integrates formal didactic training in basic and clinical pharmacology and translational research methodologies with hands-on experience in laboratory research and human clinical trials. The overall goals of the program are to integrate training in methodologies, concepts, and approaches of basic and clinical pharmacology across the developmental continuum and in hypothesis-driven basic and clinical research. The program seeks to produce investigators who can establish competitive basic, translational, and/or clinical research programs and bridge the gap between the laboratory and the patient, as well as between children and adults. 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 clinician investigators in basic and clinical research to enable them to assume leadership positions in academic centers, the pharmaceutical industry, or in the Food and Drug Administration (FDA). 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 (e.g., Medicine, Pediatrics). Pharm.D. or other allied health-trained 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. Trainees are 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 & Evaluation

Overall guidance and evaluation of performance is the responsibility of the Program Directors. Fellows receive training in the form of a recommended curriculum and required journal club, case conferences, research seminars, and seminars in clinical pharmacology. Pharmacokinetic instruction is provided, with the option for advanced pharmacometric training. Didactic and clinical experiences continue through at least 2 years of the training program and are conducted at both Thomas Jefferson University and the Children’s Hospital of Philadelphia. Fellows identify laboratories for their primary research training in consultation with Program Directors. Specific preceptors are responsible for evaluating research progress while Program Directors meet monthly with fellows to assess progress. Individualized 2-3 month rotations are available at the FDA or within large pharmaceutical industrial partners.

Expectations of Fellows Completing the Program

The overall goals of the program are to impart to trainees the requisite expertise in the concepts, approaches, and techniques of clinical pharmacology and basic and clinical research in adult and pediatric populations to facilitate their progression to independence as 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., Medicine or Pediatrics, 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).
• 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 (e.g., Medicine, Pediatrics), the pharmaceutical industry, or at the FDA.