A critical need exists for a robust supply of clinician scientists with formal training in pediatric clinical pharmacology. Without trained investigators the goal of optimizing use of medications for individual children cannot be realized. The Indiana University Department of Pediatrics and Division of Clinical Pharmacology are uniquely positioned to address this need. A strong, well-established group of clinical pharmacology investigators has the advantage of being located directly adjacent to one of the strongest pediatric research environments in the US: Riley Hospital for Children, with a Department of Pediatrics consistently ranked in the top 10 in NIH funding. This application seeks to establish a formal pediatric clinical pharmacology and therapeutics training program in parallel with our long-standing clinical pharmacology training program, which has a track record of excellence in training successful translational clinician scientists. There are three main components to the Indiana University Postdoctoral Research Training in Pediatric Clinical and Developmental Pharmacology: 1) completion of a two to three year formal didactic curriculum, at the end of which the trainee may receive a master's degree in clinical research;2) organized pediatric participation in a personalized therapeutics seminar series and weekly journal club;and 3) active involvement in pediatric therapeutics research under the mentorship of one of the faculty members associated with the program. The program faculty selects trainees for the 2 to 3 year program based on their potential as clinician scientists from candidates with MD or MD/ PhD degrees who qualify for primary specialty certification. Exceptional PhD or PharmD candidates with experience and goals related to the objectives of the program may be selected. We propose supporting a total of three postdoctoral fellows at any given time. Those who complete the program will develop core competencies in clinical and translational research methods, biostatistics, clinical trials, research ethics, scientific writing, and grant writing. They will also be provided with a structured research mentoring program with an explicit timeline and benchmarks. In depth training focusing on pharmacokinetics, pharmacogenomics, drug development, individualized therapeutics, and clinical trial design is included in a didactic lecture series required of all trainees. Trainees may also participate in the Clinical Investigator Training Enhancement program supported by the Indiana CTSI and resulting in an MS in Clinical Investigation. Coursework combined with supervised research experience will result in development of a highly trained cadre of investigators with broad, deep, cutting edge training experiences preparing them for successful careers in pediatric clinical and translational pharmacology. The large, diverse patient population at Riley Hospital coupled with the depth, breadth and flexibility imparted by a large, cutting edge Clinical Pharmacology training program and the Wells Center for Pediatric Research offer an exceptional opportunity to study pediatric clinical pharmacology within a focused training program designed to generate leaders in this emerging field.

Public Health Relevance

The Indiana University Postdoctoral Research Training in Pediatric Clinical and Developmental Pharmacology proposed in this application is located in an ideal environment with a well-established Division of Clinical Pharmacology and a large, free-standing pediatric hospital with multiple funded investigators. We expect that the synergy created by this partnership will generate leaders in the field of pediatric clinical pharmacology.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Institutional National Research Service Award (T32)
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Special Emphasis Panel (ZHD1-DSR-K (05))
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Giacoia, George
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Indiana University-Purdue University at Indianapolis
Schools of Medicine
United States
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