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Pediatric Clinical Pharmacology Fellowship

IU School of Medicine Department of Medicine Division of Clinical Pharmacology partners with the Department of Pediatrics to support the training of pediatric clinical pharmacology physicians with a strong group of well-established clinical pharmacology investigators. Training for this program is occurs on the IU School of Medicine – Indianapolis campus, directly adjacent to one of the strongest pediatric research environments in the United States: Riley Hospital for Children at IU Health. The Department of Pediatrics at IU School of Medicine is consistently ranked in the Top 10 for NIH funding.

The three main components of the Pediatric Clinical Pharmacology Fellowship include active involvement in pediatric therapeutics research under the mentorship of one of the faculty members associated with the program; organized pediatric participation in a personalized therapeutics seminar series and weekly journal club; and completion of a two- to- three year formal didactic curriculum. At the end of this program, the trainee may receive a master’s degree in clinical research.

Those who complete the program develop core competencies in clinical and translational research methods, biostatistics, clinical trials, research ethics, scientific writing and grant writing. Fellows are also provided 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 for all fellows.

The large, diverse patient population at Riley Hospital for Children—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.

Didactics

The didactic program for the Pediatric Clinical Pharmacology Fellowship includes four components: instruction in the responsible conduct of research; the Division of Clinical Pharmacology Didactic Series; core courses from the Clinical Investigator Training Enhancement (CITE) program; and the NIH web-based course, Principles in Clinical Pharmacology. This coursework is designed to provide a formal approach to teaching the basic skills necessary to be a successful pediatric clinical pharmacology researcher. They provide the knowledge base to facilitate trainees to be active participants in the other components of their training program including the seminar and journal club discussions and research.

The Division of Clinical Pharmacology Didactic Series is a comprehensive, two-year cycle of presentations in which basic pharmacokinetic, pharmacogenetics and biostatistics courses are presented in the first year, and sessions that have an emphasis on drug development and the individualization of therapy are presented in the second year. Sessions on bioethics are included throughout the cycle. This class is structured as a discussion group which may last from one- to- three hours in order to ensure a full understanding by all fellows of the conceptual material presented and to allow time for discussion of the application of specific techniques to ongoing research projects.

Fellowship Training Components

Pediatric Clinical Pharmacology fellows may participate in the Clinical Investigator Training Enhancement program supported by the Indiana CTSI, which results in a master’s degree in clinical investigation. The CITE program provides a platform for many core courses applicable to translational research in any discipline of medicine. Fellows within the program are given the opportunity to participate in the CITE program in its entirety; however, given the coursework requirements for the Master’s in Science program, three years are required to complete the Pediatric Clinical Pharmacology Fellowship Program for those who choose to complete the CITE program concurrently. Three courses from the CITE curriculum are required of all fellows. These courses meet for three hours per week and provide an excellent introduction to the foundation of clinical and translational research.

Pediatric Clinical Pharmacology fellows are required to take a course in biostatistics to ensure they have a solid foundation upon which to base their analyses of results from their research, journal club articles and clinical trials reported in literature. The course also provides a foundation of skills to design and power both large and small clinical trials. In addition to formal coursework, training in statistics within IU School of Medicine is not provided by isolated individuals but by an organized program within the Department of Biostatistics. This arrangement allows all researchers and trainees access to a broad range of statistical sophistication in order to calibrate their training according to their needs.

The weekly training curriculum is rounded out on Thursday evenings by mandatory attendance at a live video-conferencing presentation of the Principles in Clinical Pharmacology course. This course forms the basis of the most recent text in clinical pharmacology and serves as a broad overview of topics that provides fellows breadth of exposure to the field. This course is taught by NIH faculty members and guest faculty from the Food and Drug Administration (FDA), the pharmaceutical industry, and several academic institutions from across the United States.