The didactic program includes four components: 1) instruction in the Responsible Conduct of Research (see section 5 below), 2) the Division of Clinical Pharmacology Didactic Series, 3) core courses from the courses Clinical Investigator Training Enhancement (CITE) program, and 4) 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 their 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 of our fellows of all the conceptual material presented and to allow time for discussion of the application of specific techniques to specific, ongoing research projects. The schedule for the Friday morning Didactic Series is presented in Appendix 1a.
CTSI-funded Clinical Investigator Training Enhancement (CITE) program (Masters of Science in Clinical research) (formerly K30 funded) organized by Kurt Kroenke MD (see letter of collaboration with Letters of Support) provides a platform for many core courses applicable to translational research in any discipline of medicine. Fellows in our program are also given the opportunity to participate in the CITE program in its entirety; however, given the course work requirements for this Master's in Science program, three years are required to complete our Pediatric Clinical Pharmacology training program for those who choose to complete the CITE program concurrently. Three courses from the CITE curriculum are required of all of our fellows. Dr. Kroenke has organized outstanding courses in Research Methods and Clinical Trials. One of these courses is offered each semester (fall and spring) of the year. The courses each meet for three hours per week (12-1:30 p.m.) and provide an excellent introduction to the nuts and bolts of clinical and translational research. The faculty members of the program proposed in this application believe that these particular courses are of such importance in the development of our pediatric clinical pharmacology trainees that we have chosen to require them of our fellows. Syllabi for these courses are provided in Appendices 1c and 1d.
Fellows are also required to take a course in biostatistics to ensure that they have a foundation upon which to base their analyses of results from their research, journal club articles and clinical trials reported in the literature; and to provide them a foundation of skills to design and power both large and small clinical trials. As such, fellows are required to take the biostatistics course that is integral to the CITE program. In addition to this formal coursework, training in statistics within the School of Medicine is not provided by isolated individuals, but by an organized program within a Division of the Department of Medicine that has ten faculty members: the Division of Biostatistics. This arrangement allows all researchers and trainees access to a broad range of statistical sophistication, and 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 organized by Juan Lertora, M.D. from the NIH Clinical Center in Bethesda. This course forms the basis of the most recent textbook in Clinical Pharmacology and serves as a broad overview of topics in Clinical Pharmacology that provides our fellows breadth of exposure to the field. It is taught by faculty members from the National Institutes of Health and guest faculty from the Food and Drug Administration (FDA), the pharmaceutical industry, and several academic institutions from across the United States.