The development of pediatric oncologists and pediatric oncology nurses who are highly trained in clinical research is essential for continued progress to be made in the treatment of childhood cancer. This proposal describes a Pediatric Oncology Clinical Research Training Program, developed by Baylor College of Medicine's Texas Children's Cancer Center, that is structured to provide a formal, comprehensive, multidisciplinary clinical research educational program that will train board eligible pediatric oncologists who have completed a three year fellowship and Ph.D.-prepared ontology nurses in the design, implementation and analysis of all phases of clinical research trials. Trainees will spend a portion of their first year participating in a core curriculum in clinical research and spend the remainder of that and subsequent year(s) receiving further clinical research training in their choice of one of five specialized training tracks (clinical pharmacology, neuro-oncology cell and gene therapy, leukemia or solid tumors). This carefully mentored training program will take advantage of BCM's funded (NIH-K30 award) Clinical Scientist Training Program to provide a comprehensive, didactic clinical research core curriculum that will serve as a foundation for further training within one of the five specialized areas of research. The research experience within each of these areas will be tailored to meet the individual trainee's long-term research goals. It will provide mentorship by both a laboratory and clinical mentor' while providing in depth exposure to the most important facets of the clinical research process. Trainees will be instructed in clinical trial design, statistical analysis, research ethics and regulatory requirements and guidelines. In addition, under the tutelage of experienced mentors, trainees will design and conduct clinical trials in their respective areas of focus and will learn by mentor modeling the uniquely interactive, collaborative skills necessary to successfully develop effective clinical trials. Because trainees who complete this program will be well-grounded in both in the basic biology of their particular specialty areas and translational research skills, they will be well suited to become future leaders in pediatric oncology clinical research.
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