This proposal constitutes the renewal application of the Pediatric Oncology Clinical Research Training Program (POCRTP), developed by Baylor College of Medicine's Texas Children's Cancer Center. This training program is predicated on the premise that 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 renewal application highlights the impressive academic accomplishments and progress of the individual trainees recruited during the last five years. The program is structured to provide a formal, comprehensive, multidisciplinary clinical research educational program that trains (1) pediatricians who have completed a three-year pediatric hematology-oncology fellowship training program and are board eligible in that subspecialty and, (2) Ph.D. nurses with a career interest in pediatric oncology clinical research. Trainees, in this """"""""one-track"""""""" program, designated """"""""Paul Calabresi Scholars"""""""", receive comprehensive didactic training and a mentored training experience in the design, implementation, conduct and analysis of clinical research trials. The program emphasizes training in therapeutic research that occurs in team research settings in which basic and clinical scientists interact to expedite the translation of basic research discoveries into patient-oriented therapeutic cancer research. The program includes participation in a core didactic course in clinical investigation and trial design, provided through Baylor College of Medicine's Clinical Scientist Training Program, and an in-depth clinical research training experience focused in one of five specialized research areas, designated """"""""Pathways"""""""", chosen by the trainee. The POCRTP Pathways include clinical pharmacology, neuro-oncology, cell and gene therapy, leukemia or solid tumors. The research experience within each Pathway is tailored to meet the individual trainee's long- term research goals. All trainees receive comprehensive mentorship by both a laboratory research and a clinical research mentor and receive in depth instruction in clinical trial design, statistical analysis, research ethics and regulatory requirements and guidelines. In addition, trainees design and conduct clinical trials in their respective Pathways. In this renewal period, an elective rotation at the National Cancer Institute's Cancer Therapy Evaluation Program has been added. The experience to date indicates that trainees who complete this program are exceptionally well trained in clinical research, very successful in obtaining NIH funding and well positioned to become future leaders in pediatric oncology clinical research.
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