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Faculty Fellowship in Pediatric Oncology Clinical Research

by Akane Naka, Project Manager | January 09, 2007

Clinical Pharmacology Research Track Objectives:
* To develop expertise in clinical research methodology with specific emphasis on the design, proper conduct, and analysis of phase I and II pharmacokinetic studies of new anticancer agents.
* To develop proficiency in laboratory and data analysis skills as they pertain to pharmacokinetic and other correlative studies.
* To develop expertise in the special requirements of clinical and pharmacologic studies of new anticancer agents in infants, children and adolescents.
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* To acquire in-depth knowledge of the basic principles of the pharmacology of anticancer drugs.
* To interact with COG, pharmaceutical companies, and regulatory bodies in order to acquire an understanding of the roles of national organizations, cooperative groups, sponsors, regulatory bodies, and clinicians during the drug development process.
* To understand the ethical and regulatory issues involved in pediatric drug research, including special protections afforded to children, appropriate recruitment of minorities into clinical trials, and the role of the Institutional Review Board.

Neuro-Oncology Clinical Research Track Objectives:
* To develop expertise in clinical research methodology with specific emphasis on the design and proper conduct of phase I, II, and III clinical studies as they pertain to children with CNS tumors.
* To develop expertise in the fundamentals of treatment for CNS tumors.
* To develop an understanding of the molecular events involved in the development of CNS neoplasms.
* To gain expertise in the development of correlative studies that incorporate new diagnostic technologies, neuroimaging techniques, and treatment modalities.
* To understand the ethical and regulatory issues involved in pediatric clinical research, including special protections afforded to children, appropriate recruitment of minorities into clinical trials, and the role of the Institutional Review Board.

Cell and Gene Therapy Clinical Research Track Objectives:
* To develop expertise in clinical research methodology with specific emphasis on gene identification, expression and regulation, and target cell identification.
* To examine methods for gene delivery, including retroviral, lentiviral, adenoviral, other DNA viruses, and non-viral vectors.
* To review tissue-specific perspectives for gene delivery.
* To understand the specifics of cancer gene therapy.
* To evaluate the essential components related to vaccine therapy.