Purpose & Objectives

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A two to three year formal, comprehensive, multidisciplinary clinical research educational program for M.D.s and Ph.D.-prepared oncology nurses focusing on the design, implementation and analysis of all phases of clinical research trials. Trainees will receive in-depth education through a core clinical research curriculum (through the Clinical Scientist Training Program) and participation in clinical research training in one of five specialized training tracks:

Clinical Pharmacology Research Track Objectives
Neuro-Oncology Clinical Research Track Objectives
Cell and Gene Therapy Clinical Research Track Objectives
Leukemia Clinical Research Track Objectives
Solid Tumor Clinical Research Track Objectives

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.
  • 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.

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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.

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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.
  • To examine the use of gene therapy through the use of bone marrow and stem cells.
  • To review specific regulatory and ethical considerations related to cell and gene therapy.

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Leukemia Clinical Research Track Objectives:

  • To develop expertise in the design and implementation of clinical research trials for children with acute and chronic leukemias, including diagnosis, therapy, and management of acute and chronic complications and care of long-term survivors.
  • To develop proficiency in laboratory skills and data analysis as they pertain to treatment of children with leukemia.
  • To develop expertise in the special requirements of clinical and pharmacologic studies of new anticancer agents for the treatment of leukemia.
  • To interact with COG in order to understand the development of multi-institutional clinical trials in leukemia.
  • To explore clinically applicable laboratory research in areas pertinent to leukemia.
  • To understand the ethical and regulatory issues involved in leukemia biology research, including special protections afforded to children, appropriate recruitment of minorities into clinical trials, and the role of the Institutional Review Board.

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Solid Tumor 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 solid tumors.
  • To develop expertise in the fundamentals of the treatment of solid tumors.
  • To develop knowledge regarding a current understanding of the molecular events involved in the development of solid tumors.
  • 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 research, including special protections afforded to children, appropriate recruitment of minorities into clinical trials, and the role of the Institutional Review Board.

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Page modified on November 22, 2021