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Clinical Research Core - Clinical Trials Development

Michael J. Keating, M.D., B.S.
M.D. Anderson Cancer Center

William Wierda M.D., Ph.D.
M.D. Anderson Cancer Center

Kanti R. Rai, M.D.
Long Island Jewish Medical Center

Neil Kay, M.D.
Mayo Clinic

Dana Farber Cancer Institute

Research-Based Objectives

  1. Clinical trial development linked with correlative studies. Design, data collection, and analyses of new protocols developed by CRC investigators will be fully supported.
  2. Develop predictive models, identify, and confirm prognostic factors for clinical endpoints including time to treatment, response to treatment, time to progression, and survival.
  3. Develop systems for data exchange between different databases in order to increase access to available clinical data.

Core-Based Objectives

  1. Further develop CIMS and patient database(s) to assure complete and accurate clinical and laboratory data.
  2. Provide a clinical trial-specific structure to utilize CIMS for CRC clinical trials.
  3. Provide a platform in which CRC investigators performing laboratory studies interface with Biostatistics Core B to request clinical information for analyses.
  4. Coordinate CRC Clinical Advisory Committee (CAC) activities.
  5. Maintain and coordinate regulatory documentation including IRB correspondence, SAE reports, FDA correspondence and audit results for CRC clinical sites.
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