The clinical core has the responsibility of implementation and close monitoring of the clinical trials investigating the effectiveness of dendritic cell (DC) immunotherapy for metastatic melanoma as outlined in the specific aims of investigators at the Baylor Institute for Immunology Research. The functions of the Clinical Core are divided into four general areas: (1) Performance of clinical trials involving patients with metastatic melanoma with the highest level of good clinical practice; (2) Implementation of clinical research after approval by the Institutional Review Board (IRB) of the Baylor University Medical Center (BUMC), the National Cancer Institute (NCI) and the United States Federal Drug Administration (FDA); (3) Write, implement and update as necessary a clinical trial monitoring policy as mandated by the Baylor Research Institute (BRI) in Dallas and the FDA in collaboration with our outside clinical protocol monitors to promote accurate collection of clinical and laboratory research data, prompt and comprehensive reporting of adverse events as a result of patient participation in clinical research to the IRB,NCI and FDA and to ensure patient safety; (4) Operate and oversee the apheresis center at BUMC to ensure patient safety and proper collection of autologous mononuclear cells for DC vaccine design; (5) Maintain high quality records of patient participation and document regulatory activities of the clinical research in collaboration with the DC Core in a manner acceptable to the IRB,NCI and FDA. The core will be responsible for the integrity of the clinical outcomes of the research. We have established a Data Safety and Monitoring Board (DSMB) and a Melanoma Trials Overview Committee (MTOC) as oversight entities.
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