Clinical Trial Operations

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The Clinical Trial Operations Core will provide the leadership and expertise needed to support the clinical research of the four Projects of this SPORE grant. The Clinical Trial Operations Core will be Co-Directed by Dr. Annick Desjardins and Dr. Darell Bigner. Dr. Desjardins will interact with Project leaders to develop clinical trials based upon the data generated from laboratory investigations. The Clinical Trial Operations Core will support the actual conduct of SPORE clinical trials, including providing clinicians, research manager, research nurses, research nurse practitioner, clinical trial coordinators, regulatory personnel and data coordinators. Drs. Desjardins and Bigner will assure the development, successful conduct, and publication of the clinical trials coming from the work of the four Projects by assuring the development of all the required documents for the conduct of the study (e.g., protocols, consent forms, clinical side of IND submission, standard operating procedures, regulatory management, data collection, and data publication). Core B, biostatistical component, will provide advice on the design of experimental and clinical studies, including calculating sample sizes and power; data analysis support (either by performing the analyses within the core or advising qualified personnel within the projects), including the use of appropriate statistical models and applications of statistical test; and, when necessary, the development of novel methods to help interpret results from experiments. Additionally, a member of the biostatistical component will participate in regularly scheduled project meetings to provide statistical/bioinformatics input and assist in preparing the necessary materials for presentation and publication.