Core B: Clinical Trials Core

PROJECT SUMMARY/ABSTRACT (CLINICAL TRIALS CORE) The University of Michigan Rogel Cancer Center Molecularly Targeted Radiosensitization of Locally Advanced Cancers SPORE aims to reduce mortality for multiple types of cancer through bringing basic science research to the patient in a rapid, efficient and scientifically rigorous approach. For research discoveries to move smoothly and efficiently into clinical trials, there needs to be a coordinated infrastructure with a focus on the translational outcome. The Clinical Trials (CT) Core will augment services provided by the University of Michigan (UM) Rogel Cancer Center’s Oncology-Clinical Trials Support Unit (O-CTSU) and the University of Michigan IND/IDE Investigator Assistance Program to provide a seamless infrastructure to facilitate the rapid and efficient development, initiation and completion of clinical trials assuring all trials meet Good Clinical Practice (GCP) and adhere to rigorous scientific principles. The CT Core will be a lean core and not duplicate effort provided by the Cancer Center and UM. The CT Core will be staffed by a Radiation Oncology Director and Medical Oncology Director, Clinical Research Project Manager and Clinical Research Coordinator. The CT Core staff will support all aspects of clinical trials implementation and conduct including protocol development and approval by regulatory entities, protocol activation, participant identification, recruitment, informed consent process, monitoring for adverse events, data and biosample collection and handling, and reporting of study results. The CT Core will collaborate with the O-CTSU to manage regulatory aspects and data entry for SPORE clinical trials. SPORE clinical trials will undergo auditing and monitoring by the Cancer Center’s Quality Assurance and Review Committee (QARC) and findings will be reviewed by the CT Core Director and the Cancer Center’s Data and Safety Monitoring Committee (DCMC). The CT Core Directors will meet monthly with the SPORE clinical trial Principal Investigators to ensure communication, optimize usage of Core resources, and review progress on development, implementation and conduct of SPORE clinical trials. The Directors and staff will mentor and educate all investigators on GCP for clinical research, especially the applicants and awardees of the Career Enhancement Program (CEP). The Directors will review progress on analysis of trial results with trial Principal Investigators, the Biostatistics and Computational Biology (BCB) Core and Translational Pathology (TP) Core to ensure timely publication of SPORE trials results.