The Case CCC is committed to the clinical development of novel concepts through early phase clinical investigation. A long track record of successful translation of 'home-grown'scientific concepts has been facilitated by Protocol Specific Research Support (PSRS), and we continue our focus on investigator initiated, innovative, feasibility and Phase 1 clinical research protocols that contain laboratory correlates to advance the science of therapeutic discovery. PSRS is overseen by the Case CCC Clinical Research Office (CRO), which coordinates the activities of the Clinical Trials Core Facility (CTCF), Protocol Review and Monitoring Committee (PRMC), Data and Safety Monitoring, and Protocol Specific Research Support. The Case CCC has a robust infrastructure for early drug development, with consortium member institutional support in addition to a U01 (Dowlati, PI 5U01CA062502-18, Phase I Emphasis) grant and a NOI (Villalona, Consortium Pl, HHSN261201100070C, Phase 11 Emphasis) NIH contract. Further infrastructure support is enabled by the Case Western Reserve University Clinical Translational Research Collaborative (Davis, Pl 5UL1RR024989-05, CTSC), which provides additional expertise in drug development. While PSRS support explicitly does not overlap with these funding mechanisms, we are able to build upon the extensive local expertise in early phase clinical research in the design and conduct of Cancer Center studies eligible for PSRS. PSRS is limited to support of research nurses and data managers, and therefore leverages other institutional resources. A formalized process for award of PSRS funding begins with the submission of a 2 page letter of intent (LOI) and budget by principal investigators seeking PSRS for a particular study. This LOI undergoes structured evaluation by a Case CCC clinical research leadership committee with a determination of approval/disapproval. PSRS funds are disbursed based on protocol accrual, with per-patient reimbursement at rates determined at the time of approval of the application. Trials must be approved and prioritized by PRMC before any funds are distributed. To permit rapid real-time decision making, PSRS applications are accepted on a rolling basis. In the prior grant cycle, 431 patients were accrued to studies selected for PSRS.

Public Health Relevance

The Case Comprehensive Cancer Center is Northeast Ohio's only NCI designated comprehensive cancer center providing bench-to-bedside medical research involving partnerships between basic, clinical and population scientists to speed translation of laboratory discoveries into new prevention/intervention and cancer treatments.

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