The purpose of Protocol Specific Research Support (PSRS) is to help VICC continue its commitment to high quality, scientifically meritorious translational research intended to lead to further trials and/or to lead to peer-reviewed support. The Resource Allocation Committee (RAC) distributes these important funds to deserving clinical trials. James Whitlock, M.D., a pediatric oncologist, chairs the RAC, which includes the VICC Director and Deputy Director along with representatives from Medical Oncology, Surgical Oncology, and Radiation Oncology. Investigator-initiated feasibility/Phase I or pilot trials are judged for scientific merit based on an independent internal or external scientific review. The criteria include whether the trial originates from preclinical work performed within the VICC, the potential to lead to external peer-reviewed funding, the potential to lead to a larger multi-institutional pivotal Phase 11 or Phase 111 trial, or whether the trial has unique laboratory correlates integrated into its primary or secondary aims/objectives. Career development goals (preferential consideration for junior faculty) are also considered. During the last grant cycle, the VICC committed philanthropy funds to supplement the PSRS funds broadening RAC's ability to support trials that have limited grant support and to fund some correlative studies for exploratory analysis. Full review for both types of funds are carried out in at least quarterly meetings, with ad hoc meetings held based on need. Preparation of an information packet including the protocol, its relevance, budget shortfall and rationale, and future directions can be performed from the web-based tool for RAC submission and funds are available to all VICC investigators. In the last grant cycle, 13 trials qualified for PSRS funds, four of which are still open, one closed early, three were not recommended for further development, one led to a phase 11 trial that received pilot funding (also from RAC), one has a further LOI, one is now part of an ECOG trial and two are awaiting final data analysis. There are currently eight trials studying five disease sites under consideration for PSRS funding, including two trials developed by trainees. Thus, PSRS funding is crucial to the translational research work done at Vanderbilt. We have been successful at funding pilot studies and in the next grant cycle anticipate continuing to fund high-impact investigator initiated trials.
The translation of laboratory observations into clinical trials and development of new ideas often result in early concepts that are underfunded. The support provided from PSRS allows the continued development of novel trials that may lead to further later phase trials and/or peer-reviewed support.
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