Defense Health Agency Contracting Activity - DHACA

Description

The PCRP Clinical Consortium Award mechanism was previously offered in FY05, FY06, FY08, and FY13. Overall, 57 Clinical Consortium Award applications have been received, and 35 have been recommended for funding. This year the PCRP is offering the Clinical Consortium Research Site Award mechanism to support the inclusion of Clinical Research Sites to the existing Prostate Cancer Clinical Trials Consortium (PCCTC). The Clinical Consortium Research Site Award provides the support to develop and enhance collaborations and resources necessary for a network of organizations to rapidly execute Phase II or Phase II-linked Phase I (Phase I/II) prostate cancer clinical trials. These trials will include investigations of high-impact, novel therapeutic agents or approaches for the management or treatment of prostate cancer, especially as pertaining to the FY16 PCRP overarching challenges. In accordance with PCRP goals, the conduct of Phase I/II trials that incorporate investigations of biomarkers for risk assessment, early detection, prediction of aggressiveness, and/or progression of prostate cancer is particularly encouraged. The principal goal of the Clinical Consortium Research Site Award is to combine the efforts of leading investigators to bring to market high-impact, novel therapeutic interventions that will ultimately and significantly decrease the impact of prostate cancer. To facilitate global investigations, Principal Investigators (PIs) from both U.S. and international institutions are encouraged to apply. Investigators with access to patients in the Military Health System are also encouraged to apply. Submissions from institutions with enhanced access to patients from disproportionately affected populations are especially encouraged. The PCCTC currently consists of 11 Clinical Research Sites and one Coordinating Center. The Coordinating Center and Clinical Research Sites are jointly responsible for proposing, selecting, and conducting Phase II and Phase I/II clinical trials focused on prostate cancer therapeutic interventions. The structure of the Consortium is described in detail below. More information about the PCCTC can be found on its website (http://pcctc.org/). The Coordinating Center, in addition to functioning as a Clinical Research Site, serves as the Consortium information and planning nexus providing administrative, operational, and data management support services to participating Clinical Research Sites to implement Consortium clinical trials in a timely manner. Responsibilities of the Coordinating Center include the clinical trial selection process, protocol coordination, regulatory coordination, study management and monitoring, data collection, management and statistics, and intellectual/material property coordination. All Clinical Research Sites recommended for funding will be required to participate in at least one PCCTC clinical trial during the first year of the period of performance. Collectively, the Coordinating Center PI and Clinical Research Site PIs constitute the Clinical Consortium Committee (CCC), which collaboratively develops and maintains a procedure for the selection of clinical trials to be implemented within the Consortium. A representative from the PCRP must be invited to meetings of the CCC as well as any other formal meetings of the Consortium. All sites funded through this award mechanism will be responsible for working collaboratively within the PCCTC to identify new clinical trials for implementation. Any site may serve as an entry point for clinical trials that originate from outside the Consortium. The Coordinating Center is responsible for facilitating this entire process. The purpose of the PCRP Clinical Consortium Research Site Award is to provide the funding to establish the necessary collaborations and resources to rapidly execute clinical trials by the PCCTC, but will not fund research or the development of clinical protocols. As such, investigators are strongly encouraged to leverage DoD investments whenever possible by implementing DoD-funded trials.

Who can apply

• Unrestricted

Contact

CDMRP Help Desk <br/>301-682-5507
help@eBRAP.org