The PCRP Clinical Consortium Award will provide support to develop a consortium whose function will be to facilitate the rapid execution of collaborative Phase II or Phase II-linked Phase I (Phase I/II) clinical trials testing therapeutic agents or approaches for the management or treatment of prostate cancer. The overarching goal of the Clinical Consortium Award is to combine the efforts of the nations leading investigators to bring to market novel therapeutic interventions that will ultimately decrease the overall impact of the disease.
The consortium will consist of 8-10 Clinical Research Sites and one Coordinating Center. These participants will be responsible jointly for proposing, selecting, and conducting Phase II and Phase I/II clinical trials focused on prostate cancer therapeutic interventions. In addition to functioning as a Clinical Research Site, the Coordinating Center will serve as the consortium information and planning nexus. Eligible applicants are defined as a single for-profit, nonprofit, public, or private institution or organization.
The Coordinating Center will have multidisciplinary expertise and extensive experience in developing and conducting multi-institutional clinical trials of innovative treatment approaches in support of prostate cancer research. In addition to functioning as a Clinical Research Site, the Coordinating Center will be responsible for providing administrative, operational, and data management support services to participant Clinical Research Sites to implement consortium clinical trials in a timely manner. The Coordinating Center also will be responsible for preparing two initial clinical trials for immediate implementation by the consortium at the start of the award. All sites (Clinical Research Sites and the Coordinating Center) will be required to participate in at least one of these two initial clinical trials. A procedure will be established for the selection of clinical trials to be implemented thereafter within the consortium.
After implementation of the initial clinical trials prepared by the Coordinating Center, all sites will be responsible for working collaboratively to identify new clinical trials for implementation by the consortium. Collectively, the consortium Principal Investigators (PIs) will constitute the Clinical Consortium Committee which will be responsible for selecting the clinical trials to be implemented by the consortium and for determining which consortium institutions will participate in each trial. A representative from USAMRMC must be invited to these sessions as well as any other formal meetings of the consortium. Selected clinical trials will be maintained in a queue and prepared for implementation as resources become available. All sites may serve as entry points for clinical trials that originate from outside the consortium. The Coordinating Center will be responsible for facilitating this entire process. The consortium is strongly encouraged to leverage the DOD investment whenever possible by implementing DOD-funded trials. After the initial 6 months of the performance period of the award, the consortium is expected to have 10 or more clinical trials open at any given time. In addition, each participant site is expected to present two or more clinical trials each year for the consortiums consideration and maintain accrual of 50 or more patients per year.
The PCRP Integration Panel (IP) and Program Manager will assume the role of an external advisory board (EAB) to the consortium. The role of the EAB will be to provide scientific review, consortium oversight, and data and progress review. PIs must present written and oral semi-annual briefings to the EAB and USAMRMC staff at 1-day meetings typically held in the Baltimore-Washington, DC area. Based on these reports and presentations, the EAB and USAMRMC staff will evaluate progress, provide feedback, and invoke modifications and terminations as needed to facilitate the success of the consortium. PIs also will be required to submit annual written progress reports and a final written comprehensive report.
Funding for each participant site in years 2 and 3 will be contingent upon meeting the following consortium requirements:
Who can apply:
Eligible functional categories:
Military Medical Research and Development
Department of Defense (DOD) Fiscal Year 2005 (FY05) Prostate Cancer Clinical Consortium Award (CCA)
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US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014