Department of Defense (DOD) Fiscal Year 2005 (FY05) Prostate Cancer Clinical Consortium Award (CCA)

The summary for the Department of Defense (DOD) Fiscal Year 2005 (FY05) Prostate Cancer Clinical Consortium Award (CCA) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Dept of the Army USAMRAA, which is the U.S. government agency offering this grant.
Department of Defense (DOD) Fiscal Year 2005 (FY05) Prostate Cancer Clinical Consortium Award (CCA): 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: A minimum number of 35 patients accrued per year; however, the expectation will be that accrual rates of 50 or more patients per year will be achieved; The presentation of at least one clinical trial to the consortium per year; however, the expectation will be that two or more clinical trials per year will be proposed; Annual written progress report, semi-annual written briefings and presentations; and Timely submission of quality data as outlined by the Coordinating Center. To assess data collection and accuracy, at the discretion of the government, each participant site may be expected to participate in an on-site audit by the government or its designee.
Federal Grant Title: Department of Defense (DOD) Fiscal Year 2005 (FY05) Prostate Cancer Clinical Consortium Award (CCA)
Federal Agency Name: Dept of the Army USAMRAA
Grant Categories: Health
Type of Opportunity: Discretionary
Funding Opportunity Number: PC05-CCA
Type of Funding: Grant Cooperative Agreement
CFDA Numbers: 12.420
CFDA Descriptions: Military Medical Research and Development
Current Application Deadline: No deadline provided
Original Application Deadline: Jun 07, 2005
Posted Date: Feb 04, 2005
Creation Date: Feb 04, 2005
Archive Date: Aug 11, 2005
Total Program Funding: $15,000,000
Maximum Federal Grant Award: $1,000,000
Minimum Federal Grant Award:
Expected Number of Awards: 10
Cost Sharing or Matching: No
Applicants Eligible for this Grant
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
Link to Full Grant Announcement
Information not provided
Grant Announcement Contact
joseph little, 301-619-2546, [email protected] [email protected] joseph little
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