Department of Defense (DOD) Fiscal Year 2006 (FY06) Prostate Cancer Research Program (PCRP) Clinical Trial Award

The summary for the Department of Defense (DOD) Fiscal Year 2006 (FY06) Prostate Cancer Research Program (PCRP) Clinical Trial Award 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 2006 (FY06) Prostate Cancer Research Program (PCRP) Clinical Trial Award: The intent of the Clinical Trial Award is to provide for the rapid execution of novel patient-oriented research in a Phase I, Phase I/II, or Phase II clinical trial that has the potential to have a significant impact on prostate cancer. Proposals should focus on new interventions (e.g., drugs, biologics, and devices). It is expected that the clinical trial will be initiated within 6 months of the award date. This award is intended to support both new and established scientists across a broad spectrum of disciplines. The FY06 Clinical Trial Award is open to all eligible applicants with clinical trials relevant to prostate cancer treatment, diagnosis, detection, or prevention. Note that Investigational New Drug (IND) and Institutional Review Board (IRB) approvals should be in process or completed before submission of an application to this program. IND approval must be received before an award can be made. If IND approval is not received by April 30, 2007, the Government reserves the right to not fund the award. Funding from this award mechanism cannot be used for preclinical research studies; however, funds may be used for contract production of a drug or biological under Good Manufacturing Practices (GMP). Clinical Trial Awards will support Phase I, Phase I/II, and Phase II clinical trials (separate discussions are provided below for each type of clinical trial). Applicants must clearly specify in their proposals which type of clinical trial, Phase I, Phase I/II, or Phase II, is being proposed. Each proposal should contain only one clinical trial. Clinical trials must begin within 6 months of the award date. Local IRB approvals should be in process or completed before submission of the proposal to the Clinical Trial Award mechanism. 1. Phase I Clinical Trials: These trials should focus on determining the safety, toxicity, tolerability, and pharmacokinetics/pharmacodynamics of new interventions, devices, or treatment schedules in humans. It is expected that this award will allow the recipient the opportunity to obtain the data and experience necessary to conduct a Phase II clinical trial, if appropriate. Applicants for Phase I trials must include a clear scientific rationale for the trial as well as adequate preclinical supplemental data to support the feasibility of his or her hypotheses and approaches. Applicants must include a detailed plan for completing the Phase I trial during the performance period of the award and a clear experimental and appropriately powered statistical plan to perform the clinical trial. Phase I applicants are encouraged to pursue correlative studies. 2. Phase II Clinical Trials: These trials should focus on defining the efficacy of new interventions or devices. Applicants for Phase II clinical trials must include Phase I or pilot clinical trial data, adequate preclinical supplemental data to support the feasibility of their hypotheses and approaches, and a detailed plan for completion of the Phase II clinical trial during the award. Applicants must include a clear experimental and appropriately powered statistical plan to perform the Phase II clinical trial. Applicants are encouraged to pursue correlative studies. 3. Phase I/II Clinical Trials: These are Phase II-linked Phase I (Phase I/II) clinical trials, which must address all applicable requirements detailed above under Phase I and Phase II. If the trial is multi-institutional, applicants should include plans for communication and real-time data transfer between the collaborating institutions as well as how specimens and/or imaging products obtained during the study will be handled in the appropriate sections of the Clinical Protocol (see Subsection V.K). An intellectual and material property plan agreed upon by all participating institutions is also required for multi-institutional clinical trials as part of the Supporting Documentation (see Subsection V.L). Please note that all DOD-funded research involving human subjects, human anatomical substances, and/or cadavers must be reviewed and approved by the USAMRMC Human Subjects Research Review Board (HSRRB) in addition to local IRBs. The HSRRB has different requirements than local IRBs. The average time to obtain HSRRB approval is approximately 6 months. Therefore, it is strongly suggested that the applicant plan the budget and timeline accordingly. Important aspects of the Clinical Trial Award are: The proposal must include a named study coordinator who will guide the clinical protocol through IRB, HSRRB, and other regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual. IRB approvals should be in process or completed before submission of the proposal to the Clinical Trial Award mechanism. IND or Investigational Device Exemption (IDE) approvals should be in process or completed before submission of the proposal to the Clinical Trial Award mechanism. IND approval must be received before an award can be made. The clinical trial should have a potentially high impact. The clinical trial must have clearly defined and appropriate endpoints. The proposal must include a well-written clinical protocol.
Federal Grant Title: Department of Defense (DOD) Fiscal Year 2006 (FY06) Prostate Cancer Research Program (PCRP) Clinical Trial Award
Federal Agency Name: Dept of the Army USAMRAA
Grant Categories: Science and Technology
Type of Opportunity: Mandatory
Funding Opportunity Number: W81XWH-06-PCRP-CTA
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 20, 2006 Deadline for submittals is 5:00PM Ea
Posted Date: Feb 16, 2006
Creation Date: Feb 16, 2006
Archive Date: Jul 20, 2006
Total Program Funding: $3,000,000
Maximum Federal Grant Award: $750,000
Minimum Federal Grant Award:
Expected Number of Awards: 3
Cost Sharing or Matching: Yes
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
Contract Specialist
Phone 301-619-2546 [email protected] Email for POC is
Similar Government Grants
DoD Peer Reviewed Medical, Impact Award
DoD Peer Reviewed Medical, Lifestyle and Behavioral Health Interventions Research Award
DoD Peer Reviewed Medical, Discovery Award
DoD Peer Reviewed Medical, Technology/Therapeutic Development Award
DoD Peer Reviewed Medical, Clinical Trial Award
FY2006 Deployed War Fighter Protection Research Program
Department of Defense (DOD) Fiscal Year 2003 (FY03) Breast Cancer Research Program (BCRP)C...
Department of Defense (DOD) Fiscal Year 2004 (FY04) Breast Cancer Research Program (BCRP) ...
More Grants from the Dept of the Army USAMRAA
Spinal Cord Injury Research Program Clinical Translation Research Award
Spinal Cord Injury Research Program Clinical Trial Award
DoD Hearing Restoration Focused Research Award
DOD Spinal Cord Injury Research Program Translational Research Award
DoD Autism, Clinical Trial Award

FederalGrants.com is not endorsed by, or affiliated with, any government agency. Copyright ©2007-2024 FederalGrants.com