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

The summary for the Department of Defense (DOD) Fiscal Year 2006 (FY06) Prostate Cancer Research Program (PCRP) Clinical Consortium 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 Consortium Award: 1. General Information: The intent of the FY06 PCRP Clinical Consortium Award is to recruit additional sites into the existing PCRP Clinical Consortium, which facilitates 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 PCRP in establishing the Clinical Consortium 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 PCRP Clinical Consortium currently comprises seven Clinical Research Sites and one Coordinating Center, which jointly are responsible jointly for proposing, selecting, and conducting Phase II and Phase I/II clinical trials focused on prostate cancer therapeutic interventions. The Coordinating Center, which functions as a Clinical Research Site, also serves as the consortium information and planning nexus providing administrative, operational, and data management support services to participant Clinical Research Sites to implement consortium clinical trials in a timely manner. The Clinical Consortium organizational structure includes the following key features (see Figure 1 below): Coordinating Center: The Coordinating Center is required for the administration and day-to-day management of consortium operations, development of the clinical trial selection process, protocol coordination, regulatory coordination, study management and monitoring, data collection, management and statistics, and intellectual/material property coordination. The Coordinating Center also functions as a Clinical Research Site, Clinical Research Sites: Clinical Research Sites conceive, develop, and conduct clinical trials in prostate cancer and serve as entry points for clinical trials from outside the consortium, Clinical Consortium Committee: This central committee is composed of the Principal Investigators from the Coordinating Center and Clinical Research Sites, for the clinical trial selection process, and for the continual development and operation of the consortium. A representative from the USAMRMC is to be invited to all formal meetings for the Clinical Consortium Committee, and External Advisory Board (EAB): The EAB, which includes members of the PCRP Integration Panel, the PCRP Program Manager and the CDMRP Grants Manager for the Clinical Consortium, provides scientific review, oversight, data monitoring, and evaluation. All Consortium sites, including the Coordinating Center, are responsible for working collaboratively on the Clinical Consortium Committee to identify new clinical trials for implementation by the Consortium. Consortium members periodically propose new clinical trials to the Consortium, vote to decide which clinical trials will be implemented, and determine which Consortium institutions will participate. A representative from the USAMRMC must be invited to these sessions and any other formal meetings of the Consortium. Selected clinical trials are 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 is responsible for facilitating this entire process. The Consortium is strongly encouraged to leverage the DOD investment whenever possible by including DOD-funded trials that meet the entry criteria established by the Clinical Consortium Committee. The PCRP Integration Panel, the PCRP Program Manager, and the CDMRP Grants Manager for the Clinical Consortium function as an external advisory board to the Consortium by providing scientific review, consortium oversight, and data and progress review. Based on these reports and presentations, the EAB and USAMRMC staff will evaluate the progress, provide feedback, and invoke modifications and terminations as needed to facilitate the success of the consortium. An important aspect of the Clinical Consortium Award is that funding for each participant site after the first year is contingent upon meeting the following consortium requirements: A minimum number of 35 patients accrued per year; however, the expectation is 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 is that two or more clinical trials will be proposed; Submission of an 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, each participant site may be expected to participate in an on-site audit at the discretion of the Government by the Government or its designee. Failure to achieve the minimum requirements outlined above may result in termination of individual award(s). The Clinical Consortium Award does not provide funding for research but rather provides the support to develop the collaborations and resources necessary for the consortium to rapidly execute Phase II and Phase I/II clinical trials. 2. Responsibilities of Consortium Participants a. Responsibilities of the Clinical Research Sites: These include: Full participation in the Consortium, including, but not limited to, clinical trial introduction and selection, patient accrual for consortium studies, data collection and timely submissions, meeting attendance, and adherence to the consortiums operating procedures; Participation in clinical trials selected by the Consortium; Provision for a Clinical Research Coordinator who will interact with the Clinical Research Coordinators of other Clinical Research Sites and the Supervising Clinical Research Coordinator of the Coordinating Center to expedite and guide clinical protocols through the regulatory approval processes and to coordinate patient accrual and study activities across sites; Implementation of the consortiums standardized procedures and participation in consortium functions; Meeting minimum accrual requirements of 35 patients per year; however, the expectation is that enrollment of 50 patients or more per year will be achieved annually; Implementation of the Consortiums core data collection methodology and strategies; Compliance with Consortium-developed quality assurance and quality control procedures, as appropriate, including: o Participation in an on-site monitoring program to be managed by the Coordinating Center, o Implementation of the Consortium-developed management plan for acquisition and aggregation of protocol-specified tumor specimens, biological fluids, and relevant clinical data to the appropriate laboratories for testing or storage necessary for the conduct and analyses of clinical trials during the performance period of the award, o Submission of appropriate data and materials to allow for verification and review of protocol-related procedures, for example, pathology, imaging techniques, surgical methods, and therapeutic use; Implementation of procedures established by the Coordinating Center for ensuring compliance with US Food and Drug Administration (FDA) requirements for investigational agents, as appropriate; Preparation and presentation of written and oral semi-annual briefings to the Integration Panel EAB and USAMRMC staff at 1-day meetings typically held in the Baltimore-Washington, DC area; and Additional responsibilities based on recommendations and guidance from the Consortium Integration Panel EAB and USAMRMC staff. b. Responsibilities of the Coordinating Center: These include: Adherence to the responsibilities delineated above for a Clinical Research Site; Ensuring that at least 5 clinical trials are open at any given time, with the expectation that at least 10 clinical trials will be open at any given time; Development and maintenance of the consortium organizational structure; Management of consortium-developed procedures for review, selection, and implementation of clinical trials proposed by or through consortium members; Establishment and management of procedures to ensure compliance with the local Institutional Review Boards (IRBs) of all sites for the conduct of clinical trials and the protection of human subjects; Establishment and management of procedures for ensuring compliance with FDA requirements for investigational agents, devices, and procedures; Establishment and management of a communications plan and a real-time communications system between the Coordinating Center and Clinical Research Sites; Management of Consortium-developed quality assurance and quality control mechanisms for study monitoring, including: o On-site monitoring program, o Management plan for the handling, distribution, analysis, and banking of specimens and/or imaging products generated from Consortium studies necessary for the conduct and analyses of clinical trials during the performance period of the award; o Registration, tracking, and reporting of participant accrual, o Timely medical review and assessment of participant data, o Rapid reporting and communication of adverse events, and o Interim evaluation and consideration of measures of outcome; Management of Consortium-developed comprehensive data collection and data management systems that addresses the needs of all sites in terms of access to data, data security, and data integrity measures; Development of statistical plans for all Consortium clinical trials; Management of Consortium-developed intellectual and material property issues among institutions participating in the Consortium; Management of Consortium-developed procedures for the timely publication of major findings and other public dissemination of data; Development, organization, and submission of the written and oral semi-annual briefings to the EAB and USAMRMC staff at 1-day meetings typically held in the Baltimore-Washington, DC area; and Development, organization, and submission of the annual written progress reports and a final written comprehensive report to the USAMRMC (see Subsection VII.E.1).
Federal Grant Title: Department of Defense (DOD) Fiscal Year 2006 (FY06) Prostate Cancer Research Program (PCRP) Clinical Consortium Award
Federal Agency Name: Dept of the Army USAMRAA
Grant Categories: Science and Technology
Type of Opportunity: Mandatory
Funding Opportunity Number: W81XWH-06-PCRP-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 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: $1,800,000
Maximum Federal Grant Award: $600,000
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
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