DoD Prostate Cancer Clinical Consortium Award

Description

The PCRP Clinical Consortium Award mechanism was first offered in FY05, and again in FY06, FY08, and FY13. In FY16, the Clinical Consortium Research Site Award was offered. A total of 75 Clinical Consortium Award applications have been received, and 42 have been recommended for funding.The anticipated direct costs budgeted for the entire period of performance for an FY17 PCRP Clinical Consortium Award will not exceed $3,600,000 for the Coordinating Center and will not exceed $600,000 for each Clinical Research Site. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.The Clinical Consortium Award mechanism 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 FY17 PCRP Overarching Challenges. Support from this award is directed toward consortium infrastructure needs rather than direct support of the research itself. 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 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 the disease. To facilitate global investigations, Principal Investigators (PIs) from both U.S. and international institutions are encouraged to apply. Submissions from institutions with enhanced access to patients in the Military Health System and/or from disproportionately affected populations (including, but not limited to, socioeconomic status, access to health care, age, geography, race, and ethnicity) are especially encouraged.The FY17 PCRP Clinical Consortium Award mechanism will be used to select and fund a single Coordinating Center and two Clinical Research Sites. PIs will be required to indicate whether the institution is applying as either the Coordinating Center with a Clinical Research Site or as a Clinical Research Site only. PIs applying as the Coordinating Center, if not selected for funding, have the option to still be considered as a Clinical Research Site only. The Coordinating Center and Clinical Research Sites will be jointly responsible for proposing, selecting, and conducting Phase II and Phase I/II clinical trials focused on prostate cancer therapeutic interventions. The PCRP Clinical Consortium is expected to consist of one Coordinating Center and approximately 8 to 12 Clinical Research Sites. The Coordinating Center and Clinical Research Sites funded by the FY17 PCRP Clinical Consortium Award will work with other currently funded FY16 PCRP Clinical Research Sites. Additional details regarding the structure of the consortium are described in detail below.The Coordinating Center, in addition to functioning as a Clinical Research Site, will serve 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 will include 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 will also be responsible for preparing two clinical trials, with funding already secured, to be initiated by the consortium within the first 3 months of the performance period. All sites (Clinical Research Sites and the Coordinating Center) will be required to participate in at least one of these two initial clinical trials.Collectively, the Coordinating Center PI and Clinical Research Site PIs will constitute the Clinical Consortium Committee, which will collaboratively develop and maintain 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 Clinical Consortium Committee as well as any other formal meetings of the consortium. All sites will be responsible for working collaboratively 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 will be responsible for facilitating this entire process. The consortium is strongly encouraged to leverage the Department of Defense (DoD) investment whenever possible by implementing DoD-funded trials.Key requirements of the Clinical Consortium Award include: 1. Responsibilities of the Consortium Participants: Procedures for the consortium, while proposed by the Coordinating Center, will be fully developed and agreed upon by all participants working collaboratively. At the discretion and expense of the Government, a pre-award planning meeting may be required.a. Coordinating Center: Responsibilities specific to the Coordinating Center include:• Adherence to the responsibilities delineated below for a Clinical Research Site.• Coordination and facilitation of at least 12 clinical trials at any given time after the first 12 months of the performance period. Development and maintenance of the consortium organizational structure.• Provision of at least two initial Phase II or Phase I/II clinical trial protocols for implementation by the consortium within the first 3 months of the performance period.• 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 U.S. Food and Drug Administration (FDA) requirements for investigational agents, devices, and procedures.• Establishment and management of a communications plan and an ongoing communications system between the Coordinating Center and Clinical Research Sites.• Management of consortium-developed quality assurance and quality control mechanisms for study monitoring, including:○ Real-time and remote monitoring program.○ 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.○ Registration, tracking, and reporting of participant accrual.○ Timely medical review and assessment of participant data.○ Rapid reporting and communication of adverse events.○ 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 and execution of a plan to establish financial independence from DoD funding by the end of the award period of performance.• Development and execution of plans for ongoing review by the consortium’s External Advisory Board (EAB), to include participation by Government representatives. EAB reviews should be conducted no less than twice yearly.b. Clinical Research Sites: The responsibilities of each site include:• If required by the Government, participation in a pre-award planning meeting with all consortium members to discuss operational features of the consortium, the requirements for progress and evaluation, and the award negotiations process.• Full participation in the consortium, including but not limited to, clinical trial introduction and selection, patient accrual for consortium studies (to include accrual from disproportionately affected populations), data collection and timely submissions, meeting attendance, and adherence to the consortium’s operating procedures.• Presentation of at least two clinical trials for the consortium’s consideration per year. For the Coordinating Center, this requirement is in addition to the initial two clinical trials required at the beginning of the award.• Meeting minimum accrual requirements of 25 patients per year, either independently or in partnership with other non-consortium institutions. At least 20% of these patients must be contributions to trials from other consortium sites, and at least 5% of all accrued patients at each site must be from disproportionately affected populations.• 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 consortium’s core data collection methodology and strategies.• Compliance with consortium-developed quality assurance and quality

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