DoD Prostate Cancer, Clinical Consortium Award

Description

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 2 or phase 2-linked phase 1 (phase 1/2) 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 as pertaining to the FY21 PCRP Overarching Challenges. Support from this award is directed toward consortium infrastructure needs rather than direct support of the research itself.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 from high-risk, underserved, and/or military populations (as described in the FY21 PCRP Overarching Challenges) are especially encouraged.The FY21 PCRP Clinical Consortium Award mechanism will be used to select and fund approximately 10 Clinical Research Sites and one Coordinating Center. NEW FOR FY21: In addition, the consortium will include two or more identified Affiliated Clinical Research Sites to be supported and managed by the Coordinating Center. Affiliated Clinical Research Sites should have enhanced access to patients from high-risk, underserved, and/or military populations.PIs will be required to indicate whether the institution is applying as either the Coordinating Center with a Clinical Research Site or a Clinical Research Site only. Institutions 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 2 and phase 1/2 clinical trials focused on prostate cancer therapeutic interventions. 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 theClinical Consortium Committee, which will collaboratively develop and maintain a procedure for theselection of clinical trials to be implemented within the consortium. A representative from thePCRP must be invited to meetings of the Clinical Consortium Committee, as well as any other formalmeetings of the consortium. All sites will be responsible for working collaboratively to identifynew clinical trials for implementation. Any site may serve as an entry point for clinical trialsthat originate from outside the consortium. The Coordinating Center will be responsible forfacilitating this entire process.Key requirements of the Clinical Consortium Award include:• Responsibilities of the Consortium Participants: Procedures for the consortium, whileproposed by the Coordinating Center, will be fully developed and agreed upon by all participantsworking collaboratively. All references to clinical trials in the outlined responsibilities arespecific to phase 2 or phase 1/2 trials; phase 3 or higher clinical trials are not included. Atthe discretion and expense of the government, a pre-award planning meeting may be required.○ 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 thefirst 12 months of the performance period.– Development and execution of plans for the incorporation, support, and involvement of nofewer than two Affiliate Clinical Research Sites (of U.S. or international origin) intended toenhance the impact of the consortium by contributing unique patient populations to consortiumtrials, including those from high-risk, underserved, and/or military populations (as described inthe FY21 PCRP Overarching Challenges). The Coordinating Center will establish performance metricsfor Affiliate Clinical Research Sites, which should emphasize higher accrual rates for the uniquepatient population(s) the site has enhanced access. The government reserves the right to requestthe identification of alternative Affiliate Clinical Research Sites prior to award if thoseidentified in the application do not demonstrate sufficient access to identified patientpopulations.– Development and maintenance of the consortium organizational structure.– Provision of at least two initial clinical trial protocols for implementation by theconsortium within the first 3 months of the performance period.– Management of consortium-developed procedures for review, selection, and implementation ofclinical trials proposed by or through consortium members.– Establishment and management of procedures to ensure compliance with the local InstitutionalReview Boards (IRBs) of all sites for the conduct of clinical trials and the protection of humansubjects.– Establishment and management of procedures for ensuring compliance with 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 for financial sustainability leveraging collaborations, industry sponsors, and/or other funding opportunities to allow consortium activities to continue beyond the award period of performance.– Presentation of written and/or oral briefings to the PCRP Programmatic Panel and U.S. Army Medical Research and Development Command (USAMRDC) staff at 1-day meetings typically held in the Baltimore-Washington, DC area.○ 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 high-risk, underserved, and/or military 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 high-risk, underserved, and/or military 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-de

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