DoD Prostate Cancer, Clinical Consortium Award | W81XWH 21 PCRP CCA

Opportunity Information: Apply for W81XWH 21 PCRP CCA

The DoD Prostate Cancer Research Program (PCRP) Clinical Consortium Award (CCA) is designed to fund the infrastructure needed to run a coordinated network that can launch and execute phase 2 or phase 1/2 (phase 2-linked phase 1) prostate cancer clinical trials quickly. The emphasis is on testing high-impact, novel therapeutic agents or treatment approaches that align with the FY21 PCRP Overarching Challenges. A key point is that this mechanism is not meant to pay for the scientific research activities of the trials themselves as the primary purpose; instead, it supports the operational backbone that makes a high-throughput clinical trial enterprise possible, such as coordination, administration, data systems, regulatory support, and monitoring.

The program intends to stand up a formal consortium consisting of about 10 Clinical Research Sites plus one Coordinating Center, with a new FY21 requirement to also include at least two Affiliated Clinical Research Sites. These affiliated sites are expected to expand the consortiums reach by providing access to distinctive patient populations, especially individuals from high-risk, underserved, and/or military groups highlighted in the FY21 challenges. Both U.S. and international institutions are encouraged to apply, and applicants that can demonstrate stronger access to these priority populations are particularly sought. Applicants must explicitly choose whether they are applying to be the Coordinating Center (which also functions as a Clinical Research Site) or a Clinical Research Site only, and Coordinating Center applicants can still be considered as a site if they are not selected to lead the consortium.

Operationally, the Coordinating Center acts as the hub for planning, administration, and information flow across the network. Its responsibilities extend across the full trial enablement lifecycle: organizing the trial selection and prioritization process; coordinating protocol development; managing regulatory coordination across sites (including local IRB compliance and FDA-related requirements when investigational agents, devices, or procedures are involved); providing study management and monitoring; building and operating shared data collection, data management, and statistical support; and handling intellectual and material property coordination among participating institutions. The Coordinating Center must also establish communications systems and a quality assurance/quality control framework that can support real-time and remote monitoring, rapid adverse event reporting, timely medical review of participant data, interim outcome evaluation, and standardized handling and banking of specimens and imaging products generated through consortium studies.

A defining feature of this opportunity is that the consortium is expected to be trial-ready immediately. The Coordinating Center is required to bring forward two initial clinical trial protocols (with funding already secured) so the consortium can initiate them within the first three months of the performance period, and every participating site must join at least one of these initial trials. Beyond this startup requirement, the Coordinating Center must be able to coordinate and facilitate a high volume of activity, maintaining at least 12 clinical trials open at any given time after the first 12 months. In parallel, each Clinical Research Site is expected to be a full, active partner: helping introduce and select trials, accruing patients, submitting high-quality data on time, attending consortium meetings, following common operating procedures, and providing dedicated clinical research coordination staff to move protocols efficiently through regulatory steps and to support cross-site trial execution.

The governance model is centered on a Clinical Consortium Committee made up of the Coordinating Center PI and the site PIs. This committee jointly develops and maintains the procedures used to evaluate and choose trials for implementation, and it is expected to continually identify new phase 2 and phase 1/2 trials, including those originating outside the consortium (any site can serve as an entry point for an external proposal). A PCRP representative must be invited to committee meetings and other formal consortium meetings, reflecting the hands-on programmatic visibility typical of DoD research programs. The government may also require, at its discretion, a pre-award planning meeting to align consortium members on operations, reporting expectations, evaluation, and award negotiations.

The award includes explicit, quantified performance metrics that are tied to continued funding after the first 12 months, reinforcing that the consortium is expected to deliver measurable throughput and impact rather than simply establish partnerships. For the Coordinating Center, metrics include completing at least four trials in the first year, sustaining a portfolio of at least 12 open trials after year one, and advancing agents from at least 20 consortium trials to further testing (for example, to phase 3) with genuine potential to change clinical practice. The solicitation also makes clear that the consortium is not intended to run trials that are merely the next incremental iteration of an existing therapy. For Clinical Research Sites, required performance includes accruing at least 25 patients per year to consortium trials (with at least 20 of those patients going onto trials led by other consortium sites), participating in a minimum of eight trials initiated elsewhere in the consortium over four years, and proposing at least two trials per year (or eight over four years) for consortium consideration. Both the consortium overall and each site are expected to enroll patients from high-risk, underserved, and/or military populations, with a stated minimum of at least five such patients accrued (per site, and also reflected in overall consortium expectations).

Another major requirement, especially for Coordinating Center applicants, is planning for sustainability beyond the award period. Applications must include a financial sustainability plan that explains how the consortium will continue operating by leveraging partnerships, industry sponsorship, and/or additional funding sources after DoD support ends. Institutions that have held a prior PCRP Clinical Consortium Award must also address past performance against previous metrics and describe any disruptions (such as COVID-19 or major disasters) and how they will be mitigated to improve performance going forward.

From a funding and administrative standpoint, awards are issued as assistance agreements, meaning they can be structured either as a grant or a cooperative agreement depending on the anticipated level of DoD involvement during performance. If substantial agency involvement is expected (such as active collaboration, participation, or intervention), the award will be a cooperative agreement; if not, it will be a grant, with the final determination made during negotiations. Finally, the program stresses mission relevance: proposed work must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public, and collaborations between military or Veteran institutions and non-military institutions are strongly encouraged to combine expertise, infrastructure, and access to unique patient populations.

• The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Prostate Cancer, Clinical Consortium Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on Apr 08, 2021.
• Applicants must submit their applications by Sep 23, 2021. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 11 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

Apply for W81XWH 21 PCRP CCA

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: