DoW Peer Reviewed Medical, Clinical Trial Award

Summary: The fiscal year 2026 (FY26) Peer Reviewed Medical Research Program (PRMRP) Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have significant impact on the treatment and management of a disease or condition addressed in one of the congressionally directed FY26 PRMRP topic areas and FY26 PRMRP strategic goals.Distinctive Features: Must support a clinical trial. Supports two different application categories, based on the phase of planning for the clinical trial: Clinical Trial Only or Clinical Trial with Planning Phase. The Clinical Trial with Planning Phase option is intended to support the final phase of regulatory activities and planning activities that are necessary to be completed prior to initiation of the clinical trial. The planning phase cannot be used to finalize the intervention or support animal studies. Applications that already have regulatory approvals in place and are submitting to the Clinical Trial Only option may be prioritized over those requesting the Planning Phase option. Animal studies are not supported. Studies must complete all preclinical empirical laboratory work prior to the award start date.Supports three funding levels, each offered with and without a Planning Phase:Funding Level 1: Supports phase 0 or phase 1 clinical trials or non-phased trials with fewer than 100 participants.Funding Level 2: Supports phase 2 clinical trials or non-phased trials with fewer than 300 participants.Funding Level 3: Supports phase 3 clinical trials or non-phased trials with more than 300 participants.Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $94.5M to fund approximately 9 Clinical Trial Award applications with total cost caps of $800,000 for the planning phase of a Clinical Trial with Planning Phase, $6M for Funding Level 1, $10M for Funding Level 2, and $20M for Funding Level 3 per award. The maximum period of performance is 4 years for the clinical trial, and 12 months for the planning phase. It is anticipated that awards made from this FY26 funding opportunity will be funded with FY26 funds, which will expire for use on September 30, 2032. Awards supported with FY26 funds will be made no later than September 30, 2027.