DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award
Defense Health Agency Contracting Activity - DHACA · Opportunity HT942526ALSRPPCTA
≈ 2 awards expected
Who can apply
- Unrestricted
About this opportunity
Summary: The fiscal year 2026 (FY26) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award (PCTA) supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of amyotrophic lateral sclerosis (ALS). Projects may range from phase 1 to small-scale phase 2 trials.Applications must address one of the following focus areas:· Biomarker-Driven Interventions: Disease-modifying interventions, with mechanism-specific biomarkers to predict which clinical trial participants are likely to respond, demonstrate target engagement, and effects on the intended biological pathway.· Clinical Care: Improving aspects of clinical care and symptom management for ALS.Distinctive Features: Funding from this award mechanism must support a clinical trial. The clinical trial should begin no later than 12 months after the award date or 18 months for U.S. Food and Drug Administration (FDA)-regulated studies.Projects proposing a therapeutic intervention (drug, biologic, and/or device) must incorporate biomarkers specific to the intervention into the trial design.All pre-applications and applications are required to incorporate community collaboration, as described in Section 3.2.2, to optimize research impact.Applications must include a detailed Regulatory Strategy plan that outlines the approach for obtaining regulatory approvals, if required, specifically for the funded portion of the study. In addition, applications must provide a separate Transition Plan that describes how the outcomes of the study will be advanced to the next phase of development, beyond the scope of the funded work.
Portfolio context — this listing covers more than this opportunity
This opportunity is funded under Assistance Listing 12.420 (“Military Medical Research and Development”), a broad federal program that made about 1078 new awards per year over the last five fiscal years (median award $846k). Those figures describe that whole portfolio — not this specific solicitation, so we don't show them as if they were this opportunity's track record.
Applicant counts per solicitation are not published by any federal agency — no one can honestly sell you that number. CDMRP publishes cumulative applications received and funded per program — source.
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