Description
The DoW Amyotrophic Lateral Sclerosis Research Program, Pilot Clinical Trial Award, 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). The program aims to improve outcomes and find cures for people with ALS. Applications must address one of two focus areas: Biomarker-Driven Interventions or Clinical Care. The award supports a clinical trial with a maximum period of performance of three years and a cost cap of $2.8M. Key elements of the application include a detailed Regulatory Strategy plan, a Transition Plan, and a community collaboration to optimize research impact.
• The clinical trial should begin no later than 12 months after the award date or 18 months for FDA-regulated studies.
• Projects proposing a therapeutic intervention must incorporate biomarkers specific to the intervention into the trial design.
• Applications must include a plan for project readiness, including availability of and access to clinical reagents and experimental therapeutics, and submission of an IND or IDE application to the FDA, if applicable.
• The application should describe how the outcomes of the study will be advanced to the next phase of development, beyond the scope of the funded work.