DOD Amyotrophic Lateral Sclerosis, Clinical Biomarker Development Award

The intent of the FY23 ALSRP Clinical Biomarker Development Award is to support the development of biomarkers to enrich clinical trials in Amyotrophic Lateral Sclerosis (ALS). Biomarker development projects can be relevant to a specific therapy, a class of therapeutics, or to a specific ALS subtype (such as a particular genetic mutation) and do not have to broadly apply to all patients. A description of the biomarker category and intended context of use (COU) in ALS therapeutic development, including regulatory considerations for use in ALS clinical trials or clinical practice, is an important component.Examples of studies appropriate for submission to the FY23 ALSRP Clinical Biomarker Development Award include, but are not limited to:Using patient-based resources to link biosamples to rigorous molecular data.Collecting and analyzing biospecimens as a companion to an anticipated/ongoing clinical trial.Correlation of clinical trial-related data (e.g., biosample analysis, imaging, or epidemiological data) with clinical outcomes or responses to therapies.Strategies to better measure disease progression, including the development or use of digital biomarkers.
Categories: Science and Technology and other Research and Development.