DoD Grant: ALS Clinical Biomarker Development Award

The intent of the FY22 ALSRP Clinical Biomarker Development Award (CBDA) is to maximize clinical ALS resources and biorepositories to better define subtypes, assess prognosis, or predict therapeutic response and to improve value of clinical trials. Applications should focus on the development and improvement of clinical biomarkers to enrich clinical trials in ALS. Biomarkers may be predictive/cohort-selective, prognostic, and/or pharmacodynamic. Biomarker development or data analysis can be relevant to a specific therapeutic or class of therapeutics, or to a specific type of ALS (such as a particular genetic mutation) and does not have to broadly apply to all patients. Analysis of results and/or biosamples collected under these projects should be made broadly available through deposition in existing publicly available curated repositories and data platforms when possible.

Clinical trials are not allowed for this award mechanism. A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Investigators interested in intervention clinical trials should consider applying under the FY22 ALSRP Pilot Clinical Trial Award (Funding Opportunity Number: W81XWH-22-ALSRP-PCTA). For information about other FY22 ALSRP award mechanisms, see https://cdmrp.army.mil/funding/alsrp.

Use of existing well-characterized and highly curated clinical resources is encouraged. Examples of human-based ALS resources include ongoing or completed clinical trial datasets, biorepositories of clinical specimens, large transcriptome/proteome/metabolomic datasets, and databases of clinical data and/or metadata. The applicant must demonstrate availability of, and accessibility to, the necessary resources to accomplish the proposed aims. Resources should be available at the time of application submission, however, collection of new specimens and/or data from participants in an existing cohort is allowed. Applications are encouraged to include diversity in their sample populations.

A list of suitable resources can be found on the ALSRP web page (https://cdmrp.army.mil/ alsrp/resources/ALSRPresources). Other resources may be used, provided they have an adequate description of repository parameters and mechanisms for broad access.

Examples of studies appropriate for submission to the FY22 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.

• Correlating clinical trial-related data (e.g., biosample analysis, imaging, or epidemiological data) with clinical outcomes or responses to therapies.

Early-career investigators and/or early-career physician scientists are encouraged to apply for the FY22 ALSRP Clinical Biomarker Development Award.