Congressionally Directed Medical Research Programs -- Amyotrophic Lateral Sclerosis Research Program -- Clinical Outcomes and Biomarkers Award

Funding Agency:
Department of Defense

The FY24 ALSRP Clinical Outcomes and Biomarkers Award (COBA) supports the development and/or validation of clinical outcomes and biomarkers to enrich clinical trials in Amyotrophic Lateral Sclerosis (ALS). 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.

Research may include, but is not limited to:
• Target engagement biomarkers.
• Objective pharmacodynamic biomarkers to measure the biological effect of an investigational therapeutic.

• Predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual patient or patient subgroup.
• Diagnostic, prognostic, or disease progression
• Validate clinician-, observer-, patient-reported and/or performance outcomes to better support clinical trial success metrics.
• Define ALS subtypes using patient-based resources to link biosamples and/or digital data elements to rigorous molecular and clinical data.
• Realize improved strategies that better measure disease progression for people living with ALS.
• Augment biospecimens, outcome, or digital health data to an on-going clinical trial.
• Correlate clinical-trial related data (e.g., biosample, imaging, digital health data) with clinical outcomes or responses to therapies.

Deadlines:
• Required Pre-Application Deadline: May 24, 2024
• Application Submission Deadline: July 10, 2024

Agency Website

Areas of Interest

To meet the intent of the funding opportunity, applications must address ONE or BOTH of the following focus areas:

Clinical Biomarkers: Identification, development, and/or validation of promising biomarkers for ALS. Biomarkers may include, but are not limited to, target engagement objective pharmacodynamic biomarkers to measure the biological effect of an investigational therapeutic, predictive/cohort-selective biomarkers, or digital health measures, including wearable devices, smart-phone sensors, video or voice recordings, imaging studies, or other devices which record disease-relevant physiological data.

Clinical Outcomes: Identification, development, and/or validation of clinician-, observer-, or patient-reported, and/or performance outcome measures for ALS. Projects may include optimization of current outcome measures already in use.

Eligibility Requirements

Independent investigators at all career levels may be named by the organization as the Principal Investigator (PI) on the application.
An eligible PI, regardless of ethnicity, nationality, or citizenship status, must be employed by or affiliated with an eligible organization.

Amount

$750,000

Amount Description

The anticipated direct costs budgeted for the entire period of performance for an FY24 ALSRP COBA Award should not exceed $750,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Funding Type

Award
Grant

Eligibility

Faculty
Junior Faculty
Post Doctoral Fellows

Category

Environmental & Life Sciences
Medical
Medical - Clinical Science

External Deadline

May 24, 2024