The DOD is offering the Amyotrophic Lateral Sclerosis Clinical Outcomes and Biomarkers Award to develop and validate clinical outcomes and biomarkers for ALS trials.

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.

Use of existing well-characterized and highly curated clinical resources is encouraged. Examples of patient-based ALS resources include ongoing or completed clinical trial datasets, biorepositories of clinical specimens, registries (e.g., Centers for Disease Control and Prevention National ALS Registry and/or Biorepository; https://www.cdc.gov/als/Default.html), large omics datasets, patient-report outcomes, digital biomarker datasets, and databases of clinical data and/or metadata. Active-duty military and/or Veteran patient populations or resources should be considered. A list of suitable resources can be found on the ALSRP web page (https://cdmrp.health.mil/alsrp/resources/ALSRPresources). Other resources may be used, provided they have an adequate description of repository parameters and mechanisms for broad access.

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.

Use of existing well-characterized and highly curated clinical resources is encouraged. Examples of patient-based ALS resources include ongoing or completed clinical trial datasets, biorepositories of clinical specimens, registries (e.g., Centers for Disease Control and Prevention National ALS Registry and/or Biorepository; https://www.cdc.gov/als/Default.html), large omics datasets, patient-report outcomes, digital biomarker datasets, and databases of clinical data and/or metadata. Active-duty military and/or Veteran patient populations or resources should be considered. A list of suitable resources can be found on the ALSRP web page (https://cdmrp.health.mil/alsrp/resources/ALSRPresources). Other resources may be used, provided they have an adequate description of repository parameters and mechanisms for broad access.

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.

Use of existing well-characterized and highly curated clinical resources is encouraged. Examples of patient-based ALS resources include ongoing or completed clinical trial datasets, biorepositories of clinical specimens, registries (e.g., Centers for Disease Control and Prevention National ALS Registry and/or Biorepository; https://www.cdc.gov/als/Default.html), large omics datasets, patient-report outcomes, digital biomarker datasets, and databases of clinical data and/or metadata. Active-duty military and/or Veteran patient populations or resources should be considered. A list of suitable resources can be found on the ALSRP web page (https://cdmrp.health.mil/alsrp/resources/ALSRPresources). Other resources may be used, provided they have an adequate description of repository parameters and mechanisms for broad access.