The Department of Defense is offering the Amyotrophic Lateral Sclerosis Clinical Development Award to support correlative studies leveraging human-based ALS resources.

The intent of the FY21 ALSRP Clinical Development Award is to support correlative studies leveraging human-based ALS resources to enrich clinical trials or to optimize components of current ALS clinical care. Leveraging can refer to the use of existing well-characterized and highly curated resources or collaboration with ongoing clinical research to amplify potential gains in knowledge. 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.

Clinical intervention studies do not meet the intent of this funding opportunity. Investigators interested in intervention clinical trials should consider applying under the FY21 ALSRP Therapeutic/Biomarker Trial Pilot Award (Funding Opportunity Number: W81XWH-21- ALSRP-TBPTA). For information about these 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 Clinical Development Award include, but are not limited to:

•         Using human subject-based resources to better define subtypes, predict therapeutic response, or assess prognosis. Biomarker development or data analysis may 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.

·         Correlating clinical trial-related biosamples, imaging, or epidemiological data with clinical outcomes.

·         Adding a biomarker companion or observational aim to an anticipated/ongoing clinical trial (standalone intervention clinical trials will not be supported).

·         Observational studies to optimize components of current established ALS multidisciplinary clinical care, such as respiratory care strategies, use of approved devices, or specific symptom management strategies and assistive technologies.

Early-career investigators and/or early-career physician scientists are encouraged to apply for the FY21 ALSRP Clinical Development Award.

The intent of the FY21 ALSRP Clinical Development Award is to support correlative studies leveraging human-based ALS resources to enrich clinical trials or to optimize components of current ALS clinical care. Leveraging can refer to the use of existing well-characterized and highly curated resources or collaboration with ongoing clinical research to amplify potential gains in knowledge. 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.

Clinical intervention studies do not meet the intent of this funding opportunity. Investigators interested in intervention clinical trials should consider applying under the FY21 ALSRP Therapeutic/Biomarker Trial Pilot Award (Funding Opportunity Number: W81XWH-21- ALSRP-TBPTA). For information about these 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 Clinical Development Award include, but are not limited to:

•         Using human subject-based resources to better define subtypes, predict therapeutic response, or assess prognosis. Biomarker development or data analysis may 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.

·         Correlating clinical trial-related biosamples, imaging, or epidemiological data with clinical outcomes.

·         Adding a biomarker companion or observational aim to an anticipated/ongoing clinical trial (standalone intervention clinical trials will not be supported).

·         Observational studies to optimize components of current established ALS multidisciplinary clinical care, such as respiratory care strategies, use of approved devices, or specific symptom management strategies and assistive technologies.

Early-career investigators and/or early-career physician scientists are encouraged to apply for the FY21 ALSRP Clinical Development Award.