DoD Amyotrophic Lateral Sclerosis Clinical Development Award

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The intent of the FY20 ALSRP Clinical Development Award mechanism is to support studies leveraging human-based ALS resources to enrich clinical trials, in addition to projects designed 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. Examples of human-based 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. The resources must be available at the time of application submission. Collection of specimens and/or data at additional time points 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/default). Other resources may be used, provided a letter of support adequately describes the relevant repository parameters and mechanisms for broad access to data and samples. 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 • Correlating clinical trial-related biosamples, imaging, or epidemiological data with clinical outcomes • Adding a companion aim/goal to an anticipated/ongoing clinical trial, not otherwise supported by the trial • Studies to evaluate optimizing components of current established ALS multidisciplinary clinical care such as respiratory care strategies, use of approved devices, or specific symptom management strategies

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