DOD Amyotrophic Lateral Sclerosis, Pilot Clinical Trial Award

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The FY23 ALSRP Pilot Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of Amyotrophic Lateral Sclerosis (ALS). Projects may range from phase 1 to small-scale phase 2 trials and should aim to de-risk and inform the design of more advanced trials by investigating safety, feasibility, biomarker application, and therapeutic efficacy in relevant patient populations. Clinical trials may be designed to evaluate promising drugs, biologics, or devices with anticipated therapeutic impact that is supported by strong scientific rationale and existing preliminary studies and/or preclinical data. Potential impact is not whether a therapy is ready at the conclusion of the trial, but rather if the outcomes will improve and accelerate future larger trials. Applications submitted to this award can have outcomes that focus on specific subpopulations of ALS patients or potentially even individual patients. Applicants not investigating a therapeutic but proposing a clinical trial to optimize established ALS clinical care must submit under a lower total direct cost Clinical Care Tier. Examples of efforts that will be supported under this tier include but are not limited to optimization of respiratory care strategies, improvements to approved devices and assistive technologies, specific symptom management strategies, and/or telemedicine strategies. The capacity for near-term impact on patient care is an important component of the Clinical Care Tier.

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