Presents approaches to address challenges in ALS trials, including patient recruitment, restrictive protocols, and high attrition. Discusses regulatory guidance encouraging patient input, adaptive design, and decentralized trial models. Highlights platform trials, precision dosing, and subpopulation optimization as strategies to increase success rates. Recommends leveraging real-world data, social listening, and patient advocacy groups to enhance recruitment. Emphasizes designing protocols that reduce burden, accommodate mobility needs, and support compassionate use programs.

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