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Awareness underscores the value of real-world data, and patient-reported outcomes in deepening understanding of rare disease biology, progression, and patient needsfilling knowledge gaps that often hinder therapeutic progress

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The FDA's December 2023 DCT guidance explicitly validates telemedicine visits as acceptable investigator-subject interactions for the majority of non-safety-critical protocol assessments, including symptom review, adverse event follow-up, protocol compliance discussions, and patient-reported outcome elicitation