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Deepa quotes the FDA: CDER communication with sponsors to implement SSDC (Selective Safety Data Collection)in appropriately identified trials will result in improved understanding of its real-world applicability, demonstration of its ability to facilitate efficient clinical trials, identification of potential challenges that programs encounter and ways to address those challenges, and promotion of best practices. As more sponsors pilot (Selective Safety Data Collection) SSDC in diverse therapeutic areas, the industry is gradually building an evidence base for: Improved patient retention through lower burden Reduced costs from fewer site visits and labs Faster recruitment due to simplified protocols Streamlined global trials enabled through regulatory harmonization Initiatives like FDAs Center for Clinical Trial Innovation (C3TI) Demonstration Program aim to promote cross-stakeholder collaboration and accelerate the uptake of (Selective Safety Data Collection) SSDC in industry (FDA C3TI, 2024)

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10.1080/02770903.2020.1781166 J Asthma

102 Beyzavi A, Nguyen N-T