The consistency of the US FDA’s web of guidances and precedents around the use of real-world evidence of efficacy helped Aetion construct a simple regulatory feasibility screening instrument addressing topics from the importance of established natural history to the need for objectively measurable primary endpoints that can help sponsors determine if an RWE-based strategy is worth pursuing.
Finding The Sweet Spot For Real-World Evidence: Aetion Stresses Early Feasibility Assessment
Robust natural history data sets with well-chosen outcomes are fundamental in Aetion’s regulatory feasibility tool for real-world evidence, built through analysis of US FDA case studies and guidance.
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