SA30 Evaluation of National Approvals and Data Collection Durations in Retrospective Noninterventional Medical Record Review Studies Conducted in the United States (US), Canada, Europe (EU), and Asia

M Sluga-O'Callaghan,V Derrien Ansquer, G Frugier,K Houghton

Value in Health(2022)

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摘要
Real-world data is playing an increasingly important role in clinical research and healthcare decision making. To inform real-world evidence generation strategy planning, our aim was to document approval/classification durations (ACD) and overall data collection duration (DCD) in retrospective, noninterventional medical record review studies (MRRs) conducted in North America, EU, and Asia.
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关键词
national approvals,data collection durations,evaluation,studies
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