Replacing RCTs with real world data for regulatory decision making: a self-fulfilling prophecy?

Beate Wieseler,Mattias Neyt,Thomas Kaiser,Frank Hulstaert, Juergen Windeler

BMJ (Clinical research ed.)（2023）

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摘要

Real world data are advocated as an alternative approach to RCTs for closing knowledge gaps on drugs, but Beate Wieseler and colleagues argue that this approach is the wrong remedy for current challenges in drug development

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关键词

regulatory decision,rcts,decision making,real world data,self-fulfilling

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