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

BMJ

2 March 2023 - Real world data are advocated as an alternative approach to randomised clinical trials 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.

Attempts to accelerate the provision of new treatments have led to evidence that is limited in quantity and quality being submitted for regulatory approval in recent years.

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Michael Wonder

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Michael Wonder