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While RCTs remain the gold standard for demonstrating efficacy, they are limited by the time they take, their costs and their limited external validity.7 One of the main problems with conventional RCTs is often restrictive eligibility criteria, which limits the generalisability between clinical trial populations and the target population.14 Although RRCTs can reduce the problem of generalisability, the extent to which this occurs is dependent both on characteristics of the registry and design of the embedded clinical trial.14 The advantages and disadvantages of RRCT are listed in table 2

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doi:10.1038/s41392-022-00904-4 US Food and Drug Administration

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