What question did this study set out to answer?

To evaluate the variability and evidentiary strength of pivotal trials for drug approvals by the European Medicines Agency from 2020 to 2023.

Evidence supporting European Medicines Agency drug approvals (2020–2023): A cross-sectional study of trial design and outcomes

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To evaluate the variability and evidentiary strength of pivotal trials for drug approvals by the European Medicines Agency from 2020 to 2023.
Conducted a cross-sectional analysis of pivotal trials for drug approvals.
Assessed trial designs, including prevalence of randomized controlled trials and surrogate endpoints.
Reviewed primary endpoints of trials to gauge regulatory thresholds.
Majority of trial designs were randomized controlled trials.
Surrogate endpoints were frequently used, indicating a reliance on indirect measures of effectiveness.
10% of drug approvals resulted from trials that did not meet primary endpoints, reflecting regulatory discretion.

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This cross-sectional study shows variability in trial designs and outcomes in drug approvals, suggesting a need for clearer evidence standards.

Siebert et al. (2026) studied this question.

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This cross-sectional study shows variability in trial designs and outcomes in drug approvals, suggesting a need for clearer evidence standards.