Evaluation of the Medicines and Healthcare products Regulatory Agency's introduction of a risk-proportionate approach for clinical trials: An analysis of 4617 applications assessed between September 2023 and August 2024.

Aims: The Medicines and Healthcare products Regulatory Agency (MHRA) introduced a risk-proportionate approach to assess clinical trial applications for authorisation in August 2023. This study evaluates the impact of this approach on the timelines for reviewing proposals.

Methods: Data on new clinical trial initial submissions and substantial amendments were extracted from the MHRA's clinical trials unit database. The primary endpoint was the number of days for the MHRA's first review of initial applications. The secondary endpoints were the days taken by the sponsor's replies to grounds for nonacceptance, the MHRA's days to issue the final decision and the percentage of reviews within statutory timelines. For substantial amendments, the days for the final decision and the percentage of statutory timelines met were the endpoints.

Results: Between September 2023 and August 2024, 4617 applications were received, 615 relating to initial clinical trial submissions, while 4002 were substantial amendments. The first review was completed within the statutory timelines for 99% of submissions, with a median of 28 days (interquartile range [IQR] 27-30); 48.5% of sponsors' replies to grounds for nonacceptance met the statutory timelines with no statistically significant difference between the commercial and noncommercial sponsors (median 15 days, IQR 9-22). The final decision from the MHRA was within the nonstatutory timelines (median 15 days, IQR 13-27); 99.9% of the substantial amendments were completed within the statutory timelines (median 31 days, IQR 24-34).

Conclusion: The MHRA's risk-proportionate approach enabled the Clinical Trials Unit to consistently meet its timelines, confirming its reliability, consistency and predictability while maintaining its priority to protect patient safety.