ArticleBritish journal of clinical pharmacology2026
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.
Article in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Oncology drug development in the UK: analysis of the past 25 years and focus on the 2026 reboot of the clinical trial regulatory framework.British journal of cancer · 2026Article
- 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.British journal of clinical pharmacology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThe 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.
methodsData 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.
resultsBetween 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).
conclusionThe 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.