MHRA and HRA publish findings from clinical trial inclusion and diversity plan pilot
The Health Research Authority and the Medicines and Healthcare products Regulatory Agency have published findings from a six-month pilot testing Inclusion and Diversity Plans for clinical research. Held in 2025, the pilot involved seven studies, including five phase 3 trial applications and two medical device tests. Researchers submitted a plan showing how they would recruit a representative group of patients to receive ethics committee reviews. The agencies reported that researchers found value in creating these plans while designing their trials. However, the pilot showed that guidance formatting and information presentation for committees need refinement. The agencies updated the guidance based on this feedback. Beginning in early 2027, the Health Research Authority will run a broader 12-month voluntary phase with a select group of ethics committees. Participation remains optional, as submitting a plan is not a legal requirement. Testing medicines across varied patient groups helps researchers understand how care options work across different populations.
What was announced
The Health Research Authority (HRA) published pilot results evaluating Inclusion and Diversity Plans for UK clinical trials and investigations. The pilot ran for six months in 2025. It tested draft guidance produced jointly by the HRA and the Medicines and Healthcare products Regulatory Agency (MHRA).
Seven studies participated in the pilot. Five were phase 3 trials for investigational medicinal products, while two focused on medical devices. Both commercial and non-commercial sponsors participated. Each participant submitted an Inclusion and Diversity Plan alongside their application for a Research Ethics Committee (REC) review.
The pilot yielded three main findings:
- Researchers and sponsors saw benefits in drafting a plan during the initial study design phase.
- RECs need clearer presentation regarding the details contained in the plans.
- The layout of the guidance requires refinement to help users find relevant information easily.
The guidance has been updated to address these points. Starting in early 2027, the HRA will invite researchers to volunteer plans in a 12-month trial using a limited set of RECs.
What it means
Inclusion and Diversity Plans outline how trial sponsors aim to recruit diverse participant groups. These groups match the populations expected to use the tested drugs or medical devices.
When trial populations reflect actual patient populations, trial evidence becomes more relevant. Naho Yamazaki, Deputy Director of Policy and Partnerships at the HRA, stated that diverse participant groups provide a clearer understanding of how treatments, devices, and care affect different people. Lawrence Tallon, Chief Executive of the MHRA, stated that generating representative trial evidence helps support healthcare research both in the UK and internationally.
Submitting a plan remains voluntary. It is not a legal obligation under the UK clinical trial regulations introduced in April.
What the announcement does not tell us
The announcement leaves several operational details unclear. It does not name the seven sponsors or research teams that took part in the 2025 pilot. It also does not specify which RECs will review plans during the 12-month trial phase starting in early 2027.
The document does not detail how ethics committees will evaluate inclusion plans or whether specific recruitment targets will be required. Furthermore, the announcement does not state if or when Inclusion and Diversity Plans might become mandatory for all UK clinical trial applications.
How this was written
This analysis was written with AI from the official announcement below, using only facts that announcement states. The quoted wording is gov.uk: Medicines and Healthcare products Regulatory Agency’s own. Always check the original before acting on anything here.
The Health Research Authority (HRA) has published the findings from its pilot on researchers and sponsors of clinical trials and clinical investigations developing and submitting an Inclusion and Diversity Plan.
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