Pilot finds value in inclusion plans for UK clinical trials
The Health Research Authority has published the results of a pilot in which seven clinical studies wrote an Inclusion and Diversity Plan, a document explaining how they will recruit a full range of the people who will use the treatment or device being tested. Participants found it useful to write the plan when a study is first designed, and the pilot showed that ethics committees need clearer information in these plans. Lawrence Tallon, chief executive of the MHRA, and Naho Yamazaki, deputy director of policy and partnerships at the HRA, both welcomed the findings. More researchers will be invited to volunteer for the scheme from early 2027.
This summary was generated by AI; the official source prevails.
What does it mean?
If you are taking part in a medicine or medical device trial, researchers may soon be asked to explain how they will include a fair mix of people. The plan is optional for now, so it does not change what trials must do under the law.
Who is affected?
Researchers, trial sponsors and ethics committees involved in clinical trials, and people who may take part in future trials.