We have responded to a Medicines and Healthcare products Regulatory Agency (MHRA) consultation on a new revision to the International Council for Harmonisation (ICH) E6 (R3) Good Clinical Practice (GCP).
ICH GCP is an internationally recognised ethical and scientific standard that should be followed when designing, conducting, recording and reporting clinical trials that involve people.
ICH E6 (R3) has been updated to address its application to new trial designs, technological innovations and its application for clinical trials of medicines to support regulatory and healthcare decision making.
The MHRA consulted directly with UK stakeholders to compile and co-ordinate their comments to the ICH Expert Working Group.
In our response to the consultation, we highlight the importance of public involvement in the design and development of clinical trials to improve their quality and relevance.
This includes a focus on public involvement:
- when developing research participant information materials to meet the needs of all study participants
- when developing consent materials to ensure they are accessible
- to support the ethical review process
- to help recruit and retain study participants
In our response to the consultation, we also provide guidance on appropriate oversight from the study principal investigator.
Clive Collett, Head of Policy and Engagement at the HRA“We are very pleased to respond to this consultation which will help ensure that the GCP is applied in the right way to clinical trials in the UK.
“We would like to see the role of public involvement strengthened in GCP. Public involvement means that patients and people with relevant experience contribute to how the research is designed and conducted.
“Public involvement is really important as research teams that involve patients and the public run better studies.”
The consultation opened in November 2024 and closed in February 2025.