From today, when new applications for selected medicines (new active substances and new indications) are received, the applicant company will be asked for evidence on the patient involvement activities they undertook when developing their product. For clinical trials, whilst additional information won't be requested at this early exploratory stage of the pilot, the MHRA will be documenting in medical assessment reports if there is evidence of patient involvement in clinical trial applications in order to better understand the current scope of activities.
In considering how patient involvement is integrated into the approvals process, the MHRA hopes to learn from any patient-related activities that take place during development, and use this knowledge to improve the quality of clinical drug development and health outcomes in the future.
During the pilot, the information provided by the applicants will be voluntary and will not alter the outcome of their application. However, in future, the Agency hopes that a successful pilot will lead to patient involvement playing a greater role in the final assessment process, when clinical trials are approved, or medicines are licensed.
Dr June Raine, MHRA Chief Executive, comments:
Patients are at the heart of everything we do. Gathering this information will help us gain a better understanding of the current landscape and give us important insight into the valuable work being done across our innovative life sciences sector.
I'm excited for the opportunity to learn more so that we can work together to shape the future of effective patient involvement and better outcomes for all.
Professor Matt Westmore, HRA Chief Executive, adds:
The HRA welcomes this initiative from the MHRA to ensure that new medicines are developed in partnership with patients. It complements our own work to support and encourage everyone involved in the development of clinical trials to work with patients beyond just recruiting them as participants.
This is crucial to ensure that studies are relevant, important and acceptable to take part in, so that high quality research can improve people's health and wellbeing. It is also more fundamentally just the right way to do research - it is about patient voice and patient power in the system.
The Agency will undertake a detailed analysis of the evidence submitted.
This crucial patient-focused pilot supports the ambitious vision of The Future of UK Clinical Research Delivery, launched today. As a partner, the MHRA is proud to be part of strengthening and contributing to this project.
