March 2021: UK MHRA Pilots Patient Involvement In New Applications

The MHRA has announced a new pilot, which will request, on a voluntary basis, applicant companies of new active substances and new indications to provide evidence of 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.

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. As a partner, the MHRA is proud to be part of strengthening and contributing to this project.

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