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MHRA Project Prioritises Patient Involvement in New Clinical Trial Applications

on Tuesday, 18 May 2021.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a pioneering new pilot which seeks to make patient involvement in clinical trials a priority.

For all new applications for selected medicines (new active substances and new indications), the MHRA will be asking applicants to include evidence on the patient involvement activities undertaken when developing the product. The information is to be provided on a voluntary basis at this time.

The MHRA has confirmed that whilst this evidence will not be required at early exploratory stages of product development, it will still be noting whether there is evidence of patient involvement in these early stage trials in order to supplement its understanding of the use of such activities.

Pilot Project Objectives

The goal of the pilot is to teach the MHRA about the patient-related activities which clinical trial sponsors are using and utilise this information to improve drug development and health outcomes. If the pilot is successful, the MHRA hopes to see patient involvement take a greater role in clinical trials.

The pilot is part of the Government's vision laid out in the recent policy paper publication 'The Future of UK Clinical Research Delivery', which aims to "unleash the full potential of clinical research delivery to tackle health inequalities, bolster economic recovery and to improve the lives of people across the UK".

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