The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the launch of a pilot project aimed at ensuring patient involvement in clinical trials and medicines development.
This project only applies to new applications for medicines with new active substances and/or new indications. On submission, an applicant will be asked to provide evidence of the patient involvement activities they undertook during product development. However, at this stage of the pilot, the MHRA will not be requesting such information as it applies to clinical trials. It will instead document any instances of patient involvement in clinical trial applications in order to better understand the current scope of these activities.
It is also important to note that participation in this pilot is voluntary. The MHRA will simply ask for this information and the outcome of an application will not be affected by an applicant’s unwillingness to take part in the pilot.
The MHRA is hoping the pilot will inform them of the current state of patient-related activities during drug development with the aim of improving clinical drug development and consequently long-term health outcomes. This pilot has been launched on the same day that The Department of Health and Social Care released their vision for the future of UK clinical research delivery. One of the 5 key themes of this vision is patient-centred research, something that the MHRA’s pilot will help to develop.
The MHRA intends that this pilot will lead to patient involvement playing a greater role in drug development in the future, particularly with regards to the final assessment process of clinical trials and medicines licensing.
For more information on this latest initiative, click here.