The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is launching a pilot program to encourage inclusion of the patient voice in drug development that could, if successful, be expanded as part of the process in approving clinical trials.
MHRA said it will ask companies that submit applications for new active substances and indications to provide “evidence on the patient involvement activities they undertook when developing their product.”
Although, for now, it won’t request additional information on clinical trials, the agency said it “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.”
MHRA said it hopes to gain insight from any patient-related activities to assist with efforts to improve the quality of clinical drug development and patient outcomes.
The agency said information provided during the pilot program will be voluntary and not affect the outcome of a company’s application. But a successful pilot “will lead to patient involvement playing a greater role in the final assessment process,” MHRA said, “when clinical trials are approved or medicines are licensed.”
