MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions

Following a 6-week consultation, the MHRA has issued guidance outlining how greater use of real-world data (e.g. electronic patient health records; disease and patient registries) for clinical trials could help expedite the availability of cost-effective treatments.

Source:

Medicines and Healthcare products Regulatory Agency

Resource links:

MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions

MHRA guideline on randomised controlled trials using real-world data to support regulatory decisions