MHRA seeks input on using EHR data to inform clinical trials

The UK’s healthcare regulatory body is seeking input on how to better use data from electronic health records to inform clinical trials.

The Medicines and Healthcare products Regulatory Agency (MHRA) is asking stakeholders to help shape new guidance that outlines how greater use of real-world data in clinical trials could help transform the availability of cost-effective treatments.

The innovative use of real world data can help bring life-changing new medicines to those who need them sooner, the MHRA said in a statement.

The regulator launched a consultation on the guidance on 30 October.

Information electronic health records, disease and patient registries is frequently used to monitor the safety of medicines and medical devices after they have gained approval but is rarely used to help demonstrate the effectiveness of an intervention before it is approved.

The MHRA hopes this data could be used to demonstrate the effectiveness of medicines and medical devices sooner.

Dr Siu Ping Lam, MHRA director of licensing, said: “When used in this innovative way, real world data has the potential to make a huge difference when it comes to bringing medicines from clinical trials to patients.

“With fewer or no trial-specific visits, consenting trial participants don’t have to travel long distances to get to their appointments. And with fewer logistical hurdles, real world data could make it more feasible for trial sponsors to repurpose existing medicines for new conditions – with the potential to save the NHS millions of pounds.

“Because of this, and the growing need to find more cost-effective ways of conducting clinical trials, our new draft guidance focuses on how to use real world data to gain regulatory approval, helping to bring medicines to the patients who need them, sooner. We look forward to hearing people’s thoughts.”

You can read the draft guidance and provide feedback here.