MHRA launches patient involvement pilot for drug applications

The UK drugs regulator is now asking that all applications for new medicines or indications detail the efforts made to involve patients in the drug development process. 

The voluntary scheme by the Medicines and Healthcare products Regulatory Agency (MHRA) aims to inject a dose of “patient centricity” into medicines development – something that has been talked about by the pharma industry for years but arguably hasn’t yet become an intrinsic part of the process.

It applies to marketing applications for all new active substances or new indications and could be extended to include new clinical trial applications after an initial “exploratory” phase, according to the regulator.

Even now, however, the MHRA will be “documenting in medical assessment reports if there is evidence of patient involvement in clinical trial applications”.

The objective of the pilot is to learn how patient involvement activities can be deployed to improve the quality of the drug development process and ultimately the benefits offered to patients.

In future, the hope is that it may encourage a higher level of patient involvement in its final assessment of whether clinical trials are approved or drugs are licensed.

“Gathering this information will help us gain a better understanding of the current landscape and give us important insight into the valuable work being done across our innovative life sciences sector,” said MHRA chief executive Dr  June Raine.

There are many reasons for making sure patients have a say in new medicines development, not least that their views can often improve the chances of a new therapy providing improved health outcomes that support approval and clinical use.

A poorly designed trial that doesn’t take patients’ needs into account could suffer from poor subject enrolment and retention, for example, and collaboration with patient organisations early on in the development can help sidestep that issue.

Likewise, patients can help developers identify the endpoints to measure in a trial that could show the greatest impact on their lives, and provide input on other factors like whether the dosing of a new therapy is appropriate, or if remote studies and digital technology could be useful, for example in reducing or eliminating the need to travel to a specific investigation site.

The MHRA initiative has been welcomed by the Health Research Authority, which oversees NHS research in England.

HRA chief executive Professor Matt Westmore said the pilot “complements our own work to support and encourage everyone involved in the development of clinical trials to work with patients beyond just recruiting them as participants”.

“This is crucial to ensure that studies are relevant, important and acceptable to take part in, so that high quality research can improve people’s health and wellbeing,” he added.

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