The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is introducing a new system to speed up the approval processes for the lowest-risk clinical trials.
Under this new system, initial applications for Phase III and IV low-risk trials will be processed within 14 days, instead of the usual 30 days. The goal is to get treatments to patients quickly, without compromising safety.
The change comes from the MHRA’s clinical trials consultation where the UK government received feedback from over 2000 people, concluding that they will attract more international trials to the UK by making the application process faster and more efficient without sacrificing patient safety.
This change has the support of the government’s independent expert scientific advisory group the Commission on Human Medicines (CHM), and experts in medical and research fields, such as the Clinical Trials, Biologicals, and Vaccines Expert Advisory Group (CTBVEAG).
MHRA’s Chief Executive Dr June Raine said: “Our message to all clinical trial sponsors is that it’s in everyone’s best interest now to use the new scheme for all eligible trials.”
If the process is shown to be beneficial, it may be expanded to include some medium-risk trials in the future.
In March 2021, the MHRA launched a pilot programme to ensure that pharma companies and research teams harness the power of the patient voice. The scheme was reinforced by the MHRA Patient Involvement Strategy which was published in October of the same year.
Over a year later, the government published a document highlighting the progress that the strategy made, where they emphasised that patients were now involved in the early stages of new medicines, as well as using what patients say and their experiences to help conclude if a medicine is safe and beneficial.
The UK’s clinical trials landscape has taken a hit over the last few years, with a 44% reduction in patient enrolment and trial initiation since 2017. Brexit and Covid-19 are listed as two of the reasons why this may be the case, with regulatory barriers and strain on the National Health Service’s (NHS) resources. Incorporating patient’s voices in trial design may increase participation rates and patient involvement.
