UK patients, the healthcare system and the life sciences sector will benefit from a new scheme that will reduce the time it takes the Medicines and Healthcare products Regulatory Agency (MHRA) to approve clinical trials by more than 50% lower risk. .
The scheme is based on what is described in the MHRA. clinical trials consultation which was supported by 74% of those who responded. It forms an important part of the regulator's work. review of clinical trials regulationssupporting the government's ambition for the UK to be one of the best countries in the world to conduct clinical research for patients and researchers.
Initial applications for lower risk Phase 3 and 4 trials will be processed by the MHRA within 14 days rather than the statutory 30 days, provided the sponsor can demonstrate that the trial meets the requirements. MHRA criteriaeven confirming that there are no known safety problems with the drug under investigation.
Around 20% of initial clinical trial applications in the UK are expected to be eligible for the scheme. Requests for clinical trial modifications will not be eligible.
Dr June Raine, Chief Executive of MHRA, said:
โWe are excited to introduce this new optimized clinical trial system. Regulation of clinical trials should be flexible and proportional to risk, so that regulatory requirements are tailored to the risk posed by a trial.
โOur new notification scheme is exactly that. It will reduce the time needed to launch lower-risk clinical trials without undermining patient safety. This will help UK patients have quicker access to potentially life-saving drugs being studied.
"Our message to all clinical trial sponsors is that it is now in everyone's best interest to use the new scheme for all eligible trials."
Dr Janet Messer, director of approvals at the Health Research Authority, said:
โWe are delighted to support the MHRA with this new scheme. Combined review has already reduced the time needed to review clinical trials by half of what it was five years ago, and we are interested in exploring how the UK's fast-track Research Ethics Service can complement the new scheme. notification to further accelerate health and quality. social care research.
"We look forward to receiving feedback from the research community to ensure that together we continue to make it easier to conduct research that people can trust."
Steve Bates OBE, chief executive of the BioIndustry Association (BIA), said:
โIt is fantastic to see this simplified process being implemented for lower-risk late-stage trials, as Dr Raine discussed at the BIA Conference on the Future of UK Regulation last week. โThis is another move by the agency to accelerate clinical trial approvals and provide timely and effective service to the life sciences sector.โ
The opinion of a research ethics committee would still be a requirement for eligible trials.
The MHRA criteria for the scheme have been reviewed and endorsed by the government's independent expert scientific advisory group, the Commission for Human Medicines (CHM), the Clinical Trials, Biologics and Vaccines Expert Advisory Group (CTBVEAG). and representatives from trade associations, industry and academia. who have recently helped to support service delivery in clinical trials and research by ensuring that MHRA interventions are robust and that provision meets expectations.
The criteria for reporting clinical trials will remain under ongoing review and may be subject to change if there is evidence to support the need for this, including the possibility of extending the scheme to some medium-risk clinical trials.
