UK patients, the healthcare system and the life sciences sector are set to benefit from a new scheme that will see the time taken by the Medicines and Healthcare products Regulatory Agency (MHRA) to approve the lowest-risk clinical trials reduced by more than 50%.
The scheme is based on that outlined in the MHRA's clinical trials consultation which was endorsed by 74% of those who responded. It forms a significant part of the regulator's overhaul of the clinical trials regulation, supporting 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 the lowest-risk Phase 3 and 4 trials will be processed by the MHRA within 14 days instead of the statutory 30 days, provided the sponsor can demonstrate the trial meets the MHRA's criteria, including by confirming there are no known safety issues with the medicine being investigated.
About 20% of UK initial clinical trial applications are expected to be eligible for the scheme. Applications for clinical trial amendments will not be eligible.
Dr June Raine, MHRA Chief Executive said:
"We are excited to introduce this new streamlined clinical trials system. Clinical trials regulation should be flexible and risk-proportionate so that the regulatory requirements are geared to the risk that a trial presents.
"Our new notification scheme is exactly that. It will reduce the time taken to get the lowest-risk clinical trials up and running without undermining patient safety. This will help give UK patients quicker access to the potentially life-saving medicines being studied.
"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."
Dr Janet Messer, Director of Approvals at the Health Research Authority said:
"We're delighted to support the MHRA with this new scheme. Combined review has already reduced the time taken to review clinical trials to half what it was five years ago, and we're keen to explore how the UK's fast-track Research Ethics Service can complement the new notification scheme to further accelerate high quality health and social care research.
"We look forward to feedback from the research community to make sure that together we continue to make it easier to do research that people can trust."
Steve Bates OBE, Chief Executive Officer of the BioIndustry Association (BIA), said:
"It is great to see this streamlined process for lower-risk late stage trials rolled out, which Dr Raine commented on at the BIA Future of UK Regulation Conference last week. This is another measure by the agency to speed up clinical trial approvals and provide a timely and effective service to the life sciences sector."
An opinion from a research ethics committee would remain a requirement for eligible trials.
The MHRA's criteria for the scheme has been reviewed and endorsed by the government's independent expert scientific advisory group the Commission on Human Medicines (CHM), the Clinical Trials, Biologicals 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 investigations by ensuring the MHRA interventions are robust and that delivery meets expectations.
The criteria for notification of clinical trials will be kept under continual review and may be subject to change if evidence is there to support the need for this, including the potential to expand the scheme to some medium-risk clinical trials.
Notes:
- To apply for the scheme, please visit our website
