UK to merge trial regulatory and ethics reviews in study rules overhaul

The MHRA says combining regulatory and ethics reviews for trials will speed start-up and make the UK more attractive for drug research.

The UK drug regulatory made the claim when announcing a wider plan to revamp the rules governing medical research in what it described as the biggest overhaul of trial regulation in 20 years.

The Medicines and Healthcare and products Regulatory Agency (MHRA) cited the results of a pilot study in which regulatory and ethics reviews were integrated, explaining the approach halved approval times for studies and cut the time from application to recruiting the first patient by 40 days.

It also said it plans to introduce a 30 deadline for reviewing clinical trial applications with a “maximum 10 calendar days for a decision to be granted once the regulator has received any final information.”

The revamp –which follows a consultation conducted with the Health Research Authority (HRA) and the Department of Health in Northern Ireland – also addressed transparency.

The changes will also introduce a legal mandate to register trials in a World Health Organization (WHO) public register and to publish a summary of results within 12 months of the end of the study.

Clinical decisions

The MHRA said the planned changes will create a framework that is “future-proof” and flexible enough to accommodate innovative designs, including decentralized trials.

Marc Bailey, MHRA chief science and innovation officer, said overhauling clinical trial legislation “will move us away from a one-size-fits-all approach to the regulation of clinical trials and help to streamline approvals by removing granular and duplicative regulatory requirements.”

Bailey added “This will make the UK one of the best countries in the world to conduct clinical research and, get innovative medicines to the people who need them faster.”

Earlier this month the UK Government said it would review the clinical trial landscape in a bid to reverse what the ABPI has called a “worrying decline” in drug research in the UK.

The MHRA said its planned revamp is in line with the review, which is being conducted by Conservative member Lord James O’Shaughnessy – founder of medical consulting group Newmarket Strategy.

The MHRA’s plan comes shortly after the government announced additional funding of £10 million ($12 million) for the agency “to accelerate the delivery of cutting-edge treatments including cancer vaccines.”

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