Post-Brexit Britain Aims to Match EU Rules on Trial Authorizations

The United Kingdom may be on its way out of the European Union, with all the downsides that the separation implies for medicines regulation. But the country is at the same time trying to harmonize at least its own domestic approach to clinical trial approvals, so as to align its practice with the EU’s new clinical trial regulation-whenever that comes into effect. It has set up a new single application route and a coordinated ethics and regulatory review leading to a single UK decision, and a pilot to embed the scheme has just notched up 100 such approvals. Sponsors and researchers are now being invited to consider the new streamlined route for reviewing their applications for clinical trials in the UK.

The scheme, known as the Combined Ways of Working (CWoW), provides a path to overcoming the regulatory differences that exist within the UK itself-where responsibilities for health are shared between England and the so-called devolved administrations: Scotland, Wales, and Northern Ireland. Within these somewhat tangled health structures, the UK drugs regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has been exploring with the Health Research Authority (HRA)-which was set up five years ago to promote the interests of patients and the public in health research-how to improve approval and management processes for clinical trials of medicines. Under the integrated approach that they have been experimenting with, researchers can benefit not only from a single submission, but also from combined communications to request any further information required, and a single communication to confirm the final decision.

The 100 approvals so far issued cover all phases development, including first-in-human studies, with applications from both commercial and non-commercial sponsors. The advantage is, say the organizers of the scheme, that a sponsor can expect a single UK decision in an average of 54 days, with even faster decisions for Phase I studies, compared with an average 91 days end-to-end timeframe for ethics review outside of the scheme. They claim that trial sponsors can plan their studies with more certainty as the timeframes are more consistent and predictable.

During the early stages of the pilot, which began in 2018, regulators and researchers focused on developing and testing new ways of working, but it quickly became apparent to participants that combined submission to the network of ethics committees and MHRA was the way to go. The scheme employs an integrated research application system, and associated software allows for individual case management systems to interact to assist the review process. The aim is also intended to help drug firms adapt to new ways of working, particularly those that split clinical trial authorization and ethics review between different departments.

The pilot has so far been open to applications by prior agreement only, but this is expected to be widened shortly. All MHRA Clinical Trials Unit assessors and 14 research ethics committees are now involved, covering the whole of the UK. And a single application dossier will then cover both the clinical trial authorization and the research ethics committee opinion (and in England and Wales this will also incorporate HRA and Health and Care Research Wales approval). 

“All this adds up to the most important benefit-helping innovative new medicines reach UK patients faster,” observes HRA piously, carefully avoiding any recognition that the access of UK patients to innovative new medicines will spring primarily from Britain’s withdrawal from the EU. “Increased integration is beneficial irrespective of the future regulatory landscape,” HRA concludes, in only the most veiled reference to the inevitable disruption.