April 6, 2023
UK Law Mandates Reporting Clinical Trial Results Within 12 Months
Clinical trials conducted in the UK must report their results within a year of completion or face penalties, as part of a series of new measures to be introduced by the Medicines and Healthcare products Regulatory Agency (MHRA).
The law is set to require all trials to be registered on a World Health Organization (WHO) public register unless a deferral has been agreed. Outcome sharing with patients will also be mandatory.
While there has been a law since 2013 requiring registration of trials within 12 months, it is not enforced in practice, with 8% of trials still not registered. This latest law is set to be extended to trials of medical devices and non-drug interventions, in a bid to hasten the advancement of science and expediate the delivery of promising new treatments to patients.
Biggest Changes in 20 Years
The requirement is part of a series of measures to make it easier to run clinical trials in the UK and is the first time in two decades the MHRA has made such an overhaul.
Under the new framework, clinical trial application processes in the UK will be more flexible to make the UK a more attractive destination for trials – including global “multi-site” trials. For example, the integration of the regulatory and ethics reviews of clinical trial applications, which reduced approval times by 50% in a pilot phase for studies and cut the time from application to recruiting a first patient by 40 days, will be embedded into the new regulation.
“Our world-first COVID-19 approvals showed how important it is to ensure that regulation is flexible and agile,” said MHRA Chief Scientific Officer Marc Bailey in a press release.
“This overhaul of the clinical trials legislation will do just this—it 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,” he added.
Our world-first COVID-19 approvals showed how important it is to ensure that regulation is flexible and agile.
Chief Scientific Officer at MHRA
The measures come just a few weeks after the government commissioned an independent review into the country’s clinical trial landscape after a report showed the UK suffered a 41% decline in trials between 2017 to 2021. The goal of the review is to offer recommendations on how to increase UK growth and investment, encouraging pharmaceutical companies and research organizations to conduct trials in the UK. The review is set to be published in the spring of 2023.