UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced its new framework for clinical trials, based upon the results of a consultation which collected more than 2,000 responses. The final goal of the revision, which comes 20 years after the last changes of UK’s clinical trial system, is to allow a faster and easier approval and to run clinical trials in the UK, so to increase the attractiveness of the country for clinical research. As highlighted in the “Government response to consultation on legislative proposals for clinical trials” document, the reform of the UK clinical trials regulatory framework will continue focusing on patients and their safety as the main objective of all clinical trials. These should become more proportionate, streamlined and flexible without compromising on safety. The reform is expected to integrate the regulatory and ethics reviews of clinical trial applications. For trials where the risk is similar to that of standard medical care, for example, the “notification scheme” will enable a clinical trial to be approved without the need for a regulatory review.
Faster times to recruit patients will also be part of the reform, based on the results of a pilot phase. The review process of applications should end up in a maximum 30 days in general, with maximum 10 calendar days for a decision to be granted once the regulator has received any final information. The new regulatory framework shall accomodate all different types of trials and innovative designs, including decentralised trials, and it will align to ICH Good Clinical Practice principles so to facilitate international multi-site trials. A legal mandate to register the trial in a World Health Organisation (WHO) public register, and a requirement to publish a summary of results within 12 months of the end of the trial would support transparency of the entire process.