The Policy Exchange has come up with a report that highlights the potential benefits of The Future Clinical Trials Bill when it comes to improving UK’s approach in case of establishing and regulating clinical trials.
The new bill is one of several proposed policies that will be executed under the new legislative programme, which will be presented in the final session of this Parliament.
Future clinical trials bill offers several benefits
The main idea of the bill is to enhance patient engagement and also prioritise safety in clinical trials, while at the same time promoting a better flexible regulatory approach, as stated by the author. If this goal gets accomplished, it would enhance UK’s competitiveness as a prominent global destination in case of conducting trials.
As per Iain Mansfield, the author of the report and who also happens to be the Director of Research and Head of Education and Science at Policy Exchange, the Future Clinical Trials Bill is crucial as it addresses the existing challenges that limit the conduct of clinical trials throughout the UK. To be able to successfully deliver these trials, certain actions must be taken, like improving clinical trial set-up, design, as well as regulation, with a focus on achieving faster as well as more flexible processes.
Mansfield specified that UK’s approach has always been regarded as slow and this study was conducted by the Association of the British Pharmaceutical Industry- ABPI in 2022. The study revealed that between 2018 to 2020, there was a almost one-month rise in the average time it took for a participant in a trial to receive their first dose after applying for regulatory approval.
Mansfield pointed out that Spain has made substantial advances in recent years. This progress can be attributed to the introduction of legislation that enforces strict timelines for approval. It is well to be noted that within one year of the legislation being implemented, the average timeframes for setting up trials were reduced by 15%.
Mansfield provided a comprehensive list of the key components outlined in the Future Clinical Trials Bill, such as these:
- The legislation aims to update the Medicines for Human Use (Clinical Trials) Regulations 2004, which happen to be based on the EU Clinical Trials Directive.
- There are several provisions that can be implemented to ensure greater transparency.
- To register trials, it is necessary to go through the Health Research Authority, which then proceeds to register the trials with the ISRCTN Registry, which is the primary and internationally recognised clinical trial registry recognised by the WHO.
- It is necessary to publish a summary of the trial results within twelve months after its completion in order to promote future participation. This is only applicable if a deferral has been agreed upon.
- The National Institute for Health and Care Research (NIHR) should be mandated to collect and publish monthly reports on NHS clinical trial activity nationwide. This activity aims to consolidate the relevant data sets collected by both the MHRA and the HRA.
Regulatory pragmatism in the context of clinical trials
A new time limit of sixty days will be introduced for trial participants to answer Requests for Further Information- RFI from the MHRA or Research Ethics Committee- REC. According to the report, this would allow sponsors enough time to prepare responses that meet the requirements of regulators.
The report acknowledged that the bill would implement a notification scheme for low intervention trials and would eliminate the need to report individual Suspected Unexpected Serious Adverse Reactions (SUSARs) to all trial investigators.
According to Mansfield, the provisions of the Future Clinical Trials Bill will require transparent trial registration and help expedite the approval process.