ProPharma applauds the myriad of recent, positive developments for clinical trials in the UK, representing the biggest overhaul in UK clinical trials in two decades.
The Association of the British Pharmaceutical Industry (ABPI) has reported that in the last five years, participation in commercial clinical trials has dropped by 44%. The count of new clinical trials has reduced by 41% between 2017 and 2021.
In order to identify causes as well as solutions, the government appointed Lord O’Shaughnessy to conduct an independent review of the UK clinical trial environment, building on the government’s 10-year plan "Saving and Improving Lives: The Future of UK Clinical Research Delivery", published in March 2021 and will also take into consideration the work of the Recovery Resilience and Growth (UK RRG) programme. Lord O’Shaughnessy is a Senior Partner at consultancy firm Newmarket Strategy, Board Member of Health Data Research UK (HDR UK), and former Health Minister.
A publication of findings is expected for Spring 2023 and ProPharma will provide an in-depth analysis.
The Chancellor recently announced the UK’s Spring Budget, indicating that a total of £10 million over the next two years has been awarded to the Medicines and Healthcare Products Regulatory Agency (MHRA). The additional funding will further the effort to provide patients with fast-track access to best-in-class medical products. It will also support the establishment of an international recognition framework, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners. Lastly, the new budget will be utilised for a more thorough and expedited approval process for cutting-edge treatments created in the UK in order to provide the UK’s healthcare urgencies, e.g. a vaccine for cancer vaccines and AI-based therapeutics.
Alongside Lord O’Shaughnessy’s Clinical Trial sector review, a public consultation conducted between January 17th, 2022 and March 14th, 2022 is establishing the foundation for a once in a generation overhaul of the legislative framework underlying clinical trial conduct in the UK.
With the aim to create a new global benchmark for transparency in research, the UK government, alongside the UK regulator MHRA have published a set of legislative changes:
All clinical trials will have to be registered in a public World Health Organisation (WHO) registry. This had been a UK regulatory requirement since 2013, however enforcement was largely toothless resulting in 8% of clinical trials in the UK trials still not being registered.
Results of all clinical trials are to be made public within 12 months of the end of the trial. Whilst this is already best practice, the new framework will make it enforceable, sanctioning any non-compliant company or university.
A detailed overview of the new process and requirements are yet to be finalised; however, they are likely to follow the examples mirrored by EU and US frameworks. The legislation will also make provision for the possibility of exemptions, where justified. This will curb wastefulness in taxpayer-funded research, reduce data fraud and substantially accelerate the translation of new discoveries into improved patient care.
UK Government and MHRA are determined to afford the new framework sufficient consequence to illicit compliance with an eye on regulators across the European Union who gained legal powers to enforce transparency requirements in 2022.
Non-compliant companies and universities are facing grounds for non-acceptance of a request for authorisation for any future clinical trial. This will drastically further the UK’s international standing where the US FDA has yet to impose a single sanction on sponsors who violate a 2007 transparency law.
The new legislative initiative aims to create a proportionate and flexible regulatory environment with the patient’s safety at heart. To achieve this, the combined regulatory and ethics review will be embedded into the new framework. In its pilot phase it had halved clinical trial approval times and reduced the time from application to first patient recruited by 40 days.
Moreover, low-risk and cluster trials will utilise simplified approval procedures and face a lower consent burden with the aim to be responsive to different types of trials and innovative designs. This will foster new simplified, responsive, and innovative ways of carrying out trials, ensuring the UK remains one of the most attractive clinical trial destinations for sponsor organisations.
In the coming months, the UK government will prepare the legislative proposal and the MHRA accompanying guidance documents. This new legal framework will be a major victory for patients in the UK, setting a new global standard for transparency with the hope to have the world benefit from discoveries made in the UK.
ProPharma takes pride in our team of outstanding UK clinical trial consultants with a uniquely diverse collection of backgrounds and skills – from science and medicine, to politics, law and international relations – with one mission in mind: translating an ever more complex world into success for our clients’ drug development programmes. Be part of this new era of UK Clinical Trials. Reach out to us today and let us unlock your scientific potential.
July 17, 2023
Decentralized clinical trials (DCTs) have emerged as a transformative approach in clinical research, offering unique benefits that challenge the traditional models. However, deciding whether to...
September 12, 2023
In the ever-evolving landscape of clinical trials disclosure, navigating the intricacies of registration, compliance, and ethical transparency has become more crucial than ever. Pharmaceutical and...