What can we expect from the new era of clinical trials in the UK?

We consider the benefits of the amendments to the regulatory framework for the UK's Pharmaceuticals and Life Sciences sector.

Background to the regulations

The Government and the UK's medicines regulator, the MHRA (the Medicines and Healthcare products Regulatory Agency), have worked together for the past two years to produce draft proposals that update the Medicines for Human Use (Clinical Trials) Regulations 2004 (the Regulations). The draft proposals were based on feedback obtained in 2022 from a public consultation, which requested comments on how the regulation of clinical trials could be improved and strengthened in the UK. The amended regulatory framework was designed to align with Lord O'Shaughnessy's recommendations following the independent review of UK commercial clinical trials, published in May 2023, and the Government's response to those recommendations. One of the things emphasised in Lord O'Shaughnessy's report was that the UK has in recent years experienced a decrease in commercial clinical trials activity and falling numbers of clinical trials being initiated. The new regulations have been designed to attract researchers back to the UK by reducing the regulatory burden and addressing delays for trial approvals whilst still maintaining confidence and upholding participant safety.

The statutory instrument to amend the Regulations was laid before Parliament on 12 December 2024. Parliament will now debate the amendments and, pending successful progression through the parliamentary process, the new regulations are expected to come into force in early 2026 after a 12-month implementation period.

Purpose of the amendments

The new regulations are intended to encourage a more streamlined and flexible regulation of clinical trials (taking risk into account), removing unnecessary administrative burdens on trial sponsors, while protecting the interests of trial participants. According to the MHRA, the key changes will:

• Improve transparency: The registration of clinical trials in a World Health Organisation recognised public register will be a legal requirement under the new regulations. In addition, a summary of results will need to be published within 12 months of the relevant trial's conclusion. Within the research community, there has long been a move towards encouraging researchers to publish data from less successful or failed trials. Under the new regulations, researchers will have access to more data and findings. This will be a welcome change which will prevent costly repetition of work, allow studies to progress at a quicker pace and enable any negative data (such as in relation to side effects) to be better known.

To further facilitate improved transparency of clinical trial processes and data, it will also be a legal requirement to share trial findings with participants in a timely manner and in a language that is understandable. In this way, clinical trial information would be accessible, which would help to engender better protection of participant and patient interests.

• Simplify means of seeking and recording consent: In the case of "lower risk" trials, the amended regulations support the use of simplified means of seeking and recording consent. Lower risk trials involve medicines that have already been approved and therefore, in theory, pose minimal risk to participants. We can anticipate that a simpler approach to obtaining informed consent should speed up lower risk clinical trials. Simplification will be achieved by prescribers documenting consent in the participants' medical record rather than completing a written consent form.

• Support Research Ethics Committees: Research Ethics Committees (RECs) will benefit from greater flexibility to meet demand and respond to situations as long as they meet international standards. This change has been welcomed following feedback on the Regulations, which currently contain detailed requirements concerning the formation and function of RECs.

• Promote inclusion and diversity: The Health Research Authority (HRA) developed a draft set of questions on the topic of diversity and inclusion. The set of questions are intended for researchers to consider when they design clinical trials and clinical investigations to ensure that clinical research is designed to include people who could be impacted by the findings. Following receipt of the answers from members of the public and the research community, a new concept of an Inclusion and Diversity Plan has been introduced. The plan will be required where a sponsor or researcher intends to conduct a clinical trial.

The greater availability of data due to the requirement of greater transparency (explained above) will also enable researchers to better understand how diseases and medicinal products affect different groups and populations. This will support the tackling of health inequalities, and help improve treatment outcomes and access to healthcare.

Impact on the Pharmaceuticals and Life Sciences sector

Most notably, the new regulations are positioned to:

• Centralise the promotion of public health and place the protection of participants at the heart of legislation
• Support the evaluation and development of new or better medicines to benefit patients and society, and improve public health
• Remove barriers to innovation, while maintaining robust oversight of the safety of trials.
• Streamline the regulation of clinical trials and minimise burdens associated with running trials by utilising a risk-based approach
• Ensure that the UK remains a preferred location for multi-national trials by establishing legislation that enables trial sponsors to work across countries
• Increase transparency and access to data to support the reduction of health inequalities and maintain confidence in UK-based research

The combined review and notification scheme for selected clinical trial initial applications and amendments will be embedded into UK law. This puts it on a legislative footing which means that the assessment of clinical trial applications must be completed within statutory timeframes. This change will likely remove duplicative requirements and streamline the clinical trial process.

The HRA and MHRA are creating guidance to embed meaningful public involvement in clinical trials and increase the diversity of participants. The expected benefit of this approach is that the resulting research findings will be better able to support the development of universal medicines, addressing health inequalities caused by clinical data lacking in diversity. The UK is well-placed to address this issue given its worldwide reputation for the conduct of trustworthy and reliable research.

The HRA has made it clear in a recent update that trust has been an important factor when considering the reforms and that the new regulations aim to give confidence to people taking part in clinical trials in the UK. Accordingly, though clinical trial regulation will be made more streamlined and flexible, businesses should continue to consider the wider role they play in upholding public trust and confidence.

What can the Pharmaceuticals and Life Sciences sector take away from this regulatory update?

The amended clinical trial regulations could facilitate the modernisation of the research and development landscape, strengthening the UK's position as a prime destination for conducting innovative and safe clinical trials. The changes do present some benefits for businesses in the Pharmaceuticals and Life Sciences sector; therefore, we encourage businesses to take stock and equip themselves with the knowledge required to hit the ground running once the new regulations come into force.

Those in the Pharmaceutical and Life Science sector, and those involved in UK clinical trials, should prepare themselves for the suite of changes by:

• Keeping informed of updates to MHRA guidance published in anticipation of the changes.
• Considering ways that future clinical trial processes can promote health equity, which may involve incurring additional costs to design better studies and explore the nuanced differences in data relating to demographic groups.
• Updating clinical study document precedents in advance.
• Ensuring clinical trial agreements are reviewed and renegotiated as required.

We can support you in understanding the reforms and how your business should respond. Our specialist lawyers have expertise in reviewing and drafting clinical trial agreements, research and collaboration agreements, site agreements and laboratory services agreements. Though we expect the new regulations to come into force in early 2026, businesses should take action now to avoid disruption to their research projects and pipeline. It's never too early to prepare!

If you would like to discuss this article or would like to discuss how we might be able to assist you, please contact Alarna Bond-Farrell in our Pharmaceuticals and Life Sciences team on 07500 110580, or complete the form below.