World Clinical Trials Day 2025: No Trial Drug Left Behind – And No Patient Left Out
Posted on: Tuesday 20 May 2025
Author: Dr Kirsty Wydenbach FFPM et al
Each year on 20 May, the global clinical research community comes together to mark World Clinical Trials Day. This commemorates James Lind’s 1747 scurvy trial, which is widely regarded as the birth of modern clinical research. Even though trial methodology has come a long way, as we celebrate this legacy today we must also examine our present practices to reimagine a more inclusive, efficient, and equitable future for clinical trials.
In 2025, our focus must go beyond what has been achieved – we must address what is still being left behind: trial drugs with unfulfilled potential and populations underserved by research.
A Turning Point for UK Clinical Research
This year marks a transformative moment in the UK’s research landscape. On 11 April 2025, the UK Government signed into law[1] a new set of clinical trials regulations, following extensive public and industry consultation, and several years of work. The reforms, led by the MHRA, come into force on 28 April 2026 and are underpinned by five core principles:
- Put patients and their safety at the focus of all clinical trials and bring the benefits of clinical trials to everyone.
- Cut duplication and unnecessary delays, while maintaining robust oversight of the safety of trials.
- Create a proportionate and flexible regulatory environment, reducing bureaucracy for lower-risk trials.
- Cement the UK as a destination for international trials.
- Provide a framework that is streamlined, agile and responsive to innovation.
- These regulations have the potential to place the UK at the forefront of global clinical research – prioritising both speed and scientific rigour – and reinforce the MHRA’s vision of “the right trials, in the right patients, at the right time.”
We now eagerly await the accompanying guidance, although the Health Research Authority (HRA) has already started to outline the changes[2] from an ethics perspective, including a summary of the key changes to the current legislation.
Underrepresented Populations in Trials
As we accelerate the pace of innovation, we must not overlook who is being left out. In the same article that outlines the new changes, the HRA highlights the need for diversity and inclusion in clinical trials. For example, a recent Guardian article (May 2025[1]) specifically highlighted a “concerning lack of female-only medical trials” in the UK. Despite decades of advocacy, women remain underrepresented in many trial cohorts, especially in research exploring female-specific conditions, hormone therapies, and female-specific responses to medications. Health experts stated that the omission of underrepresented groups in clinical research may threaten both safety and equity. Without data derived specifically from diverse groups, who may have a higher disease burden for certain disease or be impacted greater by the research findings, the true efficacy and safety of medicines remains unclear – a gap that can lead to delayed diagnoses, misinformed treatment decisions, and overlooked adverse effects. Whilst this article focused on women there is a far wider reaching list of underserved populations in clinical trials, including (but very much not limited to!) the elderly (particularly those aged over 75 years), ethnic groups, those with disabilities, neurodiverse people and different socioeconomic backgrounds.
The new MHRA regulations aim to rectify this by embedding inclusivity and diversity into trial design. However, real change will require ongoing accountability and diverse recruitment strategies. It will also need cultural shifts in research priorities, including greater use of population based and real-world trials, potentially matched with genomic analyses to examine differential responses within populations. The integration of Artificial Intelligence (AI) systems into clinical research is also an important opportunity to accelerate progress, covering key areas such as patient identification to ensure diversity and synthetic control arms, but with far-reaching implications recognised by EU regulators[2]. We should also not forget that direct patient and public engagement and involvement in the whole of drug development and the healthcare chain is invaluable at identifying and hopefully rectifying all these areas of unmet need. Research ‘for patient benefit’ should be pivotal in all trials through to day-to-day delivery of NHS services, as identified by NIHR[3].
This aligns with the Faculty of Pharmaceutical Medicine’s (FPM) commitment to maximising the value of clinical research and ensuring that all scientific efforts serve public health. It also opens the opportunity to understand the true potential of trial drugs in sub populations that might otherwise be obscured by a homogeneous analysis of a population. Expanding studies and their relevance to wider populations while looking at smaller responder groups and safety profiles can open up fascinating insights by ‘going big with precision’ simultaneously. FPM was a key contributor to a report which provided 10 recommendations on inclusivity[4] and will continue to support this important aspect of research.
Building a Clinical Research Landscape That Delivers for All
Underpinning the Guardian article was an analysis authored by MHRA on clinical trial initial submissions received by the MHRA between February 2019 and October 2023[1]. which offers some helpful insights into different types of trial submissions, patient populations and the clinical trial landscape in the United Kingdom. The discussion notes: ”Clinical trials are central to advancing scientific knowledge and can have an impact on many areas, including (but not limited to) new drug development, understanding of disease mechanisms and identification of biomarkers”. There is therefore something here for everyone within FPM.
As we mark World Clinical Trials Day 2025, the UK finds itself at a critical inflection point. With updated regulations and a renewed focus on diversity, we are uniquely positioned to lead the world in ethical, inclusive, and impactful research. And, as pharmaceutical physicians, we have a duty to build a future where this is embedded in our daily activities. Why not start by joining Dr Amy Rogers, an expert in clinical trial methodology from the University of Dundee, in her Journal Club on Thursday 22 May 2025? She will be discussing a paper on participant recruitment, retention and adherence in decentralised clinical trials (DCTs).
So please join FPM in recognising this important day. Let’s ensure that in tomorrow’s clinical research, no trial drug is left behind – and no patient is left out.
References
- www.gov.uk. Clinical Trials regulations signed into law. [online] Available at: https://www.gov.uk/government/news/clinical-trials-regulations-signed-into-law.
- www.hra.nhs.uk. Clinical trial regulations reform. [online] Available at: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/clinical-trial-regulations-reform/.
- www.theguardian.com. ‘Concerning’ lack of female-only medical trials in UK, say health experts. [online] Available at: https://www.theguardian.com/society/2025/may/07/concerning-lack-of-female-only-medical-trials-in-uk-say-health-experts.
- www.eur-lex.eu. Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations. [online] Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202401689
- www.nihr.ac.uk. Research for Patient Benefit. [online] Available at: https://www.nihr.ac.uk/research-funding/funding-programmes/research-for-patient-benefit
- www.doi.org. Analysis of 4616 clinical trial initial submissions received by the Medicines and Healthcare products Regulatory Agency between February 2019 and October 2023. [online] Available at: https://doi.org/10.1002/bcp.70061
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