Celebrating Clinical Trials Day on 20 May
Posted on: Monday 20 May 2024
Author: Dr Kirsty Wydenbach MFPM et al
George Bernard Shaw’s play ‘The Doctor’s Dilemma’ was first staged in 1906 in London and includes the following passage in the preface to the play:
“Attention and activity lead to mistakes as well as to successes; but a life spent making mistakes is not only more honourable but more useful than a life spent doing nothing. The one lesson that comes out of all our theorizing and experimenting is that there is only one really scientific progressive method and that is the method of trial and error.”
Whilst he was referring to a general laissez-faire attitude being less than ideal for society, he could well have been discussing modern day clinical trials. Lots has changed in medicine since Bernard Shaw wrote his play, but reflecting on Clinical Trials Day on Monday 20 May 2024, what can we envision for the future?
“The government has announced plans to make the UK a global hub for life sciences, with a focus on innovation, collaboration, and patient-centred research.”
I feel we have been saying for several years that the future of UK clinical trials is promising, with the government investing in research and development, and initiatives to streamline the process of conducting clinical trials. Although the UK has a strong track record in clinical research, with world-class universities, research institutions, and a thriving life sciences industry, which has driven success in early phase and translational studies, it has not consistently been translated into Phase 2 and 3 clinical trial performance. This has been true for start-up times as well as recruitment to target. Previous reports [1][2] have however shown the extent of the potential for the UK. The ability to recruit large numbers of subjects across multiple sites in a short time period, demonstrates how a largely unitary healthcare system can perform when it is aligned. Importantly, many of these studies involved more real-world use than is typical in the classical controlled clinical trial and reflect clinical reality and the patient experience to a much greater extent. This too demonstrates the vast potential for the usability and relevance of UK study data which is not necessarily possible in other countries’ health systems.
The government has announced plans to make the UK a global hub for life sciences, with a focus on innovation, collaboration, and patient-centred research. This includes important initiatives to attract investment, support small and medium-sized enterprises, and improve the regulatory environment for clinical trials, together with a commitment to working with international partners to advance global health and medical research. These promote the widening of the UK’s share of global clinical trials, in both participation and design, to ensure the data has wider applicability for the assessment of effectiveness as well as safety and efficacy.
There is much to look forward to. The UK clinical trials legislation is under revision and recent metrics [3] indicate the huge efforts taken by MHRA to get timelines back on target for clinical trial approvals. The EU transition period for clinical trials will come to an end on 30 January 2025, with many learnings for Sponsors and further improvements and fixes regularly planned [4]. Transparency for trial data has already changed, not just with the legislative requirements, but with revised rules applicable from 18 June 2024 [5] which aim to simplify what was a complex requirement. To return to Bernard Shaw, this should also help with learning through trial and error by understanding what others have done.
Artificial intelligence (AI) is playing an ever-larger role in everyday life, and clinical trials is not spared. Where will we be by the next Clinical Trials Day? With use of AI for accelerating participant recruitment, predicting trial outcomes, reducing study numbers, and with greater adoption of wearables and opportunities for improving efficiencies through other digital health technologies and decentralised trial design, we can only begin to imagine how the landscape will change. There is also growing discussion on diversity in clinical trials [6], and a welcome focus on including patients throughout the design of a trial, throughout its conduct and beyond. These elements will only improve and expand as the pharmaceutical industry and associated bodies, including FPM, embrace integration of these improvements into research.
But 20 May is not just about clinical trials: for those who have interests outside of clinical trials, it is also World Bee Day and National Quiche Lorraine day! So here’s hoping that Bernard Shaw remains relevant in the next 100 years of clinical trials and that the sun shines for all the bees and picnic-ers out there.
References
- www.abpi.org.uk. Global rankings – Number of industry clinical trials initiated in 2021, by country, by phase. [online] Available at: https://www.abpi.org.uk/facts-figures-and-industry-data/clinical-trials/global-data/global-rankings-number-of-industry-clinical-trials-initiated-in-2021-by-country-by-phase/.
- www.abpi.org.uk. Getting back on track: Restoring the UK’s global position in industry clinical trials. [online] Available at: https://www.abpi.org.uk/publications/getting-back-on-track-restoring-the-uk-s-global-position-in-industry-clinical-trials/.
- GOV.UK. MHRA performance data for assessment of clinical trials and established medicines. [online] Available at: https://www.gov.uk/government/publications/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines.
- euclinicaltrials.eu. Website outages and system releases – EMA. [online] Available at: https://euclinicaltrials.eu/website-outages-and-system-releases/.
- accelerating-clinical-trials.europa.eu. Launch of revised CTIS transparency rules – European Union. [online] Available at: https://accelerating-clinical-trials.europa.eu/newsroom/news/launch-revised-ctis-transparency-rules-2024-04-22_en#:~:text=The%20revised%20transparency%20rules%20for.
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Health Research Authority. Increasing the diversity of people taking part in research. [online] Available at: https://www.hra.nhs.uk/planning-and-improving-research/best-practice/increasing-diversity-people-taking-part-research/#:~:text=The%20Health%20Research%20Authority%20(HRA.
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