Fiona Maini, principal, global compliance and strategy at Medidata comments on the recommendations of the O’Shaughnessy report, explaining how this could impact the UK landscape for clinical trials.
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Clinical trial
The UK Government recently published the Lord O’Shaughnessy review into commercial clinical trials. The report highlighted the UK’s strong track record in clinical research, but noted that over recent years, the country has fallen behind some international peers both in terms of the number of trials being conducted and the number of patients being enrolled into these trials. Challenges caused by the UK leaving the EU, a lack of awareness amongst patients about clinical trials, and a relatively slow adoption of the use of new technology in the design and conduct of clinical trials have been facets that have contributed to this downturn. Through embracing innovation and supporting the clinical trial network and ecosystem in having the capacity to conduct clinical trials, we can ensure that the UK remains an internationally competitive hub for clinical research.
The report highlighted that the number of commercial-led clinical trials conducted in the UK dropped by 44% between 2017/18 and 2021/22, which undoubtedly is at least partially because of Brexit. Since leaving the EU, the UK has become a much less attractive and a more costly place to conduct clinical trials. When we were part of the EU, there was a single regulatory regime across all member states, whereas now, companies wishing to run multi-country trials in Britain and the EU have to navigate two different systems. In addition, the MHRA lost a large proportion of its revenue when we left the EU and has lost further resources during the transition process due to cost-cutting and reorganisation. As a result, it is now under-resourced and needs to ramp its capacity back up and address the skills gap in its workforce to speed up the clinical trials approval process to keep up with demand. Currently, clinical trial approval times are higher in the UK than several other countries, which makes the UK a less attractive place to conduct trials.
The report also emphasises the need to increase recruitment on clinical trials. Currently, most patients are unaware of clinical trials that are ongoing or know that they could be eligible to participate in a trial. The report’s proposal to enable GPs to be more involved in clinical research seems like a positive step, as GPs can help to make people aware of relevant trials that are running. In addition, the UK needs to get better at leveraging technology to help with patient enrolment. AI can sift through huge amounts of data to identify patients who could be eligible to participate in a trial, and sites that have been successful in recruiting a specific patient population in the past. For example, at Medidata we have an Intelligent Trials tool which allows companies to analyse historic performance metrics from previous trials to develop predictive enrolment models and provide live tracking of sites. This type of solution allows companies to increase their enrolment at a faster rate, and provides insights on how to improve the diversity of trials to ensure that they are as representative of the population as possible. The UK has significant amounts of data available from the NHS, and now is the time to harness its potential to accelerate clinical research.
Another area that the report identifies as crucial to ensuring that the UK remains a good place to conduct clinical trials is embracing new technologies to enable more accelerated trials. The MHRA has already started looking at its processes and providing guidelines on the use of technology in trials, and it has always shown a willingness to adapt to new technologies. It is important that the regulator continues to give the industry confidence in using more modern systems and digital technologies and remains in dialogue with the industry about what guidelines need to be put in place. It would be good to see the MHRA develop some guidance around decentralised clinical trials (DCTs), like those released by other regulators such as the US Food and Drug Administration (FDA). This would help to walk the industry through the various DCT processes to develop an understanding of what DCTs are and the use case for them. Going back to AI, the MHRA has already produced an AI change program and are working with the FDA and Health Canada to establish principles around the use of AI in healthcare, but there is potential to tailor this to clinical trials specifically so that the industry has clear guidance and principles to adhere to. In both of these cases, there’s no need to reinvent the wheel, but rather to look at what other countries are doing and the work that has been done in the UK to date to ensure we have a clear framework.
In terms of actioning the report, it will be vital for the government and industry to first establish agreement and consensus around its recommendations and the desire to change the UK clinical trials environment. Given that the report has nearly 30 recommendations, it will then be important to prioritise those which should be implemented as soon as possible and develop an action plan with timelines and KPIs to ensure that these are actioned. One surprising element of the report was the lack of transparency that can exist around who is running trials and which elements they are responsible for, so it will be important going forward to ensure that there are clearly defined roles and responsibilities for each process. It will also be key to look at all the different stakeholders in the UK clinical trials ecosystem and think what needs to be done for each of them to enable more research to be undertaken and more patients to be enrolled on clinical trials.
Overall, the report is very positive about the potential for the UK to become a leader in attracting commercial clinical trials, if the government and industry can act on these recommendations. There has been a lot of rhetoric over the past few years about making the UK a leader in life sciences and a hub for innovation, and it is now time to turbocharge these efforts and incentivise companies to come to the UK to conduct their clinical research.
