The government recently commissioned Lord James O’Shaughnessy to lead an independent review on commercial clinical trials in the UK. The report was published on 25th May 2023 and was followed by an announcement £121m of funding to support bringing it to life as part of the “‘Life Sci for Growth’ package”. Nicola Hamilton, Head of Understanding Patient Data (UPD), reflects on what this means from a patient data perspective.
Recommendations relating to patients and patient data include:
- Recommendation 5: The Medicines and Healthcare products Regulatory Agency, the Health Research Authority, the National Institute for Health Research its equivalent organisations across the UK should collect, consolidate and publish national monthly returns on all the clinical trials activity that is happening in the NHS, and NHS bodies and commercial sponsors should publish numbers of patients in trials on a monthly basis.
- Recommendation 6: Building on near real-time activity and performance generated according to the above recommendation, UK governments should create a UK phase 1 to 4 clinical trial directory – called ‘clinicaltrials.gov.uk’ – to create a single source of activity for patients, clinicians, researchers and potential trial sponsors
- Recommendation 14: An ongoing public campaign should be conducted to promote research and to generate evidence on the most effective communication methods, in partnership with medical and research charities.
- Recommendation 15: Full integration of NIHR Be Part of Research with the NHS App should be accelerated, with enhanced opportunities to take part in clinical trials added to the platform.
- Recommendation 18: Agencies responsible for information governance within clinical trials should establish a common approach to contacting patients to take part in research within the current legislative framework
- Recommendation 20: A national participatory process should take place on patient consent to examine how to achieve greater data usage for research in a way that commands public trust. This should seek to establish a publicly supported position around the proactive contacting of patients to take part in trials that could form part of their care
- Recommendation 21: The NHS England Data for R&D Programme’s NHS Research Secure Data Environment Network should be rolled out, including urgent publication of guidance for NHS bodies on engaging in research with industry.
UPD welcomes this report as clinical trials are crucial for getting new and improved treatments and medicines to people who need them, as well as identifying those that may not be efficacious or safe. Using patient data is an essential part of this process, from identifying who might be eligible for a trial, to monitoring adverse effects and other safety concerns, analysing the results, and reporting the results. It may be used to produce aggregated statistics about geographical variation in disease prevalence, which could help identify the best location for a new clinical trial. ‘Code-lists’ could be produced, which clinicians can use to identify all potentially eligible trial participants in their systems. There are various techniques that can be used to reduce the impacts on patient privacy during these of data access and use, and these techniques can be adapted depending on a range of factors, including the sensitivity of the data and level of risk. This is why working within secure data environments is an important step forward, and is already starting to happen.
Whilst the purpose and mechanism of data access might vary, one thing should remain consistent: respect for a patient’s consent – including their consent to share data with research partners that might be outside the NHS. UPD agrees that, currently, this data sharing is done in inconsistent ways, perhaps because of technical, educational, or personal factors. This can hinder research.
We agree there should be conversations with the pubic on data use for clinical trials, particularly on whether the public feel comfortable with the proactive contacting of patients to take part in clinical trials and studies that could form part of their care. The review mentions that individuals who do not want to be approached should be given the opportunity to opt out. This could be a way to respect those patients’ choices, although UPD would want to see more detail on how a proposed opt out would work, noting that managing opt in/out systems can be complex. There are pros and cons to this approach: patients may want to be told proactively about research opportunities in case it can help them and/or others with a particular condition, but they may have also decided that this isn’t a route they would like to take and therefore do not want to receive these communications. This is why more conversations at a local, regional and national level are needed to understand these perspectives, and support should not be assumed given recent concerns that have been raised, for example with the General Practice Data for Planning and Research programme.
If large datasets are to be used more to support patient recruitment to clinical trials, they need to be representative of the entire population. The report notes that both the Clinical Practice Research Datalink (CPRD) and NHS DigiTrials service are limited in scope and this is a problem, because it can mean that some patients’ data is missing or the data being used is not up to date, which can cause further issues and impact health inequalities. By ensuring datasets are more complete, we have an opportunity to increase the representativeness of clinical trials, for example by identifying individuals who might not otherwise be aware of research options.
Finally, UPD believes all results of trials should be published, regardless of whether these outcomes are positive or negative. Therefore, we support the idea of a clinical trials directory. More data in the public domain about clinical trials and their use of patient data is essential to improve transparency and build trust.