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Clinical trials are the experimental foundation on which modern medicine is built. Trials also make a significant contribution to the UK economy and can provide patients with an important means of accessing the most exciting and innovative new treatments, before they reach the market.
Unfortunately, in recent years the number of trials taking place in the UK has fallen steeply. This is partly due to the European Clinical Trials Directive (CTD), which since 2001 has posed a significant barrier to those wishing to conduct a trial in the European Union, and the ongoing revision of which we keenly welcome. However, the CTD aside, a unique regulatory and governance landscape means that the UK remains a particularly challenging place in which to conduct a clinical trial.
To date, the Government has failed to eliminate the biggest barrier to initiating a trial in the UK—the requirement for numerous, and potentially duplicate, governance approvals from participating NHS organisations. The newly formed Health Research Authority (HRA) was created to make it easier to conduct research in the NHS, but we have been unable to judge whether it has been successful in achieving this objective as the necessary performance indicators are not currently in place. We were also concerned to find that some important stakeholders are only dimly aware of the HRA and its intended role. In addition, despite positive public attitudes towards medical research, it is difficult for the public to find out about potential research opportunities and Government efforts to rectify this through the re-launch of the UK Clinical Trials Gateway have been only partially successful.
While we are confident that the Government is aware of these problems and the need to resolve them, its promises have yet to be matched by effective action. More can and should be done to make the UK a more attractive location for clinical trials.
Another key focus of our inquiry has been the issue of clinical trial transparency. We consider that information relating to trials should be shared in a way that is accessible, assessable, intelligible and usable, and we have differentiated in our recommendations between four distinct levels of trial transparency:
a) Universal trial registration is crucial to increasing transparency and, in future, all clinical trials conducted in the UK, and all trials related to treatments used by the NHS, should be registered. We extend this recommendation to past trials, and urge the Government to support the retrospective registration of all trials conducted on treatments currently in use by the NHS.
b) It is also important that summary-level trial results are made public, and we do not accept the argument that it is not possible to publish "negative" results in peer-reviewed scientific journals. We recommend that trial registration and publication of summary-level results be made contractual requirements for all publicly-funded trials, including those covered by the Charity Research Support Fund, and urge the Government to conduct a retrospective audit of all large public trial grants awarded since 2000 to ensure that they have been registered and published.
c) It would be unduly burdensome to mandate that full trial reports—clinical study reports (CSRs)—be produced for non-commercial trials. However, in cases where they are already produced for regulatory reasons, CSRs can make a useful contribution to the scientific literature. Once a regulatory decision has been reached, there is no compelling reason why CSRs should not be placed in the public domain, with identifiable patient data redacted.
d) We are not in favour of placing anonymised individual patient-level data (IPD) in the public domain in an unrestricted manner, as the risk to patient confidentiality is too great. Instead, specific individuals should be provided with controlled access to IPD through carefully managed and secure "safe havens". Access should be facilitated by an independent "gatekeeper", responsible for ensuring that data is handled responsibly and in a way that makes a useful contribution to scientific knowledge.
We consider the current lack of trial transparency to be unacceptable and we have not been impressed by the Government's efforts to resolve this problem to date. We ask the Government to enhance its efforts to increase transparency and to consider the recommendations of this Report in preparing its response to the European Medicines Agency's ongoing consultation on access to clinical trial data.
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