It is “unacceptable” that many clinical trials remain unregistered and unpublished. Moreover, “we have not been impressed by the Government’s efforts to resolve this problem to date”, a House of Commons committee has concluded.
The current lack of transparency around clinical trials is undermining public trust, slowing the pace of medical progress and potentially putting patients at risk, says the House of Commons Science and Technology Committee in a wider report on the environment for clinical studies in the UK and the European Union.
The report is based on an inquiry launched in December 2012, which addressed issues such as transparency and disclosure of clinical-trial data; barriers to conducting trials in the UK and EU; the European Commission’s proposed revisions to the Clinical Trials Directive; and the role of the UK’s Health Research Authority in relation to clinical trials.
Registered, published
The Committee would like to see all trials conducted on treatments used in the National Health Service prospectively registered and the results published in a scientific journal.
“While the focus should be on implementing this change for future trials, the Government must also do what it can to ensure that historic trials are registered and published, particularly where they have been publicly funded,” added Committee chair Andrew Miller MP.
The Committee also asks for government action to facilitate wider sharing of the raw data generated during clinical trials.
It does not favour the uncontrolled release of “potentially sensitive” patient-level data, even in anonymised form.
However, raw trial data are “currently underutilised and could be of significant scientific value if shared in a responsible and controlled way, with the knowledge and consent of patients”, Miller commented.
Fewer placed
While data transparency was a primary concern of the inquiry, particularly in light of the pressure building from campaign groups such as AllTrials, the Committee also drew attention in its report to the decline in the number of trials placed in the UK.
It found the local market “particularly challenging” in this respect, with the need for multiple governance approvals from participating NHS organisations identified as the biggest barrier to setting up a trial in the UK – although lack of public awareness was also a key factor.
Clinical trials “make a significant contribution to the UK economy and can provide patients with an important means of accessing the most exciting new treatments”, Miller stated.
“Unfortunately, the UK governance landscape means that researchers can struggle to get trials up and running in this country. Recruiting participants can also be a challenge, even though many patients welcome the opportunity to take part in a trial.”
These problems are “not insurmountable” and the Committee is confident that the UK government is aware of the need to resolve them, Miller noted. “But it is now time for the Government to translate its words into effective action.”
Ongoing discussions
The Report calls on the government to take its recommendations into account in the ongoing discussions on revising the European Union’s Clinical Trials Directive and in its response to the European Medicines Agency’s consultation on releasing clinical-trial data, which closes at the end of this month.
Information on clinical trials should be shared “in a way that is accessible, assessable, intelligible and usable”, the report proposes.
Accordingly, the Committee has distinguished in its recommendations between four distinct levels of transparency:
- Universal trial registration. In future, all clinical trials conducted in the UK, and all trials related to treatments used by the National Health Service, should be registered.
This recommendation extends to past trials, with the Committee urging the government to “support the retrospective registration of all trials conducted on treatments currently in use by the NHS”.
- Summary-level trial results should be made public. The Committee does notaccept the argument that it is not possible to publish ‘negative’ study results in peer-reviewed scientific journals.
It recommends 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 urges 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”.
- Clinical study reports (CSRs). It would be “unduly burdensome” to mandate that full CSRs be produced for non-commercial trials, the Committee believes
However, “in cases where they are already produced for regulatory reasons, CSRs can make a useful contribution to the scientific literature”, it adds. 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”.
- Individual patient-level data (IPD). The Committee does not support placing IPD in the public domain “in an unrestricted manner”, even if they are anonymised. The risk to patient confidentiality “is too great”, it believes.
Instead, “specific individuals should be provided with controlled access to IPD through carefully managed and secure ‘safe havens’”, the report suggests. Access to these data should be facilitated by an independent ‘gatekeeper’, tasked with ensuring that data are handled “responsibly and in a way that makes a useful contribution to scientific knowledge”.
