1.In July 2018 we published our Report on research integrity, exploring a range of threats to the rigour, accuracy, honesty and transparency of research. These included ‘fraud, fabrication and plagiarism’ and a range of ‘questionable research practices’, any of which can lead to unreliable research being published. However, during that inquiry we were told that selective non-publication of research results—or ‘publication bias’—was also a threat to the integrity of the evidence base and should be considered as part of our work. Indeed, the Concordat to Support Research Integrity produced by Universities UK and signed by the higher education funding councils and research councils states that “refusing to publish negative research findings” is “harmful to the reputation and quality of UK research, and to the research record”.
2.Further exploration of the issue of publication bias during our inquiry into research integrity revealed an opportunity for us to follow up on work by our predecessor Committee from 2013 on clinical trials. One of the issues our predecessor explored was the extent to which the results of clinical trials of drugs, vaccines and other health interventions are made available to scientists, clinicians and members of the public—often referred to as ‘clinical trials transparency’. Our predecessor Committee noted “long-standing concerns” that the results of many trials “currently remain hidden from public view”, which, according to campaigners, “undermines public trust, breaks the ethical pact between scientists and those participating in trials and leads to clinical decisions being made on the basis of incomplete evidence, potentially leading to poorer outcomes for patients”. They concluded that:
many of the clinical trials taking place in the UK remain unregistered and unpublished and their data continue to be unavailable to both the general public and the scientific community. This is unacceptable and we have not been impressed by the Government’s efforts to resolve this important issue.
3.Underlining the need to explore clinical trials transparency as part of our work on research integrity, Dr Ben Goldacre, a medical doctor and Director of the Evidence-Based Medicine DataLab at the University of Oxford, argued that, five years on from that Report, clinical trials transparency remains a significant issue, with non-publication of results distorting the evidence base on which important decisions are made:
[Academic] fraud is not the most important issue. The culture of incomplete and inaccurate reporting of research has greater impact on patients and society […] [Clinical] Trials are large expensive research projects used to generate knowledge that is then used, in clinical practice, to make vitally important decisions; and yet trials are commonly left unreported, or misreported. This is a waste of money, and distorts the evidence underpinning medical practice.
4.We were told that “around half” of clinical trials currently go unreported (see Chapter 2), and that results from clinical trials with positive results were twice as likely to be published as others. We were also provided with some explicit examples of non-publication of clinical trials results leading to wasted public expenditure in the UK and even patient deaths in other countries. Two examples are set out below:
5.On this basis, we took oral evidence from Dr Goldacre, Dr Kolstoe and the AllTrials Campaign as part of our research integrity inquiry. We also took evidence from the Health Research Authority to explore solutions to the non-publication of clinical trials results. Given the significance of this topic as a public health issue, we agreed to produce this separate short Report on clinical trials transparency, drawing on the evidence we received during our work on research integrity and providing an update on our predecessor’s 2013 Report. We are grateful to everyone who contributed to this aspect of our work.
2 Work on research integrity began during the 2015 Parliament, under the previous Committee. Written evidence received by that Committee (i.e. prior to the 2017 General Election) is labelled with ‘RIN’ prefixes; evidence received by the current Committee is labelled with ‘RES’ prefixes. All oral evidence for the inquiry took place during the 2017 Parliament. For further details see link in footnote 1.
8 Dr Ben Goldacre () para 0
9 AllTrials campaign ()
10 Dr Simon Kolstoe () para s3
11 Public Accounts Committee, Thirty-Fifth Report of Session 2013–14, Access to clinical trial information and the stockpiling of Tamiflu, HC 295
12 AllTrials campaign ()
Published: 30 October 2018