"Sort it out": Pressure grows on universities to report all clinical trial results
British universities have been told to “sort out” their disappointing clinical trial reporting performance by Sam Gyimah, the Minister for Universities, and Dr Patrick Vallance, the Government Chief Scientific Adviser. Below three key take-away points from the session.
During a hearing of the House of Commons Science and Technology Committee, both government representatives told parliamentarians that they expected universities to make the outcomes of every single clinical trial public.
"Sort it out."
- Sam Gyimah, Minister for Universities
A 2017 TranspariMED study documented that UK universities routinely violate European Union and United States transparency rules, and that over 3,000 university-sponsored clinical trials are lacking results on registries. Data to be published soon by the EBM Data Lab led by Dr Ben Goldacre will show that not a single UK university fully complies with a key EU disclosure regulation, with large variations in compliance rates between institutions.
UPDATE: Major US public research funder NIH has annouced that it will audit whether researchers have registered and reported past clinical trials, and refuse to give fresh grant money to those who failed to do so. This sets a useful transparency precedent that the UK government should emulate.
Five years ago, the very same Science and Technology Committee had already demanded that government agencies get serious about clinical trial transparency. Half a decade later, neither the Health Research Authority (trial registration has been mandatory in the UK since 2013) nor the MHRA (results posting is required under EU regulations since 2014) routinely monitor compliance, let alone sanction violators.
When will that change? What is the UK government planning to do to safeguard patient and taxpayer interests?
1 Everyone agrees that universities should report the results of all their clinical trials
BACKGROUND: Non-reporting of clinical trial results harms patients, wastes public research funding, and slows down the discovery of new treatments and cures. Worldwide, $85 billion in medical research funding is wasted every year because the outcomes of research remain unknown. For these reasons, the World Health Organization and Transparency International have called on governments to ensure that the results of all clinical trials are reported.
Martin Whitfield [MP]: What do you feel your responsibility is, as Minister, to encourage the full reporting of trials?
Dr Vallance [Government Chief Scientific Adviser]: I feel quite strongly about this. Taking part in a clinical study is something that inevitably puts you at risk for the benefit of others. Therefore, the data should be made public. I do not think there should be any exceptions. I think that is true for industry and for academia. All of these trials need to be in the public domain.
Mr Gyimah [Minister for Universities]: I would certainly concur with the suggestion that they [universities] should sort it out.
2 The proposed national clinical trial audit system remains on the table
BACKGROUND: Numerous health integrity groups, including TranspariMED , HealthWatch UK and the AllTrials campaign, have called on the British government to set up a national clinical trial audit system. Under this system, the Health Research Authority would revisit each and every trial that received ethics approval in the UK and check whether, at a minimum, it was registered and posted its summary results onto a registry as required by World Health Organization standards.
Chair: And transparency about who is performing and not performing. Ought we not to know which universities are failing to comply with the 2014 [EU] guidance?
Dr Vallance: It ought to be visible.
Mr Gyimah: Absolutely.
Martin Whitfield [MP]: Why is it being left to others to collect this information on trials that have and have not reported? Why isn’t the information provided trial by trial, through the Health Research Authority? Would that not be a better vehicle?
Dr Vallance: I cannot answer as to why that is not happening.
Chair: Would you encourage the HRA to look at this again and, perhaps, consider a more robust role for it in ensuring complete reporting and transparency?
Dr Vallance: There are now systems in place in the EMA that do the same. Those systems work, so they could be applied more broadly. [Comment: This is a misunderstanding. The EMA can only monitor the minority of clinical trials – called ‘CTIMPs’ – that it regulates. The HRA is the only body that has the information required to monitor all clinical trials in the UK.]
Chair: Minister, I have one further point. For the HRA to carry out a full audit of which research trials have not published their results—we know that a substantial number of them have not—there is a financial implication. Has the HRA come to you with a request for funding to enable it to do that? Would you like it to do that, so that we achieve the transparency you have both said you are committed to? [Comment: The HRA has claimed that it would cost £2.4 million to conduct an in-depth audit that woul.d include the detection of 'outcome switching' in journal articles. However, a more limited audit covering trial registration and summary results posting only would be far, far cheaper.]
Mr Gyimah: No, it has not come to me. I asked to write to the Committee precisely because of some of these issues and how we tackle them.
Chair: If you could look at that, I would be very grateful.
3 No end to impunity?
BACKGROUND: Universities with a track record of wasting medical research funds by failing to report trial results not only do not face any sanctions, but continue to receive public money for new clinical trials.
Chair: Does it concern you that, four years on from the 2014 [EU] guidance, there is such variable practice among academic institutions? Industry appears to comply quite well.
Dr Vallance: There is a cost associated with it, which needs to be built into the research system. [Comment: Trials often cost millions to run; the cost of reporting a trial on a registry is less than £2,000.] Just to be clear, a lot of the failures are timeline failures, rather than not making things public. [Comment: TranspariMED has identified several UK university trials that have remained unreported for over a decade now, and will be lost forever unless action is taken soon.] Personally, I think it would be a mistake to put in a very rigid timeline by which everything must be published, but they should all be published and there needs to be some timeline around that. [Comment: ‘No rigid timeline’ means ‘no red line’ means ‘no accountability’. Clinical trial registries enable results to be reported rapidly. Multiple stakeholders, including Britain's NIHR and MRC, have endorsed the World Health Organisation’s 12 month time frame as appropriate and realistic.]
Martin Whitfield [MP]: Given that, interestingly, the data are going to be published in the very near future, what would your message be to institutions with poor compliance rates?
Dr Vallance: Sort it out.
Martin Whitfield: Would it be any stronger than that, or just, “Sort it out”?
Dr Vallance: It is not my accountability to do that. I have given you my position.
Mr Gyimah: You want institutions to comply with best practice of their own accord.
Vicky Ford [MP]: I want to hear from the Minister whether he is backing the campaign to make sure that all trial results become known. The suggestion [by Dr Ben Goldacre] was that, at a minimum, people who routinely do not publish their trial results should find it more challenging to receive public funding for future trials.
Mr Gyimah: As I said, I am very focused on transparency in what is done. In terms of the actual results, I do not see why not. I am happy to write to the Committee to set that out in more detail, so that we reflect all the complexity of that.
TranspariMED encourages the Minister for Universities to include the following in his forthcoming letter:
A commitment to fund an annual national clinical trial audit by the HRA to make visible which universities adhere to ethical, scientific and legal norms, and avoid generating research waste. At a minimum, the audit should cover the three most basic items: trial registration, summary results posting on registries, and best practice publication. (These are also the cheapest items to audit.)
A clear and time-bound commitment to impose sanctions on universities that fail to produce a detailed roadmap to 'sorting out' their backlogs of unreported clinical trials. (Front-running UK universities including Aberdeen and Bristol are already doing this.)
The SciTech Committee’s research integrity enquiry is now closed. Once its final report is published, TranspariMED will publicly monitor whether government agencies adopt its recommendations. Keep tuned to this blog.