February 22, 2019: The Department of Health and Social Care has today responded to the Research Integrity: Clinical Trials Transparency Report, published by the House of Commons Science & Technology Committee in October 2018.
Baroness Blackwood, Parliamentary Under Secretary of State for Health (Lords), noted in the Government report released today that “Only with a system which values transparency can we hope to improve patient care and support the sustainability of the health and care system through research. I therefore agree with the Committee that clinical trials transparency is vital to the integrity of research. The Government welcomes the opportunity to address the issues raised in this report.”
AllTrials’ response to the government report can be read below:
Tracey Brown, director of Sense about Science: “Unpublished trials put patients at risk, mislead doctors and waste the goodwill of the patients who participate as well as millions of pounds. Why should researchers be funded and approved again if they didn’t publish their previous trial? Trial approval bodies such as the Health Research Authority are vital to fixing it. The Select Committee was right to call for the HRA to conduct a nationwide audit of which companies and researchers have not reported their trials. The HRA has said it is willing and the government has agreed there is a case to look at. We are looking forward to its confirmation that HRA is being given the resources to do it. These will be a drop in the ocean of the costs of repeated and pointless trials.”
AllTrials will be monitoring the performance of UK universities and NHS Trusts and will be reporting back to the committee so that it can pull in any bad performers. The EU Clinical Trials Register tracker, developed by EBMDataLab, shows that out of 263 due trials from NHS Trusts just 93, or 35.4 per cent, have submitted results to the EU register, as required by EU guidelines. This is much worse than the compliance rate elsewhere – 59.7 per cent compliance for UK Universities, and 54 per cent for the EU register overall.
The Science and Technology Committee also released a response to the Government report today, declaring that it’s ‘high time this problem is fixed once and for all.’
Rt Hon Norman Lamb MP, Chair of the Science and Technology Committee:“We commend the HRA for itswillingness to rise to the challenges we have set them, and we now need to see the Government back the HRA up with the resources it clearly needs.
“While we welcome the Government’s response, it is disappointing that four months after our Report was released, we still don’t have any confirmation of the additional funding needed to support the Health Research Authority (HRA) to implement our recommendations.
“The Committee remains hopeful that a decision will be made on funding for audits of clinical trials reporting before we return to this issue after the summer.
“In the meantime, the HRA’s commitment to produce a strategy to drive improvements in trial reporting and registration is a crucial first step. The HRA have clearly listened to our recommendations, and we look forward to seeing them take shape.
“The HRA response confirms that it has written to all NHS Trusts with unreported trial results to ask them to them to tackle this problem. I will also write to them in due course to highlight our intention to hold an evidence session on this topic after the summer, to match the message we’ve already sent to universities. If things haven’t improved by then we’ll want to bring them before the Committee to find out why and to hold them to account.
“It’s high time this problem is fixed once and for all, and we will build on this drive from the HRA.”