The letters have been written following the Committee’s recent Report on clinical trials transparency, which highlighted that many universities appear to have a poor track record in this area.
Falling short on ‘clinical trials transparency’
The Committee noted in the Report that falling short on ‘clinical trials transparency’ through failing to publish clinical trials results “presents risks to human health, contributes to research wastage and means that clinical decisions are made without access to all the available evidence”.
These institutions have been asked to verify that systems are being put in place to ensure that they adhere to current transparency rules and legislation going forward. Most of the institutions the Chair has written to have overdue trials. Others will have trials that will be due soon.
The Committee intends to revisit this issue later this year and may choose to question institutions that have not improved their compliance by that point.
Rt Hon Norman Lamb MP, Chair of the Science and Technology Committee, said:
“The Committee applauds the universities that have reacted quickly to the clinical trials transparency problems we identified in October.
“However, it’s deeply disappointing that on the face of it most have failed to respond to the challenge so far. Universities and other trial leaders need to act on this as a matter of urgency.
“Our Committee will be returning to this issue with a follow-up evidence session, so I’m putting all universities on notice that they will be asked to come before us to explain themselves if they haven’t got their house in order by then.”
See sample letter text below:
In October 2018, the Science and Technology Committee’s Report on clinical trials transparency highlighted that the results of clinical trials are not being reported in many cases, and that a number of universities appear to have a poor track record in complying with transparency rules and legislation in this area.
I am writing to ask you to verify that systems are being put in place at your institution to ensure that you comply fully with clinical trials transparency requirements. I would also like to alert you to the fact that the Committee intends to revisit this issue after the summer recess, and may wish to question institutions that have not improved their compliance by that point. Similarly, we may also be interested in hearing from those universities who have made significant progress in correcting this problem so that they can share good practice in this area with others.
There are two specific sets of rules that I would like to draw your attention to:
- Since July 2014, the European Commission has required all trials on the EU Clinical Trials Register (i.e. trials of medicinal products) to post results to the registry within 12 months of completion, with a final compliance date of 21 December 2016.
- US law in force since January 2018 (the FDA Amendments Act 2007, FDAAA) requires results of certain trials registered on clinicaltrials.gov (i.e. a much wider set of clinical trials, including medical devices) to report results on the same timescale.
Recent work by Dr Ben Goldacre and colleagues at the EBMDataLab (part of the AllTrials campaign) provides a means of tracking each institution’s compliance with these requirements. The data from the EU Trials Tracker website relating to your institution (as of January 2019) are as follows:
- Number of trials listed on EU Clinical Trials Register (EUCTR) with [Name of institution] as the sponsor or co-sponsor: XXX
- Number of trials listed on EU Clinical Trials Register as being complete: XXX
- Number of which have reported results: XXX
Details of your EUCTR compliance are available from [URL]
The Committee will contact you over the summer if the data at that point suggest that there is a concern about compliance with reporting requirements.
In the meantime, the AllTrials Campaign (www.alltrials.net) would be pleased to advise you on the steps needed to make progress in this area over the coming months.
- Aston University
- Bangor University
- Cardiff University
- City, University of London
- Imperial College London
- Keele University
- King's College London
- London School of Hygiene and Tropical Medicine
- Newcastle University
- Oxford Brookes University
- Queen Mary University of London
- Queen's University Belfast
- St George's, University of London
- Swansea University
- University College London
- University of Aberdeen
- University of Birmingham
- University of Brighton
- University of Bristol
- University of Cambridge
- University of Dundee
- University of East Anglia
- University of Edinburgh
- University of Exeter
- University of Glasgow
- University of Hertfordshire
- University of Hull
- University of Leeds
- University of Leicester
- University of Liverpool
- University of Manchester
- University of Nottingham
- University of Oxford
- University of Portsmouth
- University of Sheffield
- University of Southampton
- University of Surrey
- University of Warwick
- University of York
- University of Plymouth
- University of Wales
Find out more about individual trials here.