An AllTrials report for the House of Commons Science and Technology Select Committee this week has found that 33 NHS trust sponsors and six UK universities are reporting none of their clinical trial results, while others have gone from 0% to 100% following an announcement from the Select Committee in January that universities and NHS trusts with missing trials had 6 months to correct it.
Under UK rules, as in other countries, all clinical trial results must be reported within one year. Unreported trials compromise patient safety, waste resources, abuse the trust of trial participants and result in an inaccurate benchmark for new treatments. This applies regardless of whether the clinical trial was successful or not.
The chair of the Select Committee, Norman Lamb MP and Sense about Science – which runs the global AllTrials campaign – wrote to all trusts and universities in January to urge them to rectify missing trials within 6 months. The AllTrials review found:
- Just over a third of their trials now remain unreported. The combined reporting rates of UK universities and NHS trusts have increased since January, from 48.1% to 63.9%.
- Over the period 2 UK universities and 3 NHS trusts progressed from 0% reporting to 100% reporting. There are now 4 UK universities and 5 NHS trusts showing on the register as having reported 100% of their results.
- There are 33 NHS trusts and six universities that have reported 0% of their due trials.
- Excuses given to the committee and to AllTrials for non-reporting included: boosting chances of publication in a top journal, staff moving on and the mistaken belief that the law was not applicable.
Read the report here. It includes full data set for UK university and NHS trust-sponsored trials. In some cases, we’re down to just one or two unreported trials. Do you work at a UK university or trust, or are a student or alumnus of or a donor to one? Please look for the organisation in appendix 2 of the report and if they have not reported 100% of their trials write to them and ask them what they are doing to ensure they report the remaining missing results. You can also find your institute on the EUTrialsTracker where you can see the names and details of unreported trials.
AllTrials’ six months of monitoring work has uncovered some real problems with the European clinical trial database and with medicines regulators’ processes which mean that some clinical trial sponsors are not able to achieve 100% compliance on the register today.
The committee announced today that they will hold an Evidence Session on the 29 October, calling to Parliament some of the institutions who failed to improve their reporting, as well as clinical trial regulators – the Medicines and Healthcare products Regulatory Agency and the Health Research Authority. See more about that here.
The AllTrials campaign has led to global improvements in clinical trial reporting by pharmaceutical companies. In 2018 the campaign urged the Select Committee to investigate public bodies who were persisting in not reporting. That investigation led to the current review. The reporting information was generated using the online TrialsTracker tools developed by Dr Ben Goldacre and the EBMDataLab in the University of Oxford. Síle Lane from the AllTrials campaign offered advice and practical help to researchers and institutions.
Síle Lane, head of international campaigns and policy at Sense about Science and AllTrials campaign co-founder: “There has been incredible progress since we started AllTrials in 2013 to tackle the problem that half of trials were not being reported – a challenge many people said was impossible. The law is clear. It applies to all and if institutions can’t comply they shouldn’t run the trials in the first place. The full reporting rates that we are now seeing in some give the lie to the excuses of others. But the regulatory bodies running the registers should do more to help institutions correct past omissions.”
Dr Ben Goldacre, head of the EBMDataLab at the University of Oxford and AllTrials campaign co-founder: “Everyone now agrees that all trials must report their results and comply with the law: the new challenge is around delivery. Our tools use all the current data provided by regulators, and by the trialists themselves. We encourage everyone across the UK to use this data and ensure that they are reporting all their trials on time.”
Dr Karla Soares-Weiser, editor in chief at Cochrane, who supported the report: “At Cochrane, we rely on the availability of clinical trial data to produce high-quality and relevant systematic reviews. We welcome this effort among UK-based non-commercial clinical trial sponsors to improve reporting rates – though there is still clearly much more to be done for all sponsors to meet their full ethical obligations and achieve 100% compliance. Given that this issue goes far beyond the UK, we think it’s time for similar coordinated action on clinical trial transparency in other countries. We encourage researchers, healthcare professionals, patients and members of the public to get involved and to hold clinical trial sponsors to account on their reporting rates.”
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Published: 24 October 2019