Half of Clinical Trials Fail to Publish Results, UK Report Finds

Regulatory NewsRegulatory News | 30 October 2018 |  By 

Despite UK and EU rules aimed at boosting clinical trials reporting and transparency, a new report by the UK House of Commons’ Science and Technology Committee finds that nearly half of clinical trials fail to publish results.
“Around half of clinical trials are currently left unreported, clinical trial registration is not yet universal in the UK and reported outcomes do not always align with the original study proposal,” the report finds.
Based on these findings, Member of Parliament and Committee Chair Norman Lamb said that “an astounding amount of information from clinical trials is going unreported. The [Health Research Authority] HRA must act now to ensure current regulations are enforced and impose tough sanctions on those who seem to think it is acceptable to disregard valuable research, threaten research integrity and, in some cases, endanger human life.”
Lamb also expressed disappointment that many of the entities that have failed to report clinical trial results are publicly funded institutions.
“The tax payer has a right to expect those who benefit from public funding to follow the rules and publish in full,” he said.
The report also puts some of the onus for improving clinical trial reporting on the government, stating that “progress has slowed in the UK at a political level. Clinical trials transparency is as much a question of political will as it is a technical issue.”
According to the report, compliance with clinical trials transparency rules varies by the type of sponsor. While drugmakers are largely in compliance with reporting rules, compliance by universities and publicly funded entities such as Public Health England and NHS Foundation Trusts is more mixed.
“Trials with a commercial sponsor were substantially more likely to post results than those with a non-commercial sponsor (68.1% vs 11.0%),” the report states.
Based on their findings, the committee is recommending that the government call on the HRA to come up with “a detailed strategy for achieving full clinical trials transparency” by December 2019 and to provide funding for the HRA to audit UK clinical trials for transparency.
The committee also recommends that the HRA should develop a system for sanctioning those that fail to comply with clinical trials transparency rules, as the report found that “there are currently no sanctions imposed on sponsors or investigators who fail to comply with HRA rules.”
According to the report, the HRA has indicated it would be difficult to secure funding for a more comprehensive approach to auditing clinical trials.
“Even if the cost of fully assessing reported trial outcomes against the original specification in the application for ethical approval amounts to £2.4 million per year, as the HRA suggested in evidence to us, this is a small price to pay compared with the sums of money involved in policy decisions that draw on clinical trials as evidence,” the report states.
Parliament.uk, Report


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy