In the European Union (EU), guidelines require all trials of medicinal products registered on the EU Clinical Trials Registry (EUCTR) since 2004 to report results within one year of completion.
The House of Commons Science and Technology Select Committee in October 2018 published a report stating that “failing to publish data from clinical trials presents risk to human health.” The report, ‘Research Integrity: Clinical Trials Transparency,’ also called on the UK Government to ensure all UK trials have reported results.
Additionally, the report identified issues with UK universities, said Síle Lane, head of international campaigns and policy at Sense about Science and AllTrials campaign co-founder. “As a result, the Committee decided it must follow up its report and urge universities to act,” she told us.
Now, the Chair of the Science and Technology Select Committee, Norman Lamb MP, has written to more than forty UK universities. The committee also today has announced that UK universities could be brought in front of the Committee if they fail to improve clinical trial reporting.
“The Committee applauds the universities that have reacted quickly to the clinical trials transparency problems we identified in October,” Lamb said in the press release.
“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.”
AllTrials – a global campaign coordinated by Sense about Science and the EBMDataLab calling for all clinical trials to be reported – supplied the Committee with a list of UK universities that are currently running and responsible for clinical trials.
Moving forward, AllTrails will monitor the universities’ progress using its online TrialsTracker tool, which keeps tabs on those trials which have reported results and those which who have not. In six months, AllTrials will then advise the Committee on which universities’ have made progress.
“The support from the UK parliament will mean that UK universities, and their chancellors, will have to sit up and take notice,” said Lane.
Tracking change through a global campaign
In the US, the US Food and Drug Administration (FDA) Amendments Act (FDAAA 2007) requires certain clinical trials to report results to ClinicalTrials.gov within one year of completion, and the agency can impose a fine of $10,000 a day for every overdue or unreported trial.
According to AllTrials:
- 46% of EU trials have not reported results according to the EU’s reporting rules
- Companies are more likely to follow reporting obligations than universities
- Only 44% of the world’s largest charity and government bodies require researchers to report clinical trial results
- In the US, only 62% of trials have been reported
“However, the reality is that enforcement action has never taken place, so there has not been anything pushing organizations to publish their clinical trial results,” Lane said. “Previously, there have been barriers to publishing results and the issues surrounding it had not been on the public agenda.”
In 2019, Lane said this is no longer the case in the US or the EU, where reporting results is now more straightforward. She also noted that the AllTrials campaign “has put the issues surrounding missing trial results firmly on the agenda of companies, researchers and parliamentarians across the globe.”
More than 90,000 people and 750 organizations globally have joined the AllTrials campaign, including contract research organizations (CROs), consumer groups, medical organizations, universities, pharmaceutical companies, as well as patient support groups representing nearly 600m patients.
“The AllTrials campaign is a global movement and we’ve already convinced hundreds of major organizations to join the campaign, and we hope more universities will now be urged into action,” said Lane.
“The issues surrounding clinical trial reporting had not really been on the public or political agenda until the AllTrials campaign started calling for urgent action to be taken," she added. "The awareness raised helped put the issues firmly in the public eye.”