Sponsors ‘still have further to go’ as 50% of trials go unreported: Report
The UK House of Commons Science and Technology Committee recently released a report addressing the current state of clinical trials transparency.
According to the report, “the selective non-publication of the results of research distorts the published evidence base and is a threat to research integrity.”
While new rules and guidelines in the UK and EU have aimed to address this issue, the committee reported that around half of clinical trials are currently left unreported. Additionally, clinical trial registration is not universal in the UK, and reported outcomes do not always align with the original study proposal, it said.
The Health Research Authority (HRA) has been responsible for promoting research transparency as part of its statutory objectives since 2014, “but this does not appear to have brought about significant change in this area over the last four years,” according to the report.
As such, the committee is calling on the Government to ask the HRA to publish a detailed strategy for achieving full clinical trials transparency, with a clear deadline and milestones by December 2019.
“Clinical trials transparency is as much a question of political will as it is a technical issue,” the report said.
The committee also said the HRA should be provided with funding to establish a national program to audit clinical trials transparency. It also said HRA should introduce a system of sanctions “to drive improvements in clinical trials transparency, such as withdrawing favorable ethical opinion or preventing further trials from taking place.”
“The Government should consult specifically on whether to provide the HRA with the statutory power to fine sponsors for non-compliance,” the report explained.
Public Health England and various NHS Foundation Trusts also are failing to report results from clinical trials, which the committee said is “particularly disappointing.”
“Public trust in medicine could easily be eroded by failures in clinical trials transparency from such important parts of the health system,” it explained, calling on Public Health England to explain the steps it will take to correct this.
The big questions: Will the government listen?
Till Bruckner, PhD, founder of TranspariMED, and advocacy manager at Transparify, said the first the first big question is whether the government will listen – “it didn't last time.”
In 2013, the committee published a report on clinical trials calling the lack of trial transparency “unacceptable.”
“We have not been impressed by the Government’s efforts to resolve this problem to date,” the report read. Five years later and the new committee said there is “still much more to be done.”
Bruckner told us he is optimistic, as the committee has made a strong case, the HRA has responded positively, and many are watching this closely.
The second big question is whether the HRA will conduct only “light” audits or also check for outcome switching within journal publications, as recommended by the committee, he explained.
Though Bruckner said the cost would probably be far cheaper in practice, HRA estimates the price tag of a full audit at £2.4m ($3.06m) per yer – “a small price to pay compared with the sums of money involved in policy decisions that draw on clinical trials evidence,” committee said.
The report also highlights “just how far the United States has fallen behind in terms of clinical trial transparency,” Bruckner noted.
“It's pretty certain that the UK will start imposing fines in the foreseeable future, and Germany seems to be heading in the same direction.
Meanwhile, the FDA is still refusing to even notify companies when they are breaking disclosure laws, while $939m in fines owed by law-breaking pharmaceutical companies and universities remain uncollected,” he explained.
HRA responds: ‘We are committed to enhancing our work’
The HRA responded with a statement in which it said it welcomes the report.
“We agree with the committee that clinical trials transparency is a vital component for trustworthy science, and essential if we are to ‘protect and promote the interests of patients and the public.’ We are committed to enhancing our work in this area,” the HRA said.
According to the agency, it has already begun taking action on some of the areas raised in the report.
However, a 2016 audit of clinical trials registration showed that while compliance rates are improving, researchers and sponsors “still have further to go,” it said.
The audit also showed that engaging with the research community increases the registration rate. Subsequently, HRA conducted a survey to further explore the issue. Details will be published next month.
“To truly drive innovation and reduce research waste, the HRA will now look how we could take a more robust approach, including potential sanctions, for example not providing ethical approval to new studies until existing ones have been registered in line with the current guidance,” the HRA said.
“Transparency is essential so that participants are protected from unnecessary research and patients benefit from improved outcomes and care informed by high quality studies,” it continued. “We will act on the recommendations published by the select committee today, and report on our progress.”