The United Kingdom is calling for greater clinical trial transparency after a government committee released a report that indicates that data from about half of all clinical trials in that country are not published, raising concerns over research integrity and risks to human health.
The United Kingdom is calling for greater clinical trial transparency after a government committee released a report that indicates that data from about half of all clinical trials in that country are not published, raising concerns over research integrity and risks to human health.
The report, “Research integrity: clinical trials transparency,” was released by Parliament’s Science and Technology Committee. The report decries the failure of researchers to disclose trial results regardless of the outcome. The report notes that a lack of published data is not only a “threat to research integrity,” but also increases risks to individuals.
“In the case of clinical trials, non-publication of results means that information on the efficacy of new drugs or other medical interventions cannot be used. Falling short on ‘clinical trials transparency’ in this way presents risks to human health, contributes to research wastage and means that clinical decisions are made without access to all the available evidence,” according to the report summary.
The report does not particularly single out any pharma company for a failure to disclose but did point a finger at trials conducted by universities and publicly funded organizations such as Public Health England for a failure to disclose.
The U.K. study was initiated as a follow-up to a similar investigation launched five years ago by the preceding science and technology committee. In 2013, that committee concluded that the government’s efforts to resolve the same issue of the lack of published data for clinical trials was unimpressive. The committee said that over the past five years there have been some improvements in clinical trial reporting, but “there is still much to be done.” The committee said the Ebola epidemic initially prompted government interest in clinical trial transparency, with former Prime Minister David Cameron making commitments to clinical trials transparency in 2015. Since then, the committee said progress has “slowed in the U.K. at a political level.”
In the United Kingdom, the Health Research Authority (HRA) is responsible for research transparency – something with which it was charged in 2014. However, the committee said that has not brought about significant change.
“The government should ask the HRA to publish, by December 2019, a detailed strategy for achieving full clinical trials transparency, with a clear deadline and milestones for achieving this. The performance of the HRA should then be explicitly measured on this basis through its annual report,” the committee said in its report summary.
The committee further added that the HRA should receive funding to create a national clinical trials transparency auditing program. That program would include the publication of an official list of which U.K.-based trials have published results and which do not.
Clinical trial transparency is a serious issue and has been for some time. In a 2016 interview, Thomas Wicks, TrialScope’s chief strategy officer, told BioSpace that one of the key reasons for clinical transparency is the need to “promote the idea that if a trial has already been run by one company, then a similar trial won’t necessarily be run again by a different company evaluating the same criteria.”
Bioethics International maintains a “Good Pharma Scorecard” that tracks clinical trial transparency. Johnson & Johnson has held onto the top spot as the most transparent company two years in a row, according to the scorecard.
