Amid a wave of research into potential Covid-19 therapies, a new analysis warns that some trials are being run by universities and companies in Europe that either have no track record filing any trial results with a European database or have failed to do so in the past. As a result, there is a risk that past performance might undermine the ongoing search for safe and effective treatments, according to the advocacy group that conducted the analysis.
Specifically, two-thirds of the 118 Covid-19 trials analyzed are currently run by universities and companies that have no record of uploading clinical study results to the European Union Drug Regulating Authorities Clinical Trials Database, or EudraCT, which trial sponsors are required to do so under EU rules. Of these, 39 trials are being run by sponsors that, in the past, violated requirements to upload results.
Of the remaining 39 Covid-19 drug trials, only eight are run by sponsors fully compliant with EU clinical trial rules, according to TranspariMED, a nonprofit research advocacy group that agitates for greater clinical trial transparency and ran the analysis. Another 40 trials are being run by sponsors unfamiliar with the reporting process because they have not completed any applicable drug trials to date.
Consequently, the advocacy group argued that some research funding, including public money, might yield “research waste,” or results that never see the light of day but could otherwise inform researchers and physicians. “Those investments will only benefit patients if research findings are made public,” said Till Bruckner, who heads the group.
He further noted that more than 4,000 completed drug trials are currently missing results on the EudraCT registry, where sponsors are expected to post their findings within one year after completing the work. More0ver, Bruckner maintained that universities and smaller companies, in particular, tend to have low compliance rates.
The analysis emerges amid ongoing controversy over incomplete clinical trial reporting, an issue that has embroiled drug makers, universities, and policy makers in the U.S. and Europe. The issue has been a flash point following several scandals over safety or effectiveness data that were not publicly shared, prompting a greater push for transparency.
Researchers maintain that without access to specific data, trial results cannot be easily duplicated, which inhibits greater understanding of how medicines might work. And they argue this, in turn, can adversely affect treatment decisions and health care costs, an issue that takes on even greater urgency amid the Covid-19 pandemic and the rush to conduct studies on drugs, old and new.
Of course, it is difficult to extrapolate past performance in order to predict the extent to which Covid-19 trial results may or may not be reported. But TransapriMED noted that national regulators in 14 European countries are responsible for overseeing Covid-19 drug trials and argued for greater oversight. And one regulator agreed with its approach to highlighting concerns.
“From a regulatory point of view, we care about those who turn out not be compliant, not those who may not be compliant,” Thomas Senderovitz, director general of the Danish Medicines Agency, told us. “But it’s fair to raise a flag and remind everyone they should make clinical trial data public according to legislation. We take it very seriously that sponsors are very meticulous in filing their results.”
Indeed, earlier this year, the Danish Medicines Agency threatened to pursue sanctions — including fines and prison sentences —against drug companies and universities that fail to publish their study results in the EduraCT database, as required. Senderovitz said the agency has so far issued one reminder, but has not yet issued any fines.
One researcher who has clinical transparency concerns maintained that alerting the public to previous transgressions puts sponsors on notice.
“While we can’t be precise about the extent of the risk of non-reporting (that may occur), I do think the conclusions are broadly correct,” said Nicholas DeVito, a researcher at the EBM DataLab at Oxford University. Earlier this year, he co-authored a paper in The Lancet showing only 41% of clinical trial results were reported on time in the U.S. and 36% went unreported to ClinicalTrials.gov.
“I especially think (the TranspariMED) recommendations – that the national competent authorities should take proactive steps to inform these sponsors of their responsibilities under EU guidelines, especially given the urgent nature of Covid research – would be a very good step to at least ensure ignorance would not be an excuse if non-reporting does turn out to be an issue.”
The issue is percolating elsewhere.
Earlier this year, the European Court of Justice sided with the European Medicines Agency in its bid to provide access to clinical trial data and other types of information as part of a hotly contested transparency policy. Senderovitz, who is on the management group of the Heads of Medicines Agencies, told us he plans to place concerns about Covid-19 trial results on the upcoming meeting agenda.
In the U.K., meanwhile, the chair of the Science and Technology Committee in Parliament last year renewed a call for sanctions on companies and universities that fail to report results. The previous year, the same lawmaker issued a blistering report criticizing the lack of transparency and urged the U.K.’s Health Research Authority to enforce rules and impose penalties, although no steps have been taken.
And in the U.S., a federal judge earlier this year ruled that the Department of Health and Human Services and the National Institutes of Health had frustrated the intent of a federal law and ordered the agencies to require reporting and posting of missing trial data on the ClinicalTrials.gov database. However, the NIH and the Food and Drug Administration have never imposed any penalties on violators.
A year ago, an analysis found that clinical trial results from nearly one-third of hundreds of studies had not been disclosed over the previous two years by several of the most prestigious research universities in the U.S. The analysis was conducted by TranspariMED and the Universities Allied for Essential Medicines, a student-led organization concerned with access to medicines.
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