Dr. Till Bruckner, founder of TranspariMED, an initiative to end evidence distortion in medicine, said the organization was continually hearing from universities finding it difficult to upload trial results. So, they decided to take a closer look, he told us.
According to a report, launched by TranspariMED and Health Action International, more than half of due clinical trials are missing results on the European Medicines Agency’s (EMA) EU clinical trials register (EUCTR). Additionally, it is estimated that approximately half of these trials also have not reported results to other registries, such as ClinicalTrials.gov.
At Universities specifically, the report found that the institutions performed worse, failing to post more than 80% of trial results. Though improvements have been made following pressure from TranspariMED as well as British parliamentarians and the AllTrials campaign.
“A regulator's job should be to actively support compliance, but the system we found seems designed to do the opposite,” said Bruckner. “To start with, universities don't understand the rules because EMA and national regulators haven't communicate them clearly. Then, when a trial's results do become overdue, EMA does not even notify the sponsor.”
Several seemingly minor issues such as this were found, Bruckner said, which when compounded, “seriously hinder compliance.” Accordingly, TranspariMED created a list of small, simple fixes the EMA could make, such as sending sponsors reminder messages a few months before results are due.
The good news, Bruckner said, “is that EMA's first reaction to the report has been very positive."
Introduced in 2016, agency’s data publication policy still faces both praise and concern, and was challenged last year when several companies claimed the regulation undermines commercial interest. However, the transparency regulation was upheld in what were called “landmark rulings.”
Ancel La Santos Quintano, senior policy advisor, EU projects, Health Action International, said the EMA’s proactive publication policy is “a big step forward.” Still, she noted the organization’s concern that companies could cite anonymization as a reason to redact important data from the reports.
“The redaction of information—such that on adverse event data—can compromise the scientific utility of the reports and, in turn, undermine the overall policy,” Quintano told us. “Redactions of any kind should be kept to a minimum, and companies be sent a strong signal that they must use anonymization techniques that preserve the utility of the reports.”
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