Approximately half of all clinical trials registered in the European Union have not reported results on the European Union Clinical Trials Register as required by the European Commission, according to a study published September 12 in The BMJ. While 68 percent of pharmaceutical companies disclosed their trial data, only 11 percent of academic institutions including hospitals and universities had done so.
“This problem strikes to the heart of evidence based medicine. We cannot make informed choices about which treatments work best, as doctors and patients, unless all results are reported,” coauthor Ben Goldacre of the University of Oxford says in a statement. A new tracker was launched along with the study to help keep a check on clinical trial reporting in the European Union (EU).
The EU guidelines dictate that clinical trials registered with the EU Clinical Trials Register since 2004 must report their results within a year after the study’s conclusion. According to Reuters, advocates say making data reporting mandatory is essential to transparent science.
The most severe defaulters were the University of Helsinki in Finland and the University of Nottingham in the UK, with the results from zero out of 12 and one out of 17 trials reported, respectively. In the same statement, Síle Lane, head of international campaigns and policy for the UK charity Sense about Science, questioned why such institutions should continue to run trials.
According to Science, the University of Dundee and the University of Oxford were on the other end of the spectrum with 82 percent and 77 percent compliance with trial reporting, respectively.
According to Pacific Standard, the European Medicines Agency, which manages the EU Clinical Trials Register, is crafting a protocol to identify late trials and notify academic institutions and companies of their delay, writes Sophie Labbé, a spokeswoman for the agency, in an email. The agency is incapable of implementing legal action against the defaulting organization.
According to Quartz, the researchers pushed out a tracker in early 2018 to record reporting compliance for US trials, finding that 59.1 percent of trials are compliant with US law and the US government could seek more than $600 million in penalties from laggers. However, “Compliance rates have not improved . . . over the six months since we started tracking,” Goldacre tells Pacific Standard.