EU Calls For Results Of All EU-based Clinical Trials To Be Added To Public Database

The European Commission and European Union medicines regulatory agencies sent an open letter to all sponsors of EU-based clinical trials to remind them of their obligation to publish the results of the trials – both positive and negative – in a public database.

The open letter by the European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) reminded sponsors that according to a 2012 EC guideline, clinical trial summary results are required to be published in the EU Clinical Trials Database, EudraCT, and that publishing these results is their direct responsibility.

“Transparency and public access to clinical trial results, whether positive or negative, are fundamental for the protection and promotion of public health,” the EMA said in a press release.

“In addition, for those medicines which are placed on the market or used in further clinical trials, it allows patients and healthcare professionals, or any other citizen, to find out more information about medicines they might be taking or prescribing,” it said.

The letter noted that out of the 27,093 completed clinical trials in the EudraCT database, 68.2 percent are in compliance with the EU publication rules and 31.8 percent have missing results, which the letter identified as “an encouraging trend.”

However, it added that “there is still significant progress to be made,” citing that reporting compliance for non-commercial sponsors is low at 23.6 percent, compared to that of commercial sponsors at 77.2 percent.

The letter particularly encouraged academic and other non-commercial sponsors “to post the results of their trials in EudraCT in order to maximise their valuable contribution to meet public health needs and to advance clinical research especially where commercial interest is weaker.”

“Underreporting in general and selective reporting of trials with positive outcome may lead to potentially avoidable redundancies in the conduct of clinical trials and compromise the economic and scientific efficiency of clinical research,” it warned. “In addition, unreported clinical trials with unfavourable outcome can have negative public health implications.”

Image Credits: European Medicines Agency.

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