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Cochrane: EU to enforce transparency in drug studies

In the EU, more than 4,000 drug studies currently do not meet the applicable requirements for the timely publication of results. 18 signatories wrote an open letter to the licensing authorities to ensure compliance with the rules on study transparency.

Results of thousands of studies not yet published

In the European Union, more than 4,000 drug studies currently do not meet the applicable requirements for the timely publication of results. Cochrane Germany, together with 17 other signatories, is therefore campaigning for compliance with long-established rules on study transparency in an open letter to the European approval authorities

In many countries around the world, including those in the European Union, there have long been clear guidelines for the registration of clinical studies and the timely publication of the results (EU Regulation 536/2014 of April 16, 2014). However, according to the "EU Trials Tracker" website, the results for 4,046 of 13,563 (almost 30 percent) of all registered European drug trials are currently overdue. This contradicts the requirements in the EU for the transparency of such studies. Results should be published within one year of the completion of a study. Delayed publication creates gaps in the evidence base on important medical issues, making it more difficult for doctors and health authorities to assess how safe and effective drugs are. Ultimately, this slows down medical progress and puts patients at risk.

It is the task of the national approval authorities in the individual EU countries to ensure that pharmaceutical companies, universities and hospitals (so-called study sponsors) publish the results of clinical studies on time. But many authorities do little to enforce compliance with applicable regulations.

An open letter to the EU approval authorities calls for minimum standards

This is precisely what an open letter from 18 non-governmental organizations calls for to the Heads of Medicines Agencies (HMA), an association of national drug approval authorities in the EU, whose signatories include Cochrane International and the Cochrane Centers in Austria and Sweden, as well as Cochrane Germany. The letter warns that inaccessible clinical trial results "have significant potential to harm European patients, taxpayers and public health. Many sponsors remain unaware of their obligation to publish trial results," the letter said. The HMA should demand the following three minimum standards from the national authorities of the EU (in Germany these are the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute:

  • Contacting all sponsors of completed studies for which results are overdue
  • As part of so-called pharmacovigilance inspections by the authorities of study sponsors, compliance with the rules for the disclosure of study results should be checked
  • Systematic review of the completion status of all clinical studies

Implementing the suggested steps would require minimal resources, but would bring significant patient benefits, argues the letter. He points out that each of the proposed measures is already being successfully implemented by individual regulators, which proves their feasibility. "If study results are not made available to science in a timely manner, good evidence-based health care is hardly possible. Ultimately, this endangers very specific sick people," comments Jörg Meerpohl, Director of Cochrane Germany.

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Esanum is an online network for licensed doctors

Esanum is the medical platform on the Internet. Here doctors have the opportunity to get in touch with a large number of colleagues and to exchange interdisciplinary experiences. Discussions include cases and observations from practice as well as news and developments from everyday medical practice.

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