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Apr 4, 2014

EU Will Require Publication of Trial Results

  • The European Parliament has overwhelmingly passed a law requiring all biopharmas and academic researchers to make public all results of clinical trials on the continent. 

    By a 594–17 vote, with 13 abstentions, members of Parliament approved the new EU Clinical Trials Regulation. It requires trial sponsors to post full reports, including those of failed trials, once a drug is approved for marketing by the European Commission.

    But the law also throws several proverbial bones to biopharmas. The measure was revised from its original version by allowing companies to publish only detailed summaries of their trials in a public database until the drug under study is EC-approved. Also, biopharmas will be able under the new law to submit applications for trial approval once through a single EU portal, with member states having to approve a single decision and a fixed deadline for review.

    A final version of the regulation is expected to be published this summer, and take effect in 2016.

    The law was introduced into Parliament by MEP Glenis Willmott of the U.K., but picked up key support from BMJ (formerly the British Medical Journal), which joined the Cochrane Collaboration in advocating for the measure since last year through Twitter, using the hashtag #AllTrials.

    Supporters such as #AllTrials argued that selective reporting of clinical trials hindered research and only protected companies from embarrassment. But the European Federation of Pharmaceutical Industries and Associations (EFPIA), and its U.S. Counterpart, Pharmaceutical Research and Manufacturers Association (PhRMA), had initially opposed the measure.

    The two industry groups cited the potential for invading patient privacy, while insisting they were committed to greater trial data disclosure in a manner that upheld privacy. EFPIA and PhRMA agreed effective January 1 to increase the amount of information available to researchers, patients and members of the public.

    Both groups agreed that their members would share, starting this year, patient-level clinical trial data, study-level clinical trial data, full clinical study reports, and protocols from clinical trials in patients for medicines approved in the U.S. and EU—but only with “qualified scientific and medical researchers” upon request, and subject to terms the groups said were necessary to protect patient privacy and confidential commercial information. Researchers who obtain access to such clinical trial data will be expected to publish their findings, the groups added.

    EFPIA issued a statement welcoming the new measure: “EFPIA believes the new legislative framework will help foster a more harmonized approach to clinical trials in the EU, with a single submission and overall streamlined assessment process. EFPIA also welcomes the legislation’s approach to transparency, which respects the need to protect personal patient data and commercially confidential information.”

    “It is critical that the Commission and EMA interpret the Clinical Trial Regulation in a manner that respects patient privacy, the integrity of regulatory decision-making, and incentives for companies to make long-term investments in biomedical research,” EFPIA added.

    Steve Bates, CEO of the BioIndustry Association (BIA), a U.K.-based industry group, said it would work to sure the law fulfills one of biopharma’s priorities across Europe—improving the EU’s attractiveness as a location for clinical research.

    “For that to happen we now need to ensure the legislation delivers simplification, efficiency, standardization and speed in starting clinical trials,” Bates said in a statement.

    Bates added: “The UK is well placed to take full advantage of the benefits of the new legislation as we have the most vibrant clinical development ecosystem in Europe and excellent and progressive partners in the Medicines and Healthcare Products Regulatory Agency (MHRA), Health Research Authority (HRA) and the National Health Service (NHS).”



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