EMA’s Guido Rasi publishes article promoting clinical trial data openness

October 24 ,2013 | By Márcio Barra

Back in June this year, The European Medicines Agency (EMA) released for consultation a draft policy on access and transparency of clinical-trial data, detailing three different levels of access according to the type of data, alongside rules for publication and use.

This new draft policy came under fire from elements of the pharmaceutical industry, as the industry felt that, when the policy comes into effect in January 2013, confidential data from their medicines will be released, and harm investment in the development of new drugs. This has put the Agency at odds againts the pharmaceutical industry. This was especially noteworthy earlier this year, when EMA complied with freedom of information requests from UCB for data on AbbVie’s Humira, and from Boehringer Ingelheim for data on InterMune’s Esbriet. In reaction, both AbbVie and InterMune immediately appealed to the European court against the decisions, and at the same time sought – and won – injunctions granting them relief on a temporary basis, pending a final court decision.

In a personal response, EMA’s boss Guido Rasi, writing in the New England Journal of Medicine, has come out with an article entitled “Access to patient-level trial data – a boon to drug developers”, defending greater transparency for clinical trials. The article argues that EMA’s controversial policy to end data secrecy will “benefit the research-based biopharmaceutical industry…increase the efficiency of drug development, improve cost-effectiveness, improve comparative-effectiveness analysis, and reduce duplication of effort among trial sponsors”

Guido Rasi, Ema’s executive director since November 2011, has become one of the leading advocates for more transparency in the pharmaceutical industry. The article just published further cements his position, with him and his team, who include senior medical officer Hans-Georg Eichler and Biostatistician Frank Pétavy, providing several arguments for increased data transparency. These include:

  • Improvements in the design and analysis of subsequent trials, prompted by the creation of patient-level data databases that may inform future projects and research questions;
  • Information from past trials about the heterogeneity of treatment effects will help streamline drug development;
  • Wider data access will allow sponsors to present more robust comparative-effectiveness information about their product soon after licensing, at a limited cost as compared with that of head-to-head trials;
  • Cut the repetition of trials that are condemned from the outset, as past clinical trials conducted by others may have already demonstrated the project’s futility.

The article ends on an concerned note, stating that “It is ironic that the organizations that most resist wider access to data are the ones that stand to benefit so much from greater transparency. “

In the meantime, demands for more transparency are growing. In Europe, The German’s Institute for Quality and Efficiency in Health Care has even recently complained that the EMA measures do not go far enough.

In the US, The U.S. Food and Drug Administration is considering new ways to increases data disclosure, while the U.S. Institute of Medicine will discuss clinical trial data sharing at a two-day meeting in Washington this week.


New England Journal of Medicine

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