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Open Clinical Trial Data for All? A View from Regulators

  • Hans-Georg Eichler mail,

    Affiliation: European Medicines Agency (EMA), London, United Kingdom

  • Eric Abadie,

    Affiliations: European Medicines Agency (EMA), London, United Kingdom, Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) Saint-Denis, France

  • Alasdair Breckenridge,

    Affiliation: Medicines and Healthcare products Regulatory Agency (MHRA), London, United Kingdom

  • Hubert Leufkens,

    Affiliations: European Medicines Agency (EMA), London, United Kingdom, Medicines Evaluation Board (CBG-MEB), Den Haag, The Netherlands

  • Guido Rasi

    Affiliation: European Medicines Agency (EMA), London, United Kingdom

  • Published: April 10, 2012
  • DOI: 10.1371/journal.pmed.1001202

Reader Comments (2)

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Disappointing article from the Regulators

Posted by DCoyne on 22 May 2012 at 21:32 GMT

The regulators accept without question that their analyses of the clinical trial results are correct. Yet the Tamiflu story and the EPO-anemia story both reflect at best incomplete analyses of risk-benefit, or worse, erroneous analyses. They also reflect a failure of Pharma and Regulatory Authorities to disseminate timely information to the Medical community and patients.

The regulators' article largely offers strawmen arguments which they then attack:

1. they are worried about patient confidentiality (virtually none of the patient specific unidentified data gets into the trial reports submitted by Pharma to regulators). A single read-through could assure no patients are identified.
2. They are worried non-conflicted scientists would perform bad evaluations. Can't the same be said of some regulatory reviews? It is inappropriate for scientists at Regulatory Authorites to prevent others from reviewing and questioning their interpretations. This would effectively place their desire for authority above the protection of patients exposed to drugs.

The actual important issues are ignored by the Regulators, including important trial results (not - reanalyses) are NOT released to the Medical community despite being present in the submitted trial reports, and billions are spent by the public on medical care that could have been avoided by release of the trial reports.

It appears the Regulators are dependent on Pharma and may be unwilling to undergo frequent scrutiny. Sunlight is the best disinfectant, and release of the HUMAN clinical trial reports that by law are submitted to the FDA and EMEA are at least a starting point for cleaning up the system.

The authros should address why they think that is a bad idea. I hope they do not, and would demand action now.

Competing interests declared: see my recent publication on the withholding of predefined clinical trial endpoints in the first major EPO outcomes trial at