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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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A practical suggestion

Posted by AdamJacobs on 12 Apr 2012 at 10:32 GMT

There are undoubtedly great benefits in making raw data from clinical trials more widely available.

However, the problem of maintaining patient confidentiality that Eichler et al identify is an important one, and needs to be taken seriously if we are to maintain the trust of patients who participate in research. I'm not sure what patients would think of the suggestion to maintain "adequate" standards rather than "unrealistically high standards" of data confidentiality. Personally, if I were a patient, I would expect my data to be treated with extremely high standards of confidentiality.

There is, I think, a good solution to this problem for trials that have not yet started. We should routinely add a paragraph to informed consent documents for clinical trials explaining that raw data from the study will be made public, and exactly what that raw data will contain, so that patients can make their own judgements about how serious is the risk that they could be identified. We do not have the right to make that judgement for them.

What to do with completed trials that didn't ask patients for that explicit consent to sharing raw data is a trickier problem, for which I can't think of any easy answers.

Competing interests declared: My company provides consultancy services to pharmaceutical companies in the area of data management and statistics.