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Perspective

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Open Clinical Trial Data for All? A View from Regulators

  • Hans-Georg Eichler mail,

    hans-georg.eichler@ema.europa.eu

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

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  • Eric Abadie,

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

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  • Alasdair Breckenridge,

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

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  • Hubert Leufkens,

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

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  • Guido Rasi

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

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

About the Authors

Hans-Georg Eichler, Eric Abadie, Hubert Leufkens, Guido Rasi
European Medicines Agency (EMA), London, United Kingdom
Eric Abadie
Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) Saint-Denis, France
Alasdair Breckenridge
Medicines and Healthcare products Regulatory Agency (MHRA), London, United Kingdom
Hubert Leufkens
Medicines Evaluation Board (CBG-MEB), Den Haag, The Netherlands

Corresponding Author

Email: hans-georg.eichler@ema.europa.eu

Competing Interests

All authors work for drug regulatory agencies. The authors have declared that no other competing interests exist. The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agencies, or the committees or working parties of the regulatory agencies the authors work for.

Author Contributions

Wrote the first draft of the manuscript: HGE. Contributed to the writing of the manuscript: HGE EA AB HL GR. ICMJE criteria for authorship read and met: HGE EA AB HL GR. Agree with manuscript results and conclusions: HGE EA AB HL GR.