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Appropriate evidence for adaptive marketing authorization

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Adaptive marketing authorization approaches may, in some instances, replace traditional binary regulatory decisions on drug approval with progressive reduction of uncertainty about the benefit–risk profile of a drug through iterative evidence gathering and evaluation. How should the nature of such evidence be determined?

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Acknowledgements

This work was funded by the Dutch Top Institute Pharma. This paper is based on a workshop organized by The Escher Project (a public–private partnership on the development and regulation of medicines) in Amsterdam, The Netherlands, in December 2012. It was supported by a background paper, which is provided as supplementary information S1.

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Authors and Affiliations

  1. The Escher Project, David de Wiedgebouw, Universiteitsweg 99, Utrecht, 3584CG

    Jean Philippe de Jong

  2. Exon Consultancy, The Netherlands

    Jean Philippe de Jong

  3. University Medical Center Utrecht, and Chief Scientific Officer, Julius Clinical Research Ltd, The Netherlands.,

    Diederick E. Grobbee

  4. University of Namur, Belgium

    Bruno Flamion

  5. Scientific, Regulatory and Manufacturing Policy Committee, European Federation of Pharmaceutical Industries and Associations, and at Eli Lilly & Company.,

    Susan R. Forda

  6. Dutch Medicines Evaluation Board and Professor of Pharmacoepidemiology, Utrecht University, The Netherlands

    Hubert G. M. Leufkens

Authors
  1. Jean Philippe de Jong
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  2. Diederick E. Grobbee
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  3. Bruno Flamion
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  4. Susan R. Forda
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  5. Hubert G. M. Leufkens
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Corresponding author

Correspondence to Jean Philippe de Jong.

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Competing interests

Susan Forda is an employee of Eli Lilly and company.

Supplementary information

Supplementary information S1 (box)

Towards appropriate levels of evidence (PDF 1153 kb)

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FURTHER INFORMATION

The Escher Project

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de Jong, J., Grobbee, D., Flamion, B. et al. Appropriate evidence for adaptive marketing authorization. Nat Rev Drug Discov 12, 647–648 (2013). https://doi.org/10.1038/nrd4114

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