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Effects of EU harmonization policies on national public supervision of clinical trials: A dynamic cycle of institutional change and institutional work

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  • van Oijen, Jacqueline C.F.
  • Grit, Kor J.
  • van de Bovenkamp, Hester M.
  • Bal, Roland A.

Abstract

The EU Clinical Trials Directive (EUCTD) and the EU Clinical Trials Regulation aim to harmonize good clinical practice (GCP) of clinical trials across Member States. Using the Netherlands as a case study, this paper analyzes how endeavours to implement the EUCTD set in motion a dynamic process of institutional change and institutional work. This process lead to substantial differences between policy and actual practice; therefore, it is important to learn more about the implementation of harmonization policies.

Suggested Citation

  • van Oijen, Jacqueline C.F. & Grit, Kor J. & van de Bovenkamp, Hester M. & Bal, Roland A., 2017. "Effects of EU harmonization policies on national public supervision of clinical trials: A dynamic cycle of institutional change and institutional work," Health Policy, Elsevier, vol. 121(9), pages 971-977.
    • Handle: RePEc:eee:hepoli:v:121:y:2017:i:9:p:971-977
    DOI: 10.1016/j.healthpol.2017.06.008
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    References listed on IDEAS

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    3. Rocco, Philip & Thurston, Chloe, 2014. "From metaphors to measures: observable indicators of gradual institutional change," Journal of Public Policy, Cambridge University Press, vol. 34(1), pages 35-62, April.
    4. Thelen,Kathleen, 2004. "How Institutions Evolve," Cambridge Books, Cambridge University Press, number 9780521546744, October.
    5. Thelen,Kathleen, 2004. "How Institutions Evolve," Cambridge Books, Cambridge University Press, number 9780521837682, October.
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    Cited by:

    1. Sam Crosby & Esther Rajadurai & Stephen Jan & Richard Holden & Bruce Neal, 2022. "The effects of government policies targeting ethics and governance processes on clinical trial activity and expenditure: a systematic review," Palgrave Communications, Palgrave Macmillan, vol. 9(1), pages 1-12, December.

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