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

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

Health Policy, 2017, vol. 121, issue 9, 971-977

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.

Keywords: Clinical trials; Good clinical practice (GCP); Harmonization; Institutional change; Institutional work; Public supervision (search for similar items in EconPapers)
Date: 2017
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Persistent link: https://EconPapers.repec.org/RePEc:eee:hepoli:v:121:y:2017:i:9:p:971-977

DOI: 10.1016/j.healthpol.2017.06.008

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