Putting the “good” into Good Clinical Practice

Symons, Tanya; Webb, Steve; Zalcberg, John R

doi:10.5694/mja2.50908

Topics

Statistics, epidemiology and research design

Current Good Clinical Practice guidelines are bureaucratic and should align with less burdensome examples of international trial policy

Clinical trials must be conducted in ways that protect participants and produce reliable results. Both are central tenets of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guideline.1 The ICH GCP guideline was developed to harmonise the conduct of trials across world regions and, since the mid‐1990s, its core principles have provided the bedrock for trial conduct. However, the devil is in the detail and, in the case of the ICH GCP guideline, that detail (and the interpretation of each word) has far‐reaching consequences.

1 University of Sydney, Sydney, NSW
2 Royal Perth Hospital, Perth, WA
3 Monash University, Melbourne, VIC

Correspondence: tanya.symons@sydney.edu.au

Competing interests:

No relevant disclosures.

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