Accommodating cultural differences in the International Conference of Harmonisation Good Clinical Practice guidelines

Introduction

The International Conference on Harmonisation (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use is a collaborative effort between regulatory authorities and the pharmaceutical industry to establish guidelines for pharmaceutical products.1 The ICH Good Clinical Practice (GCP) guidelines were implemented in 1997 to standardise the management of clinical trials. While intended to harmonise regulatory decision-making among ICH members—and used to guide research in low-income and middle-income countries (LMICs)—it has been argued that the ICH GCP guidelines were developed through informal consensus less rooted in scientific evidence.2 If GCP guidelines are truly meant to serve global interests, they must involve all relevant stakeholders, including researchers, sponsors, regulators, ethical reviewers and patients’ representatives, particularly those from LMICs. The absence of perspectives of LMIC researchers is perhaps one of the main critiques of these well-intentioned guidelines.

In LMICs, sociopolitical issues, poverty, healthcare inequities and a lack…

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