​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​