TY - JOUR
T1 - Accommodating cultural differences in the International Conference of Harmonisation Good Clinical Practice guidelines
AU - Memon, Rakhshi
AU - Shah, Bushra Ali
AU - Asif, Muqaddas
AU - Eylem-van Bergeijk, Ozlem
AU - Jidong, Dung Ezekiel
AU - Ike, Tarela Juliet
AU - Khoso, Ameer B.
AU - Kiran, Tayyeba
AU - Omar, Neha
AU - Lunat, Farah
AU - Miah, Jahanara
AU - Abdelhakim, Hend E.
AU - Rana, Mowadat Hussain
AU - Mashreky, Saidur Rahman
AU - Zadeh, Zainab F.
AU - Shahzad, Salman
AU - Ahmad, Ayesha
AU - Sharma, Deepali
AU - Rafiq, Noor ul Zaman
AU - Irshad, Sehrish
AU - Abudoush, Ahmad
AU - Devanand, Abeena Elena
AU - Tofique, Sehrish
AU - Nisa, Zaib un
AU - Malik, Hifza
AU - Chaudhry, Imran
AU - Chaudhry, Nasim
AU - Husain, Nusrat
AU - Edwards, Sarah J.L.
PY - 2025/12/19
Y1 - 2025/12/19
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/105026319635
U2 - 10.1136/jme-2024-110197
DO - 10.1136/jme-2024-110197
M3 - Editorial
SN - 0306-6800
VL - 52
SP - 285
EP - 286
JO - Journal of Medical Ethics
JF - Journal of Medical Ethics
IS - 5
ER -