Ethical considerations in industry-sponsored multiregional clinical trials.
During the last several decades, the scientific and ethics communities have addressed important ethical issues in medical research, resulting in the elaboration and adoption of concepts, guidelines, and codes. Ethical issues in the conduct of Multiregional Clinical Trials have attracted significant attention mainly in the last two decades. With the globalization of clinical research and the rapid expansion to countries with a limited tradition of biomedical research, sponsors must proactively address local ethical issues, the adequacy of oversight as well as the applicability and validity of data, and scientific conclusions drawn from diverse patient populations. This paper highlights some core ethical principles and milestones in medical research, and, from an industry perspective, it discusses ethical issues that the clinical trial team may face when conducting Multiregional Clinical Trials (MRCT, clinical trials conducted at sites located across multiple geographic regions of the world). This paper further highlights the areas of consensus and controversies and proposes points to consider.
Ibia
Ekopimo
E
Merck & Co., Inc., Whitehouse Station, NJ, USA. Ekopimo_ibia@merck.com
Binkowitz
Bruce
B
Saillot
Jean-Louis
JL
Talerico
Steven
S
Koerner
Chin
C
Ferreira
Irene
I
Agarwal
Anupam
A
Metz
Craig
C
Maman
Marianne
M
D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence; D026661:Clinical Trials Data Monitoring Committees; D016265:Conflict of Interest; D003906:Developing Countries; D004345:Drug Industry / Q000941:ethics*; D026724:Ethical Review; D028744:Ethics Committees, Research; D005843:Geography; D033161:Government Regulation; D017408:Guidelines as Topic; D006381:Helsinki Declaration; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D038622:Internationality; D015337:Multicenter Studies as Topic / Q000941:ethics*; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D015203:Reproducibility of Results; D012107:Research Design; D012935:Social Justice / Q000941:ethics