Rake, B. (2022). Controversies with Clinical Trial Regulations in Low- and Middle-Income Countries, In: Faintuch, J., Faintuch, S. (eds): Integrity of Scientific Research, Springer, Cham, 235–242


Low- and middle-income countries are increasingly selected as locations for international clinical trials. The consequences have been debated within and beyond the academic literature. Low- and middle-income countries are also referred to as nontraditional countries. This chapter reviews the extant literature related to this debate and identifies the three main—partially interrelated—concerns: a lack of contribution to building up local innovation capacity, a lack of local regulatory capacity, and the prevalence of questionable clinical research practices and fraud. A call for long-term capacity-building efforts of local researchers and regulators in nontraditional countries is a priority.