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Controversies with Clinical Trial Regulations in Low- and Middle-Income Countries

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Integrity of Scientific Research

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Abstract

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.

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Authors and Affiliations

  1. Maynooth University, Maynooth, Ireland

    Bastian Rake

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  1. Bastian Rake
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Correspondence to Bastian Rake .

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  1. Hospital das Clinicas, University of Sao Paulo, Sao Paulo, São Paulo, Brazil

    Joel Faintuch

  2. Beth Israel Deaconess Medical Center & Harvard Medical School, Boston, MA, USA

    Salomão Faintuch

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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. https://doi.org/10.1007/978-3-030-99680-2_23

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  • DOI: https://doi.org/10.1007/978-3-030-99680-2_23

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