Local clinical trials in low-to-middle income countries as an ethical alternative to high-income country-led trials

28 April 2024, Version 1
This content is an early or alternative research output and has not been peer-reviewed by Cambridge University Press at the time of posting.

Abstract

Background: Most clinical trials are registered to be conducted in high-income countries (HIC), whereas low-to-middle income countries (LMIC) account for 32%. Building a non-HIC dependent clinical trial research capacity in LMIC is a priority. However, certain ethical principles could be jeopardized in the process. Objective: To explore conditions in LMIC to ethically conduct clinical trials independently from HIC. Material and Methods: Analysis the ten Principles and Benchmarks for Ethical Clinical Research by Emanuel EJ, et al. A non-systematic search of the literature was carried out to identify studies that cover problems and potential solutions to conduct independent trials in LMICs. Results: Three studies were coincided with the notion that HIC-led trials often do not guarantee equitable distribution of funds and publication credits. Alternative trial designs are proposed. Conclusion: International collaboration between LMIC and HIC based on equity between partners could harmonize ethical principles compared to strictly locally-initiated or HIC-led trials.

Keywords

Ethics
Research
Socioeconomic Factors
Research Support

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