The CIOMS consensus report on clinical research in resource-limited settings
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Abstract
Background. Responsible clinical research drives the advancement of healthcare. Despite tremendous improvements in the global
research and development environment since the 1950s, low- and middle-income countries (LMICs) are often left behind. There are several reasons for this. Firstly, operational, social, ethical and regulatory challenges in LMICs make it difficult for researchers to conduct clinical studies in those settings in line with international requirements. Secondly, many people living in low-resource settings distrust research because some past studies have not benefited the participants or the communities involved.
Objectives. To present the consensus recommendations by a Council for International Organizations of Medical Sciences (CIOMS) Working Group on how to advance good-quality, ethical clinical research in resource-limited settings.
Methods. CIOMS convened a Working Group of senior scientists from drug regulatory authorities, the pharmaceutical industry, publicprivate partnerships for product development, and academia.
Results. This article summarises the Working Group’s report.
Conclusion. The report recommendations can foster the creation of a more enabling ecosystem for clinical research and promote
collaboration between policymakers, regulators, researchers and funders.
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References
Council for International Organizations of Medical Sciences (CIOMS). Clinical Research in Resource-limited Settings: A Consensus by a CIOMS Working Group. Geneva: CIOMS, 2021. https://doi.org/10.56759/cyqe7288 (accessed 14 November 2022).
Institute for Health Metrics Evaluation. Global Health Data Exchange. https:// vizhub.healthdata.org/gbd-compare/ (accessed 11 October 2021).
Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Health-related Research Involving Humans. Geneva: CIOMS, 2016. https://doi.org/10.56759/rgxl7405 (accessed 14 November 2022).
TRUST Consortium. Global Code of Conduct for Research in Resource-poor Settings. https://www.globalcodeofconduct.org/wp-content/uploads/2018/05/ Global-Code-of-Conduct-Brochure.pdf (accessed 6 March 2022).
Lang TA, White NJ, Tran HT, et al. Clinical research in resource-limited settings: Enhancing research capacity and working together to make trials less complicated. PLoS Negl Trop Dis 2010;4(6):e619. https://doi.org/10.1371/journal. pntd.0000619
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice. E6(R2). Geneva: ICH, 2016. https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf (accessed 11 October 2021).
World Health Organization. Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation. Geneva: WHO, 2015. https://apps.who.int/iris/ handle/10665/43392 (accessed 11 October 2021).
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Global Health; Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines; Cuff P, Wood AJ, eds. Regulating Medicines in a Globalised World: The Need for Increased Reliance Among Regulators. Washington, DC: National Academies Press, 2019. https://doi. org/10.17226/25594