The DOI matches its Crossref record; 13 of the 13 references it cites were found in a registry or an index.
Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries
Abstract
There has been considerable controversy about the ethics of clinical trials that are sponsored or conducted by groups in industrialized countries but carried out in developing countries.18 The National Bioethics Advisory Commission, of which we serve as chairman and executive director, respectively, has recently addressed these and related issues.9 International collaborative research covers a broad spectrum of methods, topics, and research strategies. In this essay, we discuss ethical issues in the design and conduct of clinical trials in developing countries. In particular, we focus on phase 3 and other drug trials that, if successful, can lead to the use . . .
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“Even within the paucity of literature on conducting clinical trials in low resource countries, the literature mostly relates to ethical issues [19, 26–28].”
From Barriers for conducting clinical trials in developing countries—A systematic review (2018) · cites this paper as [27]
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Cites
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The Ethics of Clinical Research in the Third World
Angell, M. (1997) · New England Journal of Medicine · doi:10.1056/nejm199709183371209 · Cited by 863
Ethical Complexities of Conducting Research in Developing Countries
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Research works printed but not linked: 1
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Ethical and Scientific Implications of the Globalization of Clinical Research
Glickman, S. W., McHutchison, J. G., Peterson, E. D., Cairns, C. B., Harrington, R. A., Califf, R. M., & Schulman, K. A. (2009) · New England Journal of Medicine · doi:10.1056/nejmsb0803929 · Cited by 710
Barriers for conducting clinical trials in developing countries—A systematic review
Alemayehu, C., Mitchell, G., & Nikles, J. (2018) · International Journal for Equity in Health · doi:10.1186/s12939-018-0748-6 · Cited by 406
The Ethics of Placebo-Controlled Trials — A Middle Ground
Emanuel, E. J., & Miller, F. G. (2001) · New England Journal of Medicine · doi:10.1056/nejm200109203451211 · Cited by 354
Fair Benefits for Research in Developing Countries
(2002) · Science · doi:10.1126/science.1076899 · Cited by 200
Giuliani, E., & Macchi, C. (2013) · Cambridge Journal of Economics · doi:10.1093/cje/bet060 · Cited by 151
Metadata
- Authors
- Shapiro, H. T., & Meslin, E. M.
- Affiliations
- National Institutes of Health (US)
- ORCID
- Meslin, Eric M.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2001-07-12
- Volume
- 345
- Issue
- 2
- Pages
- 139-142
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2065625460
- Cited by
- 204
- References
- 13
- Citations by year
- 2026: 1 · 2025: 2 · 2023: 2 · 2022: 2 · 2021: 3 · 2020: 8 · 2019: 4 · 2018: 5 · 2017: 9 · 2016: 7 · 2015: 6 · 2014: 6 · 2013: 13 · 2012: 8
- FWCI
- 15.50
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
- Keywords
- clinical trial ethics, developing countries, international collaborative research, research ethics oversight, National Bioethics Advisory Commission
- MeSH terms
- Clinical Trials as Topic, Developing Countries, Ethics, Medical, Helsinki Declaration, Humans, Research Design, United States, Ethical Review, Vulnerable Populations, Internationality
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