Developing World Bioethics 9 (2):74-80 (2009)
Abstract |
Objective: Ethical guidelines are designed to ensure benefits, protection and respect of participants in clinical research. Clinical trials must now be registered on open-access databases and provide details on ethical considerations. This systematic survey aimed to determine the extent to which recently registered clinical trials report the use of standard of care and post-trial obligations in trial registries, and whether trial characteristics vary according to setting. Methods: We selected global randomized trials registered on http://www.clinicaltrials.gov and http://www.controlled-trials.com. We searched for intervention trials of HIV/AIDS, malaria, and tuberculosis from 9 October 2004, the date of the most recent version of the Helsinki Declaration, to 10 April 2007. Results: We collected data from 312 trials. Fifty-eight percent (58%, 95% CI = 53 to 64) of trial protocols report informed consent. Fifty-eight percent (58%, 95% CI = 53 to 64) of trials report active controls. Almost no trials (1%, 95% CI = 0.5 to 3) mention post-trial provisions. Most trials measure surrogate outcomes. Twenty percent (20%, 95% CI = 16 to 25) of trials measure patient-important outcomes, such as death; and the odds that these outcomes are in a low income country are five times greater than for a developed country (odds ratio (OR) 5.03, 95% CI = 2.70 to 9.35, p = < 0.001). Pharmaceutical companies are involved in 28% (CI = 23 to 33) of trials and measure surrogate outcomes more often than nonpharmaceutical companies (OR 2.45, 95% CI = 1.18 to 5.09, p = 0.31). Conclusion: We found a large discrepancy in the quality of reporting and approaches used in trials in developing settings compared to wealthier settings.
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Keywords | HIV/AIDS clinical trials Africa developing world bioethics developing world benefit sharing bioethics |
Categories | (categorize this paper) |
DOI | 10.1111/j.1471-8847.2008.00233.x |
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References found in this work BETA
Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries.Peter Lurie & Sidney M. Wolfe - 2012 - In Stephen Holland (ed.), Arguing About Bioethics. Routledge. pp. 479.
Ethical Review of Health Research: A Perspective From Developing Country Researchers.A. A. Hyder - 2004 - Journal of Medical Ethics 30 (1):68-72.
The Standard of Care Debate: Against the Myth of an "International Consensus Opinion".U. Schuklenk - 2004 - Journal of Medical Ethics 30 (2):194-197.
Research in the Ranks: Vulnerable Subjects, Coercible Collaboration, and the Hepatitis E Vaccine Trial in Nepal.Jason Andrews - 2006 - Perspectives in Biology and Medicine 49 (1):35-51.
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Citations of this work BETA
Reasons Why Post-Trial Access to Trial Drugs Should, or Need Not Be Ensured to Research Participants: A Systematic Review.N. Sofaer & D. Strech - 2011 - Public Health Ethics 4 (2):160-184.
Engaging Diverse Social and Cultural Worlds: Perspectives on Benefits in International Clinical Research From South African Communities.Olga Zvonareva, Nora Engel, Eleanor Ross, Ron Berghmans, Ames Dhai & Anja Krumeich - 2015 - Developing World Bioethics 15 (1):8-17.
Post-Trial Access to Study Medication: A Brazilian E-Survey with Major Stakeholders in Clinical Research.Sonia M. Dainesi & Moises Goldbaum - 2012 - Journal of Medical Ethics 38 (12):757-762.
Human Dignity as a Basis for Providing Post-Trial Access to Healthcare for Research Participants: A South African Perspective.Pamela Andanda & Jane Wathuta - 2018 - Medicine, Health Care and Philosophy 21 (1):139-155.
Canadian Research Ethics Board Members’ Attitudes Toward Benefits From Clinical Trials.Kori Cook, Jeremy Snyder & John Calvert - 2015 - BMC Medical Ethics 16 (1):1-7.
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