Reporting of informed consent, standard of care and post-trial obligations in global randomized intervention trials: A systematic survey of registered trials
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
Developing World Bioethics 9 (2):74-80 (2009)
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.
|Keywords||HIV/AIDS clinical trials Africa developing world bioethics developing world benefit sharing bioethics|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
Jason Andrews (2006). Research in the Ranks: Vulnerable Subjects, Coercible Collaboration, and the Hepatitis E Vaccine Trial in Nepal. Perspectives in Biology and Medicine 49 (1):35-51.
Jennifer L. Gold & David M. Studdert (2005). Clinical Trials Registries: A Reform That is Past Due. Journal of Law, Medicine and Ethics 33 (4):811-820.
A. A. Hyder (2004). Ethical Review of Health Research: A Perspective From Developing Country Researchers. Journal of Medical Ethics 30 (1):68-72.
Peter Lurie & Sidney M. Wolfe (2012). Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries. In Stephen Holland (ed.), Arguing About Bioethics. Routledge. 479.
U. Schuklenk (2004). The Standard of Care Debate: Against the Myth of an "International Consensus Opinion". Journal of Medical Ethics 30 (2):194-197.
Citations of this work BETA
No citations found.
Similar books and articles
Sven Ove Hansson (2006). Uncertainty and the Ethics of Clinical Trials. Theoretical Medicine and Bioethics 27 (2):149-167.
Stanley H. Shapiro, Charles Weijer & Benjamin Freedman, Reporting the Study Populations of Clinical Trials. Clear Transmission or Static on the Line?
Charles Weijer, Benjamin Freedman, Abraham Fuks, James Robbins, Stanley Shapiro & Myriam Skrutkowska, What Difference Does It Make to Be Treated in a Clinical Trial? A Pilot Study.
Piotr Zaborowski & Adam Górski (2004). Informed Consent and the Use of Placebo in Poland: Ethical and Legal Aspects. Science and Engineering Ethics 10 (1):167-178.
R. Macklin (2010). Intertwining Biomedical Research and Public Health in HIV Microbicide Research. Public Health Ethics 3 (3):199-209.
Bernard Lo & Lindsay Parham (2010). Resolving Ethical Issues in Stem Cell Clinical Trials: The Example of Parkinson Disease. Journal of Law, Medicine and Ethics 38 (2):257-266.
Udo Schuklenk (2007). HIV Vaccine Trials: Reconsidering the Therapeutic Misconception and the Question of What Constitutes Trial Related Injuries. Developing World Bioethics 7 (3).
Maurie Markman (2004). The Research Misconception. International Journal of Applied Philosophy 18 (2):241-252.
David Wendler (2009). Must Research Participants Understand Randomization? American Journal of Bioethics 9 (2):3 – 8.
Jane L. Hutton & Richard E. Ashcroft (2000). Some Popular Versions of Uninformed Consent. Health Care Analysis 8 (1):41-53.
Added to index2009-01-28
Total downloads8 ( #158,446 of 1,096,180 )
Recent downloads (6 months)1 ( #218,857 of 1,096,180 )
How can I increase my downloads?