Journal of Medical Ethics 38 (12):757-762 (2012)
Abstract |
Objectives To analyse the perspective of clinical research stakeholders concerning post-trial access to study medication. Methods Questionnaires and informed consents were sent through e-mail to 599 ethics committee (EC) members, 290 clinical investigators (HIV/AIDS and Diabetes) and 53 sponsors in Brazil. Investigators were also asked to submit the questionnaire to their research patients. Two reminders were sent to participants. Results The response rate was 21%, 20% and 45% in EC, investigators and sponsors’ groups, respectively. 54 patients answered the questionnaire through their doctors. The least informative item in the consent form was how to obtain the study medication after trial. If a benefit were demonstrated in the study, 60% of research participants and 35% of EC answered that all patients should continue receiving study medication after trial; 43% of investigators believed the medication should be given to participants, and 40% to subjects who participated and benefited from treatment. For 50% of the sponsors, study medication should be assured to participants who had benefited from treatment. The majority of responders answered that medication should be provided free by sponsors; investigators and sponsors believed the medication should be kept until available in the public health sector; EC members said that the patient should keep the benefit; patients answered that benefits should be assured for life. Conclusions Due to the study limitations, the results cannot be generalised; however, the data can contribute to discussion of this complex topic through analysing the views of stakeholders in clinical research in Brazil
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DOI | 10.1136/medethics-2011-100127 |
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References found in this work BETA
Post‐Trial Access to Antiretrovirals: Who Owes What to Whom?Joseph Millum - 2011 - Bioethics 25 (3):145-154.
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.
Should Post-Trial Provision of Beneficial Experimental Interventions Be Mandatory in Developing Countries?Z. Zong - 2008 - Journal of Medical Ethics 34 (3):188-192.
Subjects' Views of Obligations to Ensure Post-Trial Access to Drugs, Care and Information: Qualitative Results From the Experiences of Participants in Clinical Trials (EPIC) Study.N. Sofaer, C. Thiessen, S. D. Goold, J. Ballou, K. A. Getz, G. Koski, R. A. Krueger & J. S. Weissman - 2009 - Journal of Medical Ethics 35 (3):183-188.
Reporting of Informed Consent, Standard of Care and Post-Trial Obligations in Global Randomized Intervention Trials: A Systematic Survey of Registered Trials.Emma R. M. Cohen, Jennifer M. O'neill, Michel Joffres, Ross E. G. Upshur & Edward Mills - 2009 - Developing World Bioethics 9 (2):74-80.
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Citations of this work BETA
Attitudes Toward Post‐Trial Access to Medical Interventions: A Review of Academic Literature, Legislation, and International Guidelines. [REVIEW]Kori Cook, Jeremy Snyder & John Calvert - 2016 - Developing World Bioethics 16 (2):70-79.
Implementing Post-Trial Access Plans for HIV Prevention Research.Amy Paul, Maria W. Merritt & Jeremy Sugarman - 2018 - Journal of Medical Ethics 44 (5):354-358.
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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