Extending Clinical Equipoise to Phase 1 Trials Involving Patients: Unresolved Problems
Notwithstanding requirements for scientific/social value and risk/benefit proportionality in major research ethics policies, there are no widely accepted standards for these judgments in Phase 1 trials. This paper examines whether the principle of clinical equipoise can be used as a standard for ass...
| Authors: | ; |
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| Format: | Electronic Article |
| Language: | English |
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| Published: |
Johns Hopkins Univ. Press
2010
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| In: |
Kennedy Institute of Ethics journal
Year: 2010, Volume: 20, Issue: 1, Pages: 75-98 |
| Online Access: |
Presumably Free Access Volltext (lizenzpflichtig) Volltext (lizenzpflichtig) |
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| 520 | |a Notwithstanding requirements for scientific/social value and risk/benefit proportionality in major research ethics policies, there are no widely accepted standards for these judgments in Phase 1 trials. This paper examines whether the principle of clinical equipoise can be used as a standard for assessing the ratio of risk to direct-benefit presented by drugs administered in one category of Phase 1 study—first-in-human trials involving patients. On the basis of the supporting evidence for, and architecture of, Phase 1 studies, the articles offers two provisional conclusions: (1) the risks of drug administration in such trials cannot generally be justified on therapeutic grounds but by appeal to the social value of the research; and (2) a framework for adjudicating the ratio of risk/social-value must be developed. | ||
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