He cites the ich us food and drug administration 2001

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Unformatted text preview: d’’ (Vastag 2000:2983). He cites the ICH (U.S. Food and Drug Administration 2001) as the alternative and more authoritative guideline on the ethics of placebo use. This guideline states, ‘‘Whether a particular placebo controlled trial of a new agent will be acceptable to subjects and investigators when there is a known effective therapy is a matter of patient, investigator, and IRB judgement, and acceptability may differ among ICH regions. Acceptability could depend on the specific trial design and population chosen’’ (Temple 2002:213, emphasis added). In other words, the ethical standard for the world was claimed to be variability. Temple’s support for the placebo trial was ostensibly guided by a concern for generating high-quality scientific data. His reaction is also indicative of how regulatory regimes can influence the definition of experimental groups. Let me briefly trace the logic of this relation. The alternative to the placebo-control is the active-control trial. Its purpose is to compare a new drug with a standard one, to show superiority of the new drug to the activ...
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