Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 1: Ethical and Scientific Issues

By R. Temple, S. Ellenberg. Annals of Internal Medicine, 2000

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Comparative Effectiveness and Safety of Medications for Type 2 Diabetes: An Update Including New Drugs and 2-Drug Combinations (2011, background): “Because the current review is an update of a review that had included placebo-controlled trials, for most drug comparisons this was probably true (50).”
Combating antimicrobial resistance: policy recommendations to save lives. (2011, background): “Superiority Trials of Antibiotics There are two major categories of superiority clinical trials [120, 121].”
The revision of the Declaration of Helsinki: past, present and future. (2004, background): “The debate in the literature over the ethics of placebo controls has raged for at least the past decade between the proponents of ‘active-control orthodoxy’ such as Rothman, Michels and Weijer [19–21] and those supporting ‘placebo orthodoxy’ such as Levine [22] and Temple [23].”
Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial. (2003, methodology): “Although no standard or universally-accepted basis exists for choosing such a margin,(14,16) a noninferiority boundary preserving at least 50% of the standard drug effect as used in this study, has precedent(15,29,30) and is clinically relevant.(16) The findings of the imputed CI method prespecfied ”