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

  1. Robert Temple, MD; and
  2. Susan S. Ellenberg, PhD
  1. From the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland.
    1. Appendix Figure. Hypothetical results of five studies are shown. The result of each study is shown on the y-axis as the difference between treatments (E − E ), where represents the control and represents the test drug. A positive difference favors the standard drug. Error bars show hypothetical 95% CIs for these differences. Three possible noninferiority margins are shown (M0, M1, M2). For more explanation, see the .
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        Appendix Figure. Hypothetical results of five studies are shown. The result of each study is shown on the y-axis as the difference between treatments (E − E ), where represents the control and represents the test drug. A positive difference favors the standard drug. Error bars show hypothetical 95% CIs for these differences. Three possible noninferiority margins are shown (M0, M1, M2). For more explanation, see the . Interpretation of equivalence margins in active-control trials.STESETAppendix
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      1. Ann Intern Med September 19, 2000 vol. 133 no. 6 455-463
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