title: Power considerations for trials of two experimental arms versus a standard active control or placebo.
abstract: The power of the two-experimental arm trial depends on three choices: (1) when one arm is dropped (if at all); (2) the final testing procedure, assuming no dropping; and (3) the sampling ratio for the three arms. Multiple-arm designs require critical values which were calculated using Mathematica. Power calculations were exact based on probabilities from binomial distributions. The "drop the loser" strategy is optimal for the primary endpoint. The equal sized two treated arm trial gives reasonable power for the primary as well as good power to select the best treated arm. The best power was provided by the 3:3:4 sampling, but it was only marginally better.
authors.affiliation: Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA victor.hasselblad@dm.duke.edu.
authors.forename: Vic
authors.initials: V
authors.lastname: Hasselblad
mesh_terms: D000077284:Abciximab; D000800:Angioplasty, Balloon; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D016010:Binomial Distribution; D018849:Controlled Clinical Trials as Topic / Q000379:methods*; D000077542:Eptifibatide; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use; D010455:Peptides / Q000008:administration & dosage / Q000627:therapeutic use; D010919:Placebos; D011336:Probability; D018401:Sample Size; D015607:Stents
chemical_list: D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010455:Peptides; D010919:Placebos; D000077542:Eptifibatide; D000077284:Abciximab
keywords: adaptive; critical values; multi-arm trial; power