title: One-sample proportion testing procedures for hypothesis of inequality.
abstract: The primary objective of a phase II single arm clinical trial is to determine whether a new treatment is of sufficient activity for a disease to warrant further development. This paper presents single arm one-stage and two-stage designs for testing the response rate of a test treatment against the response rate of an existing treatment. The null and alternative hypotheses are the response rate of the test treatment is equal and unequal to that of the existing treatment respectively. The testing procedures are calculated with exact binomial distribution. Two-stage designs presented minimize total sample size and satisfy type I and II error constraints, with flexibility in the fraction of the total sample size to use in the first stage.
authors.affiliation: Octagon Research Solutions, Inc., Wayne, PA, USA.
authors.forename: Wayne
authors.initials: W
authors.lastname: Zhong
authors.forename: Bob
authors.initials: B
authors.lastname: Zhong
mesh_terms: D000486:Allergy and Immunology; D017322:Clinical Trials, Phase II as Topic / Q000379:methods* / Q000706:statistics & numerical data*; D017326:Clinical Trials, Phase III as Topic / Q000379:methods / Q000706:statistics & numerical data; D004358:Drug Therapy; D006801:Humans; D012107:Research Design; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration