title: Development of gatekeeping strategies in confirmatory clinical trials.
abstract: This paper discusses multiplicity issues arising in confirmatory clinical trials with hierarchically ordered multiple objectives. In order to protect the overall type I error rate, multiple objectives are analyzed using multiple testing procedures. When the objectives are ordered and grouped in multiple families (e.g. families of primary and secondary endpoints), gatekeeping procedures are employed to account for this hierarchical structure. We discuss considerations arising in the process of building gatekeeping procedures, including proper use of relevant trial-specific information and criteria for selecting gatekeeping procedures. The methods and principles discussed in this paper are illustrated using a clinical trial in patients with type II diabetes mellitus.
authors: Eli Lilly and Company, Indianapolis, IN 46285, USA. alexei@lilly.com
authors: Alex
authors: A
authors: Dmitrienko
authors: Brian A
authors: BA
authors: Millen
authors: Thomas
authors: T
authors: Brechenmacher
authors: Gautier
authors: G
authors: Paux
mesh_terms: D001699:Biometry; D002986:Clinical Trials as Topic / Q000379:methods*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D006040:Goals; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D007004:Hypoglycemic Agents