title: Three methods for constructing parallel gatekeeping procedures in clinical trials.
abstract: This paper gives a review of three classes of parallel gatekeeping procedures that can be used in clinical trials with multiple objectives grouped into two or more families. We begin with a high-level summary of three methods for building parallel gatekeeping procedures proposed in the literature and provide a detailed comparison of the three methods. The comparison is based on analytical arguments as well as simulation studies and helps us develop general recommendations on the use of these methods in clinical trial applications. The methods discussed in this paper are illustrated using clinical trial examples with two families of objectives.
authors.affiliation: Eli Lilly and Company, Indianapolis, Indiana 46285, USA, USA. dmitrienko_alex@lilly.com
authors.forename: Alex
authors.initials: A
authors.lastname: Dmitrienko
authors.forename: Julia N
authors.initials: JN
authors.lastname: Soulakova
authors.forename: Brian A
authors.initials: BA
authors.lastname: Millen
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003198:Computer Simulation; D003627:Data Interpretation, Statistical; D023381:Endpoint Determination; D015233:Models, Statistical; D009010:Monte Carlo Method; D017063:Outcome Assessment, Health Care / Q000379:methods*