title: Sequential monitoring of randomization tests: stratified randomization.
abstract: In many clinical trials, it is desirable to establish a sequential monitoring plan, whereby the test statistic is computed at an interim point or points in the trial and a decision is made whether to stop early due to evidence of treatment efficacy. In this article, we will set up a sequential monitoring plan for randomization-based inference under the permuted block design, stratified block design, and stratified urn design. We will also propose a definition of information fraction in these settings and discuss its calculation under these different designs.
authors.affiliation: Merck & Co., Ry34-A316, P.O. Box 2000, Rahway, New Jersey 07065-0900, USA. yanqiong_zhang@merck.com
authors.forename: Yanqiong
authors.initials: Y
authors.lastname: Zhang
authors.forename: William F
authors.initials: WF
authors.lastname: Rosenberger
authors.forename: Robert T
authors.initials: RT
authors.lastname: Smythe
mesh_terms: D001699:Biometry / Q000379:methods*; D003627:Data Interpretation, Statistical; D020000:Decision Support Systems, Clinical; D017063:Outcome Assessment, Health Care / Q000379:methods*; D016016:Proportional Hazards Models; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors