title: Improving Probabilities of Correct Interim Decision in Population Enrichment Designs.
abstract: Choice of target population is an essential part at the design stage of clinical trials. Data from earlier clinical development might suggest that the treatment is more effective in a subpopulation, but there might not be enough evidence to restrict the target population upfront. Adaptive designs allow modification of the target population based on interim data. Decision for modification should be based on objective decision rules. The presented decision rules maximize the weighted probability of correct interim decisions based on prior assumptions. Evaluation of decision rules in the planning phase can improve probabilities of correct interim decision and power.
authors.affiliation: a Global Biostatistics, Merck KGaA , Darmstadt , Germany.
authors.forename: Heiko
authors.initials: H
authors.lastname: Götte
authors.forename: Margarita
authors.initials: M
authors.lastname: Donica
authors.forename: Giacomo
authors.initials: G
authors.lastname: Mordenti
mesh_terms: D015415:Biomarkers / Q000032:analysis; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003198:Computer Simulation; D003627:Data Interpretation, Statistical; D003662:Decision Theory; D006801:Humans; D016014:Linear Models; D009716:Numerical Analysis, Computer-Assisted; D018579:Patient Selection; D011336:Probability; D012107:Research Design / Q000706:statistics & numerical data*; D018401:Sample Size; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers
keywords: Adaptive design; Decision rule; Subpopulation