title: Crossover versus parallel designs: dose-escalation design comparisons for first-in-human studies.
abstract: We study the statistical efficiency for rising-dose designs in the context of first-in-human studies. Specifically, we identify a class of crossover designs that are appealing in terms of both subject safety and statistical efficiency and, for a three-period, two-panel design in such a class, we compare its A-efficiency relative to the corresponding parallel designs and optimal/efficient crossover designs, respectively, under various plausible models. In the meantime, we also evaluate the impact of inclusion of baseline measurements as a covariate in the statistical analysis, for both crossover and parallel studies.
authors.affiliation: Allergan, Inc., Irvine, CA 92612, USA. yan_zhiwu@allergan.com
authors.forename: Zhiwu
authors.initials: Z
authors.lastname: Yan
authors.forename: Balakrishna
authors.initials: B
authors.lastname: Hosmane
authors.forename: Charles
authors.initials: C
authors.lastname: Locke
mesh_terms: D017321:Clinical Trials, Phase I as Topic / Q000379:methods / Q000706:statistics & numerical data; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D006801:Humans; D015233:Models, Statistical; D012107:Research Design / Q000706:statistics & numerical data*; D016896:Treatment Outcome