title: Statistical issues in clinical trial design.
abstract: This paper reviews some of the more salient recent developments in statistical aspects of clinical trial design methodology and suggests that more emphasis be placed on rigorous assessments of the new methodologies to place them in the context of existing methods, demonstrate their claimed advantages, and fully disclose their remaining limitations.
authors.affiliation: Department of Biostatistics and Applied Mathematics, The University of Texas M.D. Anderson Cancer Center , 1515 Holcombe Boulevard, Unit 447, Houston, TX 77030-4009, USA. khess@mdanderson.org
authors.forename: Kenneth R
authors.initials: KR
authors.lastname: Hess
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D015233:Models, Statistical; D012107:Research Design