Multiple targeted therapies: is there a place for Vach type-3 or type-4 design trials.
Invited comment on Vach W. and dePoint Christensen R. (2006). Making efficient use of patients in designing phase III trials investigating simultaneously a set of targeted therapies with different targets, Biometrical Journal 48, 897-907. For complexity reasons the designs proposed by Vach et al. will probably not be used in initial drug registration trials. But they may be an option for established study groups that run treatment-optimisation or indication-extension trials investigating targeted drugs that are already registered.
Hasenclever
Dirk
D
Institute for Medical Informatics, Statistics & Epidemiology (IMISE), University of Leipzig, Haertelstr. 16-18, 04103 Leipzig, Germany. dirk.hasenclever@imise.uni-leipzig.de
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001699:Biometry / Q000379:methods*; D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D003627:Data Interpretation, Statistical; D016503:Drug Delivery Systems / Q000379:methods* / Q000706:statistics & numerical data*; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy* / Q000453:epidemiology; D018579:Patient Selection; D012107:Research Design
D000970:Antineoplastic Agents