Biomaterial Database

Optimal flexible designs in phase II clinical trials. 1998

T T Chen, and T H Ng

Biometric Research Branch, National Cancer Institute, Bethesda, Maryland 20892, USA. tchen@helix.nih.gov

In the conduct of a phase II cancer clinical trial, patients usually enter in two stages. If the response rate from the first stage is low, then the study terminates. Within various two-stage designs, Simon proposed the optimal and minimax criteria. In the co-operative group setting, practical considerations make it difficult to arrive at the planned sample size exactly. Green and Dahlberg proposed and compared several flexible designs. In this paper, we explicitly define a flexible design as a collection of two-stage designs where the first stage size is in a set of consecutive values (n1, ..., nk) and the second stage size is also in another set of consecutive values (N1, ..., Nk), and each of k2 possible designs has the same probability of occurrence. We apply Simon's optimal and minimax criteria to flexible designs for phase II trials in order to minimize the number of patients tested on an ineffective drug.

UI	MeSH Term	Description	Entries
D012107	Research Design	A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly.	Experimental Design,Data Adjustment,Data Reporting,Design, Experimental,Designs, Experimental,Error Sources,Experimental Designs,Matched Groups,Methodology, Research,Problem Formulation,Research Methodology,Research Proposal,Research Strategy,Research Technics,Research Techniques,Scoring Methods,Adjustment, Data,Adjustments, Data,Data Adjustments,Design, Research,Designs, Research,Error Source,Formulation, Problem,Formulations, Problem,Group, Matched,Groups, Matched,Matched Group,Method, Scoring,Methods, Scoring,Problem Formulations,Proposal, Research,Proposals, Research,Reporting, Data,Research Designs,Research Proposals,Research Strategies,Research Technic,Research Technique,Scoring Method,Source, Error,Sources, Error,Strategies, Research,Strategy, Research,Technic, Research,Technics, Research,Technique, Research,Techniques, Research
D013223	Statistics as Topic	Works about the science and art of collecting, summarizing, and analyzing data that are subject to random variation.	Area Analysis,Estimation Technics,Estimation Techniques,Indirect Estimation Technics,Indirect Estimation Techniques,Multiple Classification Analysis,Service Statistics,Statistical Study,Statistics, Service,Tables and Charts as Topic,Analyses, Area,Analyses, Multiple Classification,Area Analyses,Classification Analyses, Multiple,Classification Analysis, Multiple,Estimation Technic, Indirect,Estimation Technics, Indirect,Estimation Technique,Estimation Technique, Indirect,Estimation Techniques, Indirect,Indirect Estimation Technic,Indirect Estimation Technique,Multiple Classification Analyses,Statistical Studies,Studies, Statistical,Study, Statistical,Technic, Indirect Estimation,Technics, Estimation,Technics, Indirect Estimation,Technique, Estimation,Technique, Indirect Estimation,Techniques, Estimation,Techniques, Indirect Estimation
D017322	Clinical Trials, Phase II as Topic	Works about studies that are usually controlled to assess the effectiveness and dosage (if appropriate) of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques. These studies are performed on several hundred volunteers, including a limited number of patients with the target disease or disorder, and last about two years. This concept includes phase II studies conducted in both the U.S. and in other countries.	Drug Evaluation, FDA Phase 2 as Topic,Drug Evaluation, FDA Phase II as Topic,Evaluation Studies, FDA Phase 2 as Topic,Evaluation Studies, FDA Phase II as Topic