Biomaterial Database

Optimal two-stage designs for clinical trials with binary response. 1988

P F Thall, and R Simon, and S S Ellenberg, and R Shrager

Statistics/Computer & Information Systems Department, George Washington University, Washington, D.C. 20052.

We present a simple two-stage design for a randomized clinical trial with dichotomous outcomes. It is based on a design of Ellenberg and Eisenberger which permits early acceptance of the null hypothesis after the first stage. We have optimized the design by minimizing the average expected sample size subject to constraints on the type 1 and type 2 errors. The resulting designs have maximum sample size only slightly larger than that of single stage trial, with 40-45 per cent of this maximum allocated to the first stage, and null hypothesis probability of early acceptance in excess of 0.60.

UI	MeSH Term	Description	Entries
D008432	Mathematical Computing	Computer-assisted interpretation and analysis of various mathematical functions related to a particular problem.	Statistical Computing,Computing, Statistical,Mathematic Computing,Statistical Programs, Computer Based,Computing, Mathematic,Computing, Mathematical,Computings, Mathematic,Computings, Mathematical,Computings, Statistical,Mathematic Computings,Mathematical Computings,Statistical Computings
D011336	Probability	The study of chance processes or the relative frequency characterizing a chance process.	Probabilities
D011897	Random Allocation	A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects.	Randomization,Allocation, Random
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
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic