Biomaterial Database

A treatment allocation procedure for sequential clinical trials. 1980

C B Begg, and B Iglewicz

A dynamic treatment allocation procedure is proposed for clinical trials which require balancing across several prognostic factors. The treatment allocation decision is based on the minimization of a function which is an easily evaluated approximation to the variance of the treatment effect in a linear model relating the outcome variable to the chosen prognostic factors and selected interactions. By use of simulations, the procedure is shown to be superior to ad hoc procedures proposed by Pocock and Simon (1975, Biometrics 31, 103-115), over a variety of reasonable experimental situations. It is shown that it is feasible to evaluate the procedure by hand calculations and that it is extremely easy if a small programmable calculator is available. Practical problems relating to implementation of the procedure are discussed with special reference to multi-institutional clinical trials.

UI	MeSH Term	Description	Entries
D011336	Probability	The study of chance processes or the relative frequency characterizing a chance process.	Probabilities
D011379	Prognosis	A prediction of the probable outcome of a disease based on a individual's condition and the usual course of the disease as seen in similar situations.	Prognostic Factor,Prognostic Factors,Factor, Prognostic,Factors, Prognostic,Prognoses
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
D003201	Computers	Programmable electronic devices designed to accept data, perform prescribed mathematical and logical operations at high speed, and display the results of these operations.	Calculators, Programmable,Computer Hardware,Computers, Digital,Hardware, Computer,Calculator, Programmable,Computer,Computer, Digital,Digital Computer,Digital Computers,Programmable Calculator,Programmable Calculators
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man