Biomaterial Database

Power considerations for clinical trials using multivariate time-to-event data. 1997

M D Hughes

Department of Biostatistics, Harvard School of Public Health, Boston, MA 02115, USA.

Many clinical trials involve the collection of data on the times to occurrence of different types of events, such as different fungal infections in AIDS research, or of recurrences of the same type, such as successive fits in epilepsy research. The multivariate proportional hazards model allows for analysis of this data and software for doing this is now widely available. In this paper, the approximate power of a clinical trial that aims to use such data for comparing two treatments is derived. Special attention is given to the bivariate case, both to show that the approximation works well and to illustrate how various design parameters affect the power of a trial. As with any multivariate data in clinical trials, there are many conceptual issues that should be considered during trial design; the paper closes with a discussion of some of these.

UI	MeSH Term	Description	Entries
D009181	Mycoses	Diseases caused by FUNGI.	Fungus Diseases,Fungal Diseases,Fungal Infections,Fungus Infections,Disease, Fungal,Disease, Fungus,Diseases, Fungal,Diseases, Fungus,Fungal Disease,Fungal Infection,Fungus Disease,Fungus Infection,Infection, Fungal,Infection, Fungus,Infections, Fungal,Infections, Fungus
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
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012494	Sampling Studies	Studies in which a number of subjects are selected from all subjects in a defined population. Conclusions based on sample results may be attributed only to the population sampled.	Probability Sample,Probability Samples,Sample, Probability,Samples, Probability,Sampling Study,Studies, Sampling,Study, Sampling
D013997	Time Factors	Elements of limited time intervals, contributing to particular results or situations.	Time Series,Factor, Time,Time Factor
D015233	Models, Statistical	Statistical formulations or analyses which, when applied to data and found to fit the data, are then used to verify the assumptions and parameters used in the analysis. Examples of statistical models are the linear model, binomial model, polynomial model, two-parameter model, etc.	Probabilistic Models,Statistical Models,Two-Parameter Models,Model, Statistical,Models, Binomial,Models, Polynomial,Statistical Model,Binomial Model,Binomial Models,Model, Binomial,Model, Polynomial,Model, Probabilistic,Model, Two-Parameter,Models, Probabilistic,Models, Two-Parameter,Polynomial Model,Polynomial Models,Probabilistic Model,Two Parameter Models,Two-Parameter Model
D015497	HIV-1	The type species of LENTIVIRUS and the etiologic agent of AIDS. It is characterized by its cytopathic effect and affinity for the T4-lymphocyte.	Human immunodeficiency virus 1,HIV-I,Human Immunodeficiency Virus Type 1,Immunodeficiency Virus Type 1, Human
D015999	Multivariate Analysis	A set of techniques used when variation in several variables are studied simultaneously. In statistics, multivariate analysis is interpreted as any analytic method that allows simultaneous study of two or more dependent variables.	Analysis, Multivariate,Multivariate Analyses
D016016	Proportional Hazards Models	Statistical models used in survival analysis that assert that the effect of the study factors on the hazard rate in the study population is multiplicative and does not change over time.	Cox Model,Cox Proportional Hazards Model,Hazard Model,Hazards Model,Hazards Models,Models, Proportional Hazards,Proportional Hazard Model,Proportional Hazards Model,Cox Models,Cox Proportional Hazards Models,Hazard Models,Proportional Hazard Models,Hazard Model, Proportional,Hazard Models, Proportional,Hazards Model, Proportional,Hazards Models, Proportional,Model, Cox,Model, Hazard,Model, Hazards,Model, Proportional Hazard,Model, Proportional Hazards,Models, Cox,Models, Hazard,Models, Hazards,Models, Proportional Hazard