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PubMed · 10949777

Therapeutic studies.

L V Rubinstein
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Abstract

This article discusses the problems in basic design, conduct, and interpretation associated with phases I, II, and III of the cancer clinical trials and explains the various statistical solutions to these problems. The fundamental problem common to all three trials is achieving a correct and precise answer to the question posed to inform future testing and treatment while protecting trial patients from receiving treatment that has demonstrated excessive toxicity or lack of clinical efficacy. This shared problem gives rise to statistical designs with basic similarities across the three trial types.

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Antineoplastic AgentsArea Under CurveBayes TheoremBiomarkersClinical Trials as TopicClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicControlled Clinical Trials as TopicDose-Response Relationship, DrugEndpoint DeterminationForecastingGuidelines as TopicHumansInformation ServicesLogistic ModelsMulticenter Studies as TopicNeoplasmsProspective StudiesRandom AllocationRandomized Controlled Trials as TopicResearch DesignStochastic ProcessesTreatment OutcomeUnited StatesJournal ArticleReview

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L V Rubinstein. 2000. Therapeutic studies.. https://doi.org/10.1016/s0889-8588(05)70315-4

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