Exact tests for epidemiological risks under independent negative binomial sampling for rare events in clinical trials

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Abstract

2 × 2 contingency tables are frequently obtained from independent binomial sampling. However, when the probabilities of the outcome of interest are small, we may use independent negative binomial sampling in which sampling stops after a predetermined number of the outcome of interest occurs. The obtained 2 × 2 contingency tables are likely to be unbalanced, and the asymptotic tests could be unreliable. In this article, we develop exact conditional tests for the risk difference, the risk ratio, and the odds ratio in 2 × 2 contingency tables obtained from independent negative binomial sampling. We investigate the exact unconditional powers of the exact tests. The main advantage of exact test is that it is guaranteed to control type I errors under the nominal level unconditionally.

Original languageEnglish
Pages (from-to)115-121
Number of pages7
JournalDrug Information Journal
Volume42
Issue number2
DOIs
Publication statusPublished - 2008 Jan 1

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Odds Ratio
Clinical Trials
Sampling

All Science Journal Classification (ASJC) codes

  • Pharmacology (nursing)
  • Drug guides
  • Public Health, Environmental and Occupational Health
  • Pharmacology (medical)

Cite this

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abstract = "2 × 2 contingency tables are frequently obtained from independent binomial sampling. However, when the probabilities of the outcome of interest are small, we may use independent negative binomial sampling in which sampling stops after a predetermined number of the outcome of interest occurs. The obtained 2 × 2 contingency tables are likely to be unbalanced, and the asymptotic tests could be unreliable. In this article, we develop exact conditional tests for the risk difference, the risk ratio, and the odds ratio in 2 × 2 contingency tables obtained from independent negative binomial sampling. We investigate the exact unconditional powers of the exact tests. The main advantage of exact test is that it is guaranteed to control type I errors under the nominal level unconditionally.",
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