Statistical reasoning in clinical trials: Hypothesis testing

Gabor D Kelen, Charles G. Brown, James Ashton

Research output: Contribution to journalArticle

Abstract

Hypothesis testing is based on certain statistical and mathematical principles that allow investigators to evaluate data by making decisions based on the probability or implausibility of observing the results obtained. However, classic hypothesis testing has its limitations, and probabilities mathematically calculated are inextricably linked to sample size. Furthermore, the meaning of the p value frequently is misconstrued as indicating that the findings are also of clinical significance. Finally, hypothesis testing allows for four possible outcomes, two of which are errors that can lead to erroneous adoption of certain hypotheses: 1. 1. The null hypothesis is rejected when, in fact, it is false. 2. 2. The null hypothesis is rejected when, in fact, it is true (type I or α error). 3. 3. The null hypothesis is conceded when, in fact, it is true. 4. 4. The null hypothesis is conceded when, in fact, it is false (type II or β error). The implications of these errors, their relation to sample size, the interpretation of negative trials, and strategies related to the planning of clinical trials will be explored in a future article in this journal.20.

Original languageEnglish (US)
Pages (from-to)52-61
Number of pages10
JournalAmerican Journal of Emergency Medicine
Volume6
Issue number1
DOIs
StatePublished - 1988

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Keywords

  • Clinical trials
  • probability
  • statistical testing
  • t test

ASJC Scopus subject areas

  • Emergency Medicine

Cite this

Statistical reasoning in clinical trials : Hypothesis testing. / Kelen, Gabor D; Brown, Charles G.; Ashton, James.

In: American Journal of Emergency Medicine, Vol. 6, No. 1, 1988, p. 52-61.

Research output: Contribution to journalArticle

Kelen, Gabor D ; Brown, Charles G. ; Ashton, James. / Statistical reasoning in clinical trials : Hypothesis testing. In: American Journal of Emergency Medicine. 1988 ; Vol. 6, No. 1. pp. 52-61.
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