Statistical shortcomings in licensing applications

J A Lewis, K M Facey

Research output: Contribution to journalReview articlepeer-review

Abstract

This paper concerns the statistical work carried out with respect to clinical trials conducted for regulatory purposes. Although the general quality of such work has improved markedly over recent years and is now generally high, a number of shortcomings remain. A few of these arise from failure to follow well established statistical practice. Rather more arise from a poor understanding of areas of known statistical disagreement and from the unsatisfactory use of newer and more advanced techniques. Inadequacies in reporting statistical work are commonplace. Examples of all these shortcomings are provided and emphasis is placed on the value of a statistical contribution to overall summaries such as the clinical expert report.

Original languageEnglish
Pages (from-to)1663-73
Number of pages11
JournalSTATISTICS IN MEDICINE
Volume17
Issue number15-16
DOIs
Publication statusPublished - 28 Sep 1998

Keywords

  • Clinical Trials, Phase II as Topic/standards
  • Clinical Trials, Phase III as Topic/standards
  • Data Interpretation, Statistical
  • Dose-Response Relationship, Drug
  • Drug Approval
  • Europe
  • Guidelines as Topic
  • Humans
  • Licensure
  • Meta-Analysis as Topic
  • Regression Analysis
  • Reproducibility of Results
  • Research Design/standards

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