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Publications from multicentre clinical trials: statistical techniques and accessibility to the reader

M J Marsh1, B S Hawkins

  • 1Johns Hopkins University, Wilmer Ophthalmological Institute, Baltimore, Maryland 21205.

Statistics in Medicine
|December 15, 1994
PubMed
Summary

Clinical trial publications require advanced statistical knowledge beyond basic methods. Understanding treatment comparisons in clinical trials necessitates familiarity with a wider range of statistical techniques.

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Area of Science:

  • Biostatistics
  • Clinical Trials Methodology
  • Medical Research

Background:

  • Assessing statistical method usage in multicentre randomized clinical trials.
  • Comparing statistical practices between clinical trial investigators and other medical researchers.
  • Evaluating the statistical knowledge required to interpret clinical trial data.

Purpose of the Study:

  • To compare the frequency of statistical method usage in clinical trials versus other medical research.
  • To determine the level of statistical expertise needed to comprehend clinical trial publications.

Main Methods:

  • Analysis of articles from multicentre randomized clinical trials.
  • Adaptation of statistical analysis methods (Emerson and Colditz, Juzych et al.).
  • Comparison of statistical method frequency and publication accessibility.

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Main Results:

  • Observed differences in statistical method usage between clinical trial publications and general medical research articles.
  • Clinical trial publications are less accessible to readers with only basic statistical knowledge (descriptive statistics, t-tests, etc.).
  • A broader statistical knowledge base is required for full comprehension of clinical trial treatment group comparisons.

Conclusions:

  • Readers need advanced statistical knowledge to fully understand clinical trial results.
  • The complexity of statistical methods in clinical trials impacts accessibility for a broader medical audience.
  • Further research may explore methods to improve the accessibility of clinical trial findings.