Reporting on Methods in Clinical Trials

Authors:
  • RDRebecca DerSimonian
    Rebecca DerSimonian
  • LCL.Joseph Charette
    L.Joseph Charette
  • BMBucknam McPeek
    Bucknam McPeek
  • FMFrederick Mosteller
    Frederick Mosteller

Abstract
A clinical trial cannot be adequately interpreted without information about the methods used in the design of the study and the analysis of the results. To determine the frequency of reporting what we consider 11 important aspects of design and analysis, we surveyed all 67 clinical trials published in the New England Journal of Medicine, the Lancet, and the British Medical Journal from July through December 1979 and in the Journal of the American Medical Association from July 1979 through June 1980. Of all 11 items in the 67 trials published in all four journals, 56 per cent were clearly reported, 10 per cent were ambiguously mentioned, and 34 per cent were not reported at all.