Clinicians need to know the proper conduct, pitfalls and interpretations of drug trials in order to carry out properly their primary duty of treating their individual patients in the most effective manner. In such trials, there must be fully specified goals, subjects, regimens, results and analyses. Randomized, double-blind trials are the primary basis for (a) the proper application of statistical tests and (b) the avoidance of bias; deviations from this ideal leave conclusions in question. The reader should not abrogate his responsibility to interpret for himself the reported results, for which the items above listed are essential. Nonstatisticians can readily employ simple tests such as Chi- square analysis and confidence interval calculation to give estimates of α (false acceptance of differences) and β (false rejection of differences) errors. Statistical significance of a difference is subordinate to biologic significance, and drug trial results – positive or not – can rarely be taken as the sole criterion for action. Especially with small samples, lack of significant differences may be meaningless.

Keywords:
Clinical trials, Treatment protocols, Statistical testing, α and β errors, Confidence intervals
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© 1982 S. Karger AG, Basel
1982
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