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October 2021

Statistical problems in the reporting of clinical trials. A survey of three medical journals

Author(s): Hughes, M., Lee, R.

Journal/Book: New England Journal of Medicine. 1987; 317: 426-432.

Abstract: Reports of clinical trials often contain a wealth of data comparing treatments. This can lead to problems in interpretation, particularly when significance testing is used extensively. We examined 45 reports of comparative trials published in the British Medical Journal, the Lancet, or the New England Journal of Medicine to illustrate these statistical problems.The issues we considered included the analysis of mul-tiple end points, the analysis of repeated measurements over time, subgroup analyses, trials of multiple treatments, and the overall number of significance tests in a trial re-port. Interpretation of large amounts of data is complicated by the common failure to specify in advance the intended size of a trial or statistical stopping rules for interim analy-ses. In addition, summaries or abstracts of trials tend to emphasize the more statistically significant end points.Overall, the reporting of clinical trials appears to be bi-ased toward an exaggeration of treatment differences. Tri-als should have a clearer predefined policy for data analy-sis and reporting. In particular, a limited number of primary treatment comparisons should be specified in advance. The overuse of arbitrary significance levels (for example, P<0.05) is detrimental to good scientific reporting, and more emphasis should be given to the magnitude of treat-ment differences arid to estimation methods such as confi-dence intervals.

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