Suggested statistical reporting guidelines for clinical trials data

Indian J Psychol Med. 2012 Jan;34(1):25-9. doi: 10.4103/0253-7176.96152.

Abstract

Statistical methods are widely accepted tools for analyzing data and drawing appropriate conclusions. However, inappropriate statistical methods may lead to unsuitable or false conclusions. Statistical quality of articles published in Indian medical journals presents with statistical fallacies and very few attempts have been done to document it till date. Issues related to inappropriate use of statistic in interpreting clinical trial raises serious doubt about the validity of the results published and there generalization to patient population. Clinical trials are considered to have one of the highest evidences in terms of efficacy of any intervention and hence results reported in these clinical trials help in appropriate decision making in clinical practices. Present manuscript is an attempt to have an insight into issues related to inappropriate use of statistic during clinical trials and suggests possible methods by which such fallacies can be averted.

Keywords: Statistics; clinical trials; multiple end points; type 1 error.