Reporting Clinical Trial Results

Hayward RA, Kent DM, Vijan S, Hofer TP. Reporting clinical trial results to inform providers, payers, and consumers. Health Affairs (Millwood). 2005 Nov-Dec;24(6):1571-81.

This article gives a candid account of how the "the conventional approach to reporting clinical trials has fundamental flaws that can result in overlooking identifiable subgroups harmed by a treatment while underestimating benefits to others."

The reporting of some clinical studies can be biased in a number of ways: the perception of the researchers; and professional, political, and financial incentives. This report discusses the bias of "the desire to promote a beneficial treatment for use in as many people as possible".

The authors recommend that the evidence reported in the study can be greatly enhanced by ensuring that "whenever a multivariable prediction tool is available, the observed relative and absolute risk reduction for subjects with higher versus lower predicted net benefit should be reported using risk-stratified analysis.

This discussion is a reminder that all research that reports clinical trials should be carefully analyzed for accuracy.