Missing Data May Skew Clinical Trials

HealthDay News: By Serena Gordon WEDNESDAY, Oct. 3, 2012

Data missing from clinical trials can undermine the credibility of those trials, and little attention has been focused on this issue until recently, experts say.

Even regulatory guidelines that direct how clinical trials should be run offer little advice on dealing with missing information, according to a new report from an expert panel commissioned by the National Research Council.

And, while statisticians may be able to control for the missing data, they can end up making “assumptions about what the outcomes would’ve been, and when you’re doing a phase 3 clinical trial [that could lead to a drug’s regulatory approval or denial], people don’t want to make assumptions. They want to assure balance, which argues for trying to limit the amount of missing data,” said the panel chairman, Rod Little, a biostatistics professor at the University of Michigan School of Public Health in Ann Arbor. Read more