FDA Advice On Missing Data May Be To Avoid Missing It In The First Place

Coming guidance from FDA on handling missing data in clinical trials will likely urge sponsors to adopt new approaches to prevent the problem, in addition to providing advice on determining the best statistical methods for dealing with the missing data when analyzing the trial.

In an article in the March issue of Nature Clinical Pharmacology and Therapeutics, former FDA Office of Biostatistics Director Robert O’Neill, who retired in July 2011 after 40 years with...