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

FDA officials respond to the recommendations of a National Research Council Panel on handling missing data in clinical trials, giving early indications of how FDA could be viewing a forthcoming guidance on the issue.

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...