FDA Advice On Missing Data May Be To Avoid Missing It In The First Place
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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.
You may also be interested in...
FDA Panel To Take Second Look After J&J Plugged Holes In Xarelto ATLAS Data
Broader issue of missing data in clinical trials could see further discussion as FDA’s Cardiovascular and Renal Advisory Committee will relook at Xarelto’s acute coronary syndrome indication Jan. 16, now that J&J has tried to address the missing data that befuddled the committee on the first go-round.
Clinical Trial Dropouts, Missing Data Get FDA Attention At GSK Anoro Ellipta Review
More than a year after hints of forthcoming guidance on missing data, agency looks toward future where sponsors do more to retain patients and follow up on those that leave clinical trials.
FDA Panel Looks Beyond Xarelto’s Missing Data Problems To Broader Reforms
Despite the agency’s decision to limit discussion about missing data to the ATLAS pivotal trial of rivaroxaban, Cardio-Renal advisory committee members suggested reforms that sponsors should consider to prevent the kinds of problems seen in ATLAS.