FDA Advice On Missing Data May Be To Avoid Missing It In The First Place
This article was originally published in Pharmaceutical Approvals Monthly
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.
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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.
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.
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.