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.
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FDA’s Center for Drug Evaluation and Research plans to publish more than 50 new and revised draft guidances this calendar year.
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.
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.