Cardiovascular Outcomes Trials Increasingly Complicated By Missing Data
Executive SummaryAs regulators and payers alike look for sponsors to conduct large-scale cardiovascular outcomes trials in a variety of settings, the problem posed by missing data is a slippery slope, as recent FDA advisory committee reviews of Brilinta and Avandia showcase
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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 will ask its cardio-renal advisory committee whether missing data in J&J/Bayer’s ATLAS study affects the interpretability of rivaroxaban’s demonstrated efficacy in acute coronary syndromes. The panel also will be asked whether the agency should pre-specify clinical trial standards for data quality to reduce the problems associated with missing data in CV outcomes studies.