Cardiovascular Outcomes Trials Increasingly Complicated By Missing Data
As 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.
A new National Academy of Sciences' report on missing clinical trial data is expected to lead to significant changes in how industry sponsors design and conduct studies and statistically account for the effects of drop-outs