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.
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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.
FDA could have concerns about the reported data from the ARISTOTLE trial, either from the bleeding comparisons or the dosing in the warfarin control arm. Missing data is another possible issue, as in the recent “complete response” letter for J&J/Bayer’s Xarelto.