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FDA Panel Looks Beyond Xarelto’s Missing Data Problems To Broader Reforms

 
• By Sue Sutter

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 advisory committee members weighing use of Johnson & Johnson/Bayer HealthCare AG’s Xarelto (rivaroxaban) for acute coronary syndromes took the opportunity to look beyond the sNDA, and the problems resulting from missing data in the ATLAS pivotal study, to consider how best to prevent clinical study participants and their outcomes from going missing in the first place.

Reforms suggested by Cardiovascular and Renal Drugs Advisory Committee members included bolstering consent procedures so that participants can make better informed decisions about whether to withdraw from a study and...

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