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

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...