Rivaroxaban: Lancet opens investigation into anticlotting drug trial after BMJ reportBMJ 2022; 379 doi: https://doi.org/10.1136/bmj.o3071 (Published 30 December 2022) Cite this as: BMJ 2022;379:o3071
- Maryanne Demasi
The Lancet has said it will open an investigation into a trial of the anticlotting drug rivaroxaban, after an investigation by The BMJ into the regulatory oversight of clinical trials by the US Food and Drug Administration.1
During an inspection audit of the Record4 study into rivaroxaban,2 the FDA identified numerous and serious data integrity deficiencies at eight of the study’s 16 clinical trial sites. But when the trial was published in the Lancet in 2009 the investigators made no mention of the data integrity issues, and since then the paper has been cited more than 1100 times by other researchers unaware of the problems.
All Record4 authors claimed that they had “full access to all of the data and analyses, and confirm[ed] the accuracy and completeness of the data reported.” But when The BMJ raised the data integrity issues with them in October this year, the study’s lead author, Alexander Turpie, emeritus professor of medicine at McMaster University, Ontario, said that he was unaware of the FDA violations. Turpie and the Lancet told The BMJ that they would investigate the matter.
Then, on 9 December 2022, more than a decade after the Record4 trial was published, the Lancet published a correction by Turpie.3 It read, “On behalf of the Record4 Steering Committee and my coauthors, I regret and …