September 26, 2023

The Lancet has mentioned it’s going to open an investigation right into a trial of the anticlotting drug rivaroxaban, after an investigation by The BMJ into the regulatory oversight of scientific trials by the US Meals and Drug Administration.1

Throughout an inspection audit of the Record4 examine into rivaroxaban,2 the FDA recognized quite a few and critical knowledge integrity deficiencies at eight of the examine’s 16 scientific trial websites. However when the trial was printed within the Lancet in 2009 the investigators made no point out of the info integrity points, and since then the paper has been cited greater than 1100 instances by different researchers unaware of the issues.

All Record4 authors claimed that they’d “full entry to all the knowledge and analyses, and ensure[ed] the accuracy and completeness of the info reported.” However when The BMJ raised the info integrity points with them in October this yr, the examine’s lead creator, Alexander Turpie, emeritus professor of medication at McMaster College, Ontario, mentioned that he was unaware of the FDA violations. Turpie and the Lancet advised The BMJ that they’d examine the matter.

Then, on 9 December 2022, greater than a decade after the Record4 trial was printed, the Lancet printed a correction by Turpie.3 It learn, “On behalf of the Record4 Steering Committee and my coauthors, I remorse and …