- Almost half of meta-analyses of apixaban include falsified data from the ARISTOTLE trials.
- In a third, the inclusion yields a “considerable change” in outcome.
Why this matters
- The ARISTOTLE clinical trial data were falsified in some cases, yet the published results have been included in several meta-analyses that are used for patient care and policy decisions, say the authors.
- The falsified data in ARISTOTLE were submitted from a clinical site in China; according to an analysis, without these data, the significant mortality benefit vanishes, yet was still reported in related literature.
- The authors identified data from ARISTOTLE in 22 meta-analyses, published 2012-2017.
- 46% would have had different findings with omission of ARISTOTLE data.
- 32% of estimates of apixaban effect would change:
- 97% of these would no longer favor apixaban.
- 3% would favor control.
- Subgroup analyses also were affected: 44% would have different conclusions with omission of ARISTOTLE data.
- The ARISTOTLE trial evaluated apixaban, and in a review of publications with falsified data, ARISTOTLE had the most.
- These authors followed Cochrane rules for systematic review to assess meta-analyses that included data from at least 1 ARISTOTLE publication.
- Funding: Federal Employee Education and Assistance Fund/National Treasury Employee Union; NIH.
- The limitations related to the included meta-analyses.