Written by Clay Smith
Removal of the ARISTOTLE study (known to contain falsified data) from 22 subsequent meta-analyses led to a change in the conclusion of these meta-analyses nearly half the time. Research misconduct hurts people.
Why does this matter?
Meta-analyses are only as good as the studies they contain. Integrity and truth in research is a life and death matter, because clinicians put results of studies into practice. The FDA investigates the conduct of trials at times, and occasionally finds information that is quite concerning (you may want to click this link). However, this may or may not become public. The ARISTOTLE trial, using apixaban for treatment of a-fib, was published even though it was known that part of the dataset was falsified.
Lies, damned lies, and meta-analyses
The faulty ARISTOTLE trial, mentioned above, has been cited in 22 meta-analyses. Once the ARISTOTLE study, which has been shown to contain falsified data, was removed from these 22 meta-analyses, 10 of them (46%), “had conclusions altered by publications with falsified data, and 32% of all the analyses had a considerable change in the outcome.” Generally speaking, research is conducted ethically. But it’s bad news when it’s not. The original study may lead to an erroneous change in practice, and subsequent incorporation into meta-analyses may lead to a compounding of the negative impact. This is a call for integrity. When research misconduct happens, people get hurt.
Evaluation of the Inclusion of Studies Identified by the FDA as Having Falsified Data in the Results of Meta-analyses: The Example of the Apixaban Trials. JAMA Intern Med. 2019 Mar 4. doi: 10.1001/jamainternmed.2018.7661. [Epub ahead of print]
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Reviewed by Thomas Davis