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 | Research, Methods, Statistics | JAMA Internal Medicine | JAMA Network
[Skip to Navigation]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address 35.170.64.36. Please contact the publisher to request reinstatement.
1.
Garmendia  CA, Bhansali  N, Madhivanan  P.  Research misconduct in FDA-regulated clinical trials: a cross-sectional analysis of warning letters and disqualification proceedings.   Ther Innov Regul Sci. 2018;52(5):592-605.PubMedGoogle ScholarCrossref
2.
Seife  C.  Research misconduct identified by the US Food and Drug Administration: out of sight, out of mind, out of the peer-reviewed literature.   JAMA Intern Med. 2015;175(4):567-577. doi:10.1001/jamainternmed.2014.7774PubMedGoogle ScholarCrossref
3.
Slavin  RE.  Best evidence synthesis: an intelligent alternative to meta-analysis.   J Clin Epidemiol. 1995;48(1):9-18. doi:10.1016/0895-4356(94)00097-APubMedGoogle ScholarCrossref
4.
The Cochrane Collaboration. Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0). https://training.cochrane.org/handbook. Accessed September 5, 2018.
5.
Office of Research Integrity, US Department of Health and Human Services. Definition of Research Misconduct (April 25, 2011). https://ori.hhs.gov/definition-misconduct. Accessed September 5, 2018.
Limit 200 characters
Limit 25 characters
Conflicts of Interest Disclosure

Identify all potential conflicts of interest that might be relevant to your comment.

Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.

Err on the side of full disclosure.

If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.

Not all submitted comments are published. Please see our commenting policy for details.

Limit 140 characters
Limit 3600 characters or approximately 600 words
    Research Letter
    March 4, 2019

    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

    Author Affiliations
    • 1Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs, US Food and Drug Administration, Miami, Florida
    • 2Department of Epidemiology, Robert Stempel College of Public Health and Social Work, Florida International University, Miami
    • 3Department of Psychology, School of Integrated Science and Humanity, Florida International University, Miami
    • 4Department of Biostatistics, Robert Stempel College of Public Health and Social Work, Florida International University, Miami
    JAMA Intern Med. 2019;179(4):582-583. doi:10.1001/jamainternmed.2018.7661

    Clinical trials under the purview of the US Food and Drug Administration (FDA) have been shown to report falsified data.1 The FDA warns researchers when falsified data are discovered, but these data have made it into the medical literature.1,2 The desire to include all available data in a meta-analysis to obtain the “best estimate” of effect size may result in the inclusion of falsified data, which may compromise future research, policy decisions, and patient care.3 The present study evaluates the inclusion of studies with falsified data in meta-analyses.

    As identified by Seife,2 the ARISTOTLE clinical trial, which studied the pharmaceutical agent apixaban, had the most publications containing falsified data. Therefore, we conducted a systematic review, per the Cochran Handbook for Systematic Reviews of Interventions (PROSPERO Identifier: CRD42017055627),4 to identify meta-analyses that contained at least 1 ARISTOTLE clinical trial publication with falsified data. The institutional review board of Florida International University determined that board approval was not required because the study involved no human participants.

    ×