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

doi:10.1001/jamainternmed.2018.7661

Review

. 2019 Apr 1;179(4):582-584.

doi: 10.1001/jamainternmed.2018.7661.

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

Craig A Garmendia¹, Liliana Nassar Gorra², Ana Lucia Rodriguez³, Mary Jo Trepka², Emir Veledar⁴, Purnima Madhivanan²

Affiliations

¹ Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs, US Food and Drug Administration, Miami, Florida.
² Department of Epidemiology, Robert Stempel College of Public Health and Social Work, Florida International University, Miami.
³ Department of Psychology, School of Integrated Science and Humanity, Florida International University, Miami.
⁴ Department of Biostatistics, Robert Stempel College of Public Health and Social Work, Florida International University, Miami.

PMID: 30830216
PMCID: PMC6450302
DOI: 10.1001/jamainternmed.2018.7661

Review

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

Craig A Garmendia et al. JAMA Intern Med. 2019.

. 2019 Apr 1;179(4):582-584.

doi: 10.1001/jamainternmed.2018.7661.

Authors

Craig A Garmendia¹, Liliana Nassar Gorra², Ana Lucia Rodriguez³, Mary Jo Trepka², Emir Veledar⁴, Purnima Madhivanan²

Affiliations

¹ Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs, US Food and Drug Administration, Miami, Florida.
² Department of Epidemiology, Robert Stempel College of Public Health and Social Work, Florida International University, Miami.
³ Department of Psychology, School of Integrated Science and Humanity, Florida International University, Miami.
⁴ Department of Biostatistics, Robert Stempel College of Public Health and Social Work, Florida International University, Miami.

PMID: 30830216
PMCID: PMC6450302
DOI: 10.1001/jamainternmed.2018.7661

Erratum in

Coding Errors in Study of Meta-analyses With Falsified Data in the Results.
[No authors listed] [No authors listed] JAMA Intern Med. 2021 Mar 1;181(3):409. doi: 10.1001/jamainternmed.2020.7217. JAMA Intern Med. 2021. PMID: 33226403 Free PMC article. No abstract available.

Abstract

This study evaluates the inclusion of studies identified by the FDA as having falsified data in the results of meta-analyses.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Garmendia reported grants from Federal Employee Education and Assistance Fund/National Treasury Employee Union during the conduct of the study. Ms Rodriguez reported funding from a predoctoral training program by The Fogarty Institute (Global Health Equity Scholars Program) National Institutes of Health (NIH) FIC D43TW010540. No other disclosures were reported.

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Comment in

Correcting Meta-analyses and Reviews Affected by Retracted Research.
Grey A, Avenell A, Bolland M. Grey A, et al. JAMA Intern Med. 2019 Jul 1;179(7):1005. doi: 10.1001/jamainternmed.2019.1875. JAMA Intern Med. 2019. PMID: 31260017 No abstract available.
Correcting Meta-analyses and Reviews Affected by Retracted Research-Reply.
Garmendia CA, Madhivanan P. Garmendia CA, et al. JAMA Intern Med. 2019 Jul 1;179(7):1006. doi: 10.1001/jamainternmed.2019.1870. JAMA Intern Med. 2019. PMID: 31260023 No abstract available.
Coding Errors in Study of Meta-analyses With Falsified Data in the Results.
Garmendia CA. Garmendia CA. JAMA Intern Med. 2021 Mar 1;181(3):408-409. doi: 10.1001/jamainternmed.2020.7164. JAMA Intern Med. 2021. PMID: 33226433 No abstract available.

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References

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. - PubMed
1. 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.2014.7774 - DOI - PubMed
1. 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-A - DOI - PubMed
1. The Cochrane Collaboration Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0). https://training.cochrane.org/handbook. Accessed September 5, 2018.
1. 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.

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[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. - PubMed

[2] 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. - PubMed

[3] 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.2014.7774 - DOI - PubMed

[4] 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.2014.7774 - DOI - PubMed

[5] 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-A - DOI - PubMed

[6] 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-A - DOI - PubMed

[7] The Cochrane Collaboration Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0). https://training.cochrane.org/handbook. Accessed September 5, 2018.

[8] The Cochrane Collaboration Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0). https://training.cochrane.org/handbook. Accessed September 5, 2018.

[9] 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.

[10] 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.

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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

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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

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