Craig Alexander Garmendia, PhDOffice of Bioresearch Monitoring Operations, Office of Regulatory AffairUS Food and Drug AdministrationMiami, Florida

Medical Research Metaanalyses Can Contain Corrupted Data Interview with:

Craig Alexander Garmendia, PhDOffice of Bioresearch Monitoring Operations, Office of Regulatory AffairUS Food and Drug AdministrationMiami, Florida

Dr. Garmendia

Craig Alexander Garmendia, PhD
Office of Bioresearch Monitoring Operations
Office of Regulatory Affairs
US Food and Drug Administration
Miami, Florida What is the background for this study? What are the main findings? 

Response: Clinical trials under the U.S. Food and Drug Administration’s (FDA) purview have been shown to suffer from falsified data. While the FDA warns researchers when falsified data are discovered, these data still make their way into medical literature.

In this novel study, Dr. Garmendia and colleagues conducted a systematic review to examine the effects of publications containing falsified data on meta-analyses using sensitivity analyses. Almost half of all meta-analyses had conclusions altered by publications containing falsified data, while nearly one-third of all analyses had considerable changes in outcomes. What should readers take away from your report?

Response: Falsified data can affect the original publication, thus leading to potential effects in subsequent meta-analyses and any resulting clinical or policy changes resulting from the findings of these studies. What recommendations do you have for future research as a result of this work?

Response: This study contributes to the literature that underscores the need for a robust sensitivity analysis for meta-analyses. In addition, it should add impetus for stronger prevention of publication of data that have been cited as having problems.

Disclosures: This study was conducted at Florida International University’s Robert Stempel College of Public Health and Social Work’s Department of Epidemiology. In addition, individuals from the university’s Department of Biostatistics and Department of Psychology were involved. Owning up to the university’s name, authors of this study come from Bosnia and Herzegovina, Colombia, India, Jordan, and the United States of America. Dr. Garmendia is employed by the FDA, but this article reflects the view of the authors and should not be construed to represent FDA’s views or policies.


Garmendia CA, Nassar Gorra L, Rodriguez AL, Trepka MJ, Veledar E, Madhivanan P. 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. Published online March 04, 2019. doi:10.1001/jamainternmed.2018.7661

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Last Updated on March 6, 2019 by Marie Benz MD FAAD