Are Anti-Depressants as Safe as Reported? A Review of Publication and Outcome Reporting Bias in Trials Investigating Pediatric Depression

Mathiske, Carlotta Mae (2022) Are Anti-Depressants as Safe as Reported? A Review of Publication and Outcome Reporting Bias in Trials Investigating Pediatric Depression. Bachelor thesis, Psychology.

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Abstract

Major Depressive Disorder is one of the leading causes of youth suicide, today. Anti-depressants have been shown to act as effective countermeasures, but such drugs should not be administered without assessing their risk-benefit ratio. This study investigates whether this can be impeded by publication and outcome reporting biases in clinical trials, in particular, for widely prescribed substances such as escitalopram and fluoxetine. It compares safety data provided in the Food and Drug Administration’s (FDA) Drug Approval Packages (DAPs) with published articles about corresponding trials, with a focus on the reporting of adverse and serious adverse events, as well as suicide attempts. After data extraction and quantitative comparison, it was found that the older articles are missing large amounts of data compared to the more recent ones. Moreover, the FDA’s reports presenting most safety data in a pooled manner make it difficult to identify the origins of pertinent data. Despite these data limitations, it was possible to determine some discrepancies between the DAPs and at least two articles, as well as within the DAPs themselves. These issues suggested further study of the organizational setup, including the affiliations, and grouping of authors, for the examined trials. This revealed further indications of bias in trial execution and publication steps. Missing transparency in publications makes it impossible for clinicians to assess the real risk-benefits-ratio properly, as they are then limited in their ability to identify early signs of AEs. Lastly, approaches to mitigate publication and outcome reporting bias are presented.

Item Type:	Thesis (Bachelor)
Supervisor name:	Roest, A.M.
Degree programme:	Psychology
Differentiation route:	Other [Bachelor Psychology]
Date Deposited:	25 Mar 2022 09:30
Last Modified:	25 Mar 2022 09:30
URI:	http://gmwpublic.studenttheses.ub.rug.nl/id/eprint/329

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