Hiding negative trials by pooling them: A secondary analysis of pooled-trials publication bias in FDA-registered antidepressant trials

Ymkje Anna De Vries, Annelieke M. Roest, Erick Turner, Peter De Jonge

Research output: Contribution to journalArticle

Abstract

BackgroundPrevious studies on reporting bias generally examined whether trials were published in stand-alone publications. In this study, we investigated whether pooled-trials publications constitute a specific form of reporting bias. We assessed whether negative trials were more likely to be exclusively published in pooled-trials publications than positive trials and examined the research questions, individual trial results, and conclusions presented in these articles.MethodsData from a cohort of 105 randomized controlled trials of 16 antidepressants were extracted from earlier publications and the corresponding Food and Drug Administration (FDA) reviews. A systematic literature search was conducted to identify pooled-trials publications.ResultsWe found 107 pooled-trials publications that reported results of 23 (72%) of 32 trials not published in stand-alone publications. Only two (3.8%) of 54 positive trials were published exclusively in pooled-trials publications, compared with 21 (41.1%) of 51 negative trials (p < 0.001). Thirteen (12%) of 107 publications had as primary aim to present data on the trial's primary research question (drug efficacy compared with placebo). Only four of these publications, reporting on five (22%) trials, presented individual efficacy data for the primary research question. Additionally, only five (5%) of 107 pooled-trials publications had a negative conclusion.ConclusionsCompared with positive trials, negative trials of antidepressants for depression were much more likely to be reported exclusively in pooled-trials publications. Pooled-trials publications flood the evidence base with often-redundant articles that, instead of addressing the original primary research question, present (positive) results on secondary questions. Therefore, pooled-trials publications distort the apparent risk-benefit profile of antidepressants.

Original languageEnglish (US)
JournalPsychological Medicine
DOIs
StateAccepted/In press - Jan 1 2018

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Publication Bias
United States Food and Drug Administration
Antidepressive Agents
Publications
Research

Keywords

  • Antidepressants
  • bias
  • depression
  • pooled-trials publication bias

ASJC Scopus subject areas

  • Applied Psychology
  • Psychiatry and Mental health

Cite this

Hiding negative trials by pooling them : A secondary analysis of pooled-trials publication bias in FDA-registered antidepressant trials. / De Vries, Ymkje Anna; Roest, Annelieke M.; Turner, Erick; De Jonge, Peter.

In: Psychological Medicine, 01.01.2018.

Research output: Contribution to journalArticle

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abstract = "BackgroundPrevious studies on reporting bias generally examined whether trials were published in stand-alone publications. In this study, we investigated whether pooled-trials publications constitute a specific form of reporting bias. We assessed whether negative trials were more likely to be exclusively published in pooled-trials publications than positive trials and examined the research questions, individual trial results, and conclusions presented in these articles.MethodsData from a cohort of 105 randomized controlled trials of 16 antidepressants were extracted from earlier publications and the corresponding Food and Drug Administration (FDA) reviews. A systematic literature search was conducted to identify pooled-trials publications.ResultsWe found 107 pooled-trials publications that reported results of 23 (72{\%}) of 32 trials not published in stand-alone publications. Only two (3.8{\%}) of 54 positive trials were published exclusively in pooled-trials publications, compared with 21 (41.1{\%}) of 51 negative trials (p < 0.001). Thirteen (12{\%}) of 107 publications had as primary aim to present data on the trial's primary research question (drug efficacy compared with placebo). Only four of these publications, reporting on five (22{\%}) trials, presented individual efficacy data for the primary research question. Additionally, only five (5{\%}) of 107 pooled-trials publications had a negative conclusion.ConclusionsCompared with positive trials, negative trials of antidepressants for depression were much more likely to be reported exclusively in pooled-trials publications. Pooled-trials publications flood the evidence base with often-redundant articles that, instead of addressing the original primary research question, present (positive) results on secondary questions. Therefore, pooled-trials publications distort the apparent risk-benefit profile of antidepressants.",
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N2 - BackgroundPrevious studies on reporting bias generally examined whether trials were published in stand-alone publications. In this study, we investigated whether pooled-trials publications constitute a specific form of reporting bias. We assessed whether negative trials were more likely to be exclusively published in pooled-trials publications than positive trials and examined the research questions, individual trial results, and conclusions presented in these articles.MethodsData from a cohort of 105 randomized controlled trials of 16 antidepressants were extracted from earlier publications and the corresponding Food and Drug Administration (FDA) reviews. A systematic literature search was conducted to identify pooled-trials publications.ResultsWe found 107 pooled-trials publications that reported results of 23 (72%) of 32 trials not published in stand-alone publications. Only two (3.8%) of 54 positive trials were published exclusively in pooled-trials publications, compared with 21 (41.1%) of 51 negative trials (p < 0.001). Thirteen (12%) of 107 publications had as primary aim to present data on the trial's primary research question (drug efficacy compared with placebo). Only four of these publications, reporting on five (22%) trials, presented individual efficacy data for the primary research question. Additionally, only five (5%) of 107 pooled-trials publications had a negative conclusion.ConclusionsCompared with positive trials, negative trials of antidepressants for depression were much more likely to be reported exclusively in pooled-trials publications. Pooled-trials publications flood the evidence base with often-redundant articles that, instead of addressing the original primary research question, present (positive) results on secondary questions. Therefore, pooled-trials publications distort the apparent risk-benefit profile of antidepressants.

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