Transparency of results reporting for depression treatment studies in ClinicalTrials.gov: a cross-sectional study

Karen B. Schmaling · Hailey S Landon · Tiffany B Nguyen · Robert M. Kaplan

8 citations0/0 files storedBMJ Evidence-Based Medicine

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Meta-analysis and systematic reviews Research Data Management Practices Pharmaceutical industry and healthcare

Abstract

OBJECTIVES: Depression affects an estimated 7% of the adult population at an estimated cost of over US$200 billion/year in the USA. Complete, transparent reporting of clinical trial data facilitates valid estimates of treatment efficacy. In the USA, ClinicalTrials.gov increases transparency through mandatory prospective trial registration and outcome reporting. We examined characteristics of the transparent reporting of depression treatment studies registered in ClinicalTrials.gov. DESIGN: Cross sectional. SETTING AND PARTICIPANTS: US-based studies identified in a search of ClinicalTrials.gov with depression as the condition, enrolling ages 18 and older, and completed between 1 January 2008 and 1 May 2019. INTERVENTIONS: All interventions were included. MAIN OUTCOMES AND MEASURES: The main outcome was whether any results were reported prior to 1 May 2020. Data were extracted regarding inclusion and exclusion criteria, publications related to the study and specification of hypotheses. RESULTS: 725 studies involving 156 634 patients met inclusion criteria. 416 (57.4%) of the studies posted some results. However, statistical test results were not included in 230 studies (55.3%). Most studies had data that could have been analysed and reported. Compared with studies without results, studies with any results were more likely to have hypotheses, include drug treatment conditions, and to have publications related to the study. CONCLUSIONS: Required study registration does not always result in transparent outcome reporting. Better compliance with mandated reporting and improved reporting standards would facilitate a more comprehensive representation of depression treatment research.

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References

2010CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials 2015The Economic Burden of Adults With Major Depressive Disorder in the United States (2005 and 2010)2014Impact of Spin in the Abstracts of Articles Reporting Results of Randomized Controlled Trials in the Field of Cancer: The SPIIN Randomized Controlled Trial 2011Completeness and Changes in Registered Data and Reporting Bias of Randomized Controlled Trials in ICMJE Journals after Trial Registration Policy 2014How does under-reporting of negative and inconclusive results affect the false-positive rate in meta-analysis? A simulation study 2015Change Score or Followup Score? An Empirical Evaluation of the Impact of Choice of Mean Difference Estimates 2020Efficacy and effectiveness studies of depression are not well-differentiated in the literature: a systematic review

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2023Depression trial results: A cross-sectional study of ClinicalTrials.gov

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