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Comparison of Data on Serious Adverse Events and Mortality in ClinicalTrials.gov, Corresponding Journal Articles, and FDA Medical Reviews: Cross-Sectional Analysis

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  • Richeek Pradhan

    (University of Massachusetts Medical School)

  • Sonal Singh

    (University of Massachusetts Medical School)

Abstract

Introduction Inconsistencies in data on serious adverse events (SAEs) and mortality in ClinicalTrials.gov and corresponding journal articles pose a challenge to research transparency. Objective The objective of this study was to compare data on SAEs and mortality from clinical trials reported in ClinicalTrials.gov and corresponding journal articles with US Food and Drug Administration (FDA) medical reviews. Methods We conducted a cross-sectional study of a randomly selected sample of new molecular entities approved during the study period 1 January 2013 to 31 December 2015. We extracted data on SAEs and mortality from 15 pivotal trials from ClinicalTrials.gov and corresponding journal articles (the two index resources), and FDA medical reviews (reference standard). We estimated the magnitude of deviations in rates of SAEs and mortality between the index resources and the reference standard. Results We found deviations in rates of SAEs (30% in ClinicalTrials.gov and 30% in corresponding journal articles) and mortality (72% in ClinicalTrials.gov and 53% in corresponding journal articles) when compared with the reference standard. The intra-class correlation coefficient between the three resources was 0.99 (95% confidence interval [CI] 0.98–0.99) for SAE rates and 0.99 (95% CI 0.97–0.99) for mortality rates. Conclusion There are differences in data on rates of SAEs and mortality in randomized clinical trials in both ClinicalTrials.gov and journal articles compared with FDA reviews. Further efforts should focus on decreasing existing discrepancies to enhance the transparency and reproducibility of data reporting in clinical trials.

Suggested Citation

  • Richeek Pradhan & Sonal Singh, 2018. "Comparison of Data on Serious Adverse Events and Mortality in ClinicalTrials.gov, Corresponding Journal Articles, and FDA Medical Reviews: Cross-Sectional Analysis," Drug Safety, Springer, vol. 41(9), pages 849-857, September.
    • Handle: RePEc:spr:drugsa:v:41:y:2018:i:9:d:10.1007_s40264-018-0666-y
    DOI: 10.1007/s40264-018-0666-y
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    References listed on IDEAS

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    1. Su Golder & Yoon K Loke & Kath Wright & Gill Norman, 2016. "Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review," PLOS Medicine, Public Library of Science, vol. 13(9), pages 1-22, September.
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