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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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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.

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Authors and Affiliations

  1. Department of Quantitative Health Sciences, University of Massachusetts Medical School, 55 Lake Ave North, Worcester, MA, 01655-0002, USA

    Richeek Pradhan

  2. Department of Family Medicine and Community Health, Meyers Primary Care Institute, University of Massachusetts Medical School, 55 Lake Ave North, Worcester, MA, 01655-0002, USA

    Sonal Singh

Authors
  1. Richeek Pradhan
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  2. Sonal Singh
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Correspondence to Sonal Singh.

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Funding

No sources of funding were used to assist in the preparation of this study.

Conflicts of interest

Richeek Pradhan and Sonal Singh have no conflicts of interest relevant to the content of this study.

Ethical standards

This research was conducted using publicly available data and did not entail any primary data collection from patients. No Independent Review Board approval was sought.

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Pradhan, R., Singh, S. Comparison of Data on Serious Adverse Events and Mortality in ClinicalTrials.gov, Corresponding Journal Articles, and FDA Medical Reviews: Cross-Sectional Analysis. Drug Saf 41, 849–857 (2018). https://doi.org/10.1007/s40264-018-0666-y

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  • DOI: https://doi.org/10.1007/s40264-018-0666-y

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