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Introduction <p>Complete and consistent reporting of adverse events (AE) affects decisions in clinical practice. We conducted a cross-sectional study aiming to assess transparency and completeness of reported adverse events from randomized clinical trials (RCTs) on pharmacological interventions, including biologicals, to treat Coronavirus disease 2019 (COVID-19) registered on ClinicalTrials.gov on or after January 1, 2020, and updated on or before May 31, 2021, along with corresponding publications.</p> Aim <p>We aimed to assess the completeness and consistency of adverse event and all-cause mortality reporting between ClinicalTrials.gov and corresponding publications.</p> Method <p>We conducted a cross-sectional comparison of safety reporting between ClinicalTrials.gov registry and peer-reviewed publications of RCTs investigating COVID-19 pharmacological interventions, including biologicals. Two authors evaluated RCTs to reach κ ≥ 0.80.</p> Results <p>A total of 68 trials were assessed for discrepancies in adverse event and all-cause mortality data. Thirty-one (46%) were industry-funded, and 44 (65%) were double-blind randomized clinical trials. Forty-nine (72%) publications had discordant counts of serious adverse events (SAE) descriptions, 35 (51%) had discrepancies in the number of patients affected by SAE, and 11 (16%) omitted all-cause mortality compared to the records in the ClinicalTrials.gov registry.</p> Conclusion <p>Discrepant reporting of AEs and essential trial data was high in trials on COVID-19 therapeutics.</p>

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Evaluation of consistency in adverse event reporting between trial registry and publications in COVID-19 pharmacological intervention trials

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月13日

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  • Mia Strikić,
  • Shelly Melissa Pranić

摘要

Introduction

Complete and consistent reporting of adverse events (AE) affects decisions in clinical practice. We conducted a cross-sectional study aiming to assess transparency and completeness of reported adverse events from randomized clinical trials (RCTs) on pharmacological interventions, including biologicals, to treat Coronavirus disease 2019 (COVID-19) registered on ClinicalTrials.gov on or after January 1, 2020, and updated on or before May 31, 2021, along with corresponding publications.

Aim

We aimed to assess the completeness and consistency of adverse event and all-cause mortality reporting between ClinicalTrials.gov and corresponding publications.

Method

We conducted a cross-sectional comparison of safety reporting between ClinicalTrials.gov registry and peer-reviewed publications of RCTs investigating COVID-19 pharmacological interventions, including biologicals. Two authors evaluated RCTs to reach κ ≥ 0.80.

Results

A total of 68 trials were assessed for discrepancies in adverse event and all-cause mortality data. Thirty-one (46%) were industry-funded, and 44 (65%) were double-blind randomized clinical trials. Forty-nine (72%) publications had discordant counts of serious adverse events (SAE) descriptions, 35 (51%) had discrepancies in the number of patients affected by SAE, and 11 (16%) omitted all-cause mortality compared to the records in the ClinicalTrials.gov registry.

Conclusion

Discrepant reporting of AEs and essential trial data was high in trials on COVID-19 therapeutics.