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

Mia Strikić; Shelly Melissa Pranić

Abstract: ## RESEARCH Evaluation of consistency in adverse event reporting between trial registry and publications in COVID-19 pharmacological intervention trials Mia Strikić 1 · Shelly Melissa Pranić 2,3 Received: 8 December 2025 / Accepted: 8 March 2026 © The Author(s) 2026 Abstract 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 peerreviewed 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. Keywords Adverse events · ClinicalTrials.gov · COVID-19 · Drug safety · Randomized controlled trials Impact statements - Adverse event and mortality data for COVID-19 pharmacological interventions are frequently reported inconsistently between ClinicalTrials.gov and corresponding journal publications. * Mia Strikić miastrikic.ms@gmail.com 1 Department of Mental Health, Teaching Institute for Public Health Split, Vukovarska 46, 21000 Split, Croatia 2 Department of Public Health, University of Split School of Medicine, Šoltanska 2A, 21000 Split, Croatia 3 Cochrane Croatia, Šoltanska 2A, 21000 Split, Croatia - Reliable and consistent safety data reporting is essential for informed medication review, patient counselling, and clinical decision-making in pharmacy practice. - Strengthening adherence to reporting standards could improve decision- making and patient safety.

DOI record: { "DOI": "10.1007/s11096-026-02130-2", "ISSN": [ "2210-7711" ], "URL": "http://dx.doi.org/10.1007/s11096-026-02130-2", "abstract": "Abstract\n \n Introduction\n 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.\n \n \n Aim\n We aimed to assess the completeness and consistency of adverse event and all-cause mortality reporting between ClinicalTrials.gov and corresponding publications.\n \n \n Method\n 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.\n \n \n Results\n 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.\n \n \n Conclusion\n Discrepant reporting of AEs and essential trial data was high in trials on COVID-19 therapeutics.\n ", "alternative-id": [ "2130" ], "assertion": [ { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Received", "name": "received", "order": 1, "value": "8 December 2025" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Accepted", "name": "accepted", "order": 2, "value": "8 March 2026" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "First Online", "name": "first_online", "order": 3, "value": "13 April 2026" }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "name": "Ethics", "order": 1 }, { "group": { "label": "Competing interests", "name": "EthicsHeading" }, "name": "Ethics", "order": 2, "value": "The authors declare no competing interests." }, { "group": { "label": "Ethics approval", "name": "EthicsHeading" }, "name": "Ethics", "order": 3, "value": "There was no need for ethics approval since we did not include any participants or animals in our cross-sectional study." } ], "author": [ { "ORCID": "https://orcid.org/0000-0002-3905-7069", "affiliation": [], "authenticated-orcid": false, "family": "Strikić", "given": "Mia", "sequence": "first" }, { "ORCID": "https://orcid.org/0000-0001-5524-1723", "affiliation": [], "authenticated-orcid": false, "family": "Pranić", "given": "Shelly Melissa", "sequence": "additional" } ], "container-title": "International Journal of Clinical Pharmacy", "container-title-short": "Int J Clin Pharm", "content-domain": { "crossmark-restriction": false, "domain": [ "link.springer.com" ] }, "created": { "date-parts": [ [ 2026, 4, 13 ] ], "date-time": "2026-04-13T04:17:23Z", "timestamp": 1776053843000 }, "deposited": { "date-parts": [ [ 2026, 4, 13 ] ], "date-time": "2026-04-13T04:17:30Z", "timestamp": 1776053850000 }, "indexed": { "date-parts": [ [ 2026, 4, 13 ] ], "date-time": "2026-04-13T04:49:58Z", "timestamp": 1776055798858, "version": "3.50.1" }, "is-referenced-by-count": 0, "issued": { "date-parts": [ [ 2026, 4, 13 ] ] }, "language": "en", "license": [ { "URL": "https://creativecommons.org/licenses/by/4.0", "content-version": "tdm", "delay-in-days": 0, "start": { "date-parts": [ [ 2026, 4, 13 ] ], "date-time": "2026-04-13T00:00:00Z", "timestamp": 1776038400000 } }, { "URL": "https://creativecommons.org/licenses/by/4.0", "content-version": "vor", "delay-in-days": 0, "start": { "date-parts": [ [ 2026, 4, 13 ] ], "date-time": "2026-04-13T00:00:00Z", "timestamp": 1776038400000 } } ], "link": [ { "URL": "https://link.springer.com/content/pdf/10.1007/s11096-026-02130-2.pdf", "content-type": "application/pdf", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://link.springer.com/article/10.1007/s11096-026-02130-2", "content-type": "text/html", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://link.springer.com/content/pdf/10.1007/s11096-026-02130-2.pdf", "content-type": "application/pdf", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "297", "original-title": [], "prefix": "10.1007", "published": { "date-parts": [ [ 2026, 4, 13 ] ] }, "published-online": { "date-parts": [ [ 2026, 4, 13 ] ] }, "publisher": "Springer Science and Business Media LLC", "reference": [ { "key": "2130_CR1", "unstructured": "U.S. Food and Drug Administration. 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