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Cited by 63Pharmacovigilance and Adverse Drug ReactionsPharmaceutical industry and healthcareMeta-analysis and systematic reviews

Harms are assessed inconsistently and reported inadequately part 1: systematic adverse events

Open access
Mayo-Wilson, Evan, Fusco, Nicole, Li, Tianjing, Hong, Hwanhee, Canner, Joseph K., Dickersin, Kay, Bertizzolo, Lorenzo, Cowley, Terrie +14 more·2019·Journal of Clinical Epidemiology
DOI 10.1016/j.jclinepi.2019.04.022
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Abstract

OBJECTIVE: We examined nonsystematic adverse events (AEs) in Part 2 (of 2) of a study describing the assessment and reporting AEs in clinical trials. STUDY DESIGN AND SETTING: We examined 21 trials of gabapentin for neuropathic pain (52 sources) and seven trials of quetiapine for bipolar depression (80 sources) using data from the Multiple Data Sources study. We extracted and compared information about nonsystematic AEs (i.e., AEs that were not assessed for every participant), including AEs categorized as "serious." We recorded whether AEs were grouped by anatomic or physiological system. RESULTS: Trials of the same drug reported information about different AEs. Information in public sources was inadequate for decision-making. No public source reported all AEs, or all serious AEs, identified in nonpublic sources about the same trial. Of trials with only public sources, 2/15 (13%) gabapentin and 0/3 (0%) quetiapine trials grouped AEs by anatomic or physiological system. CONCLUSION: Public sources contained little information about nonsystematic AEs, including serious AEs. Grouping might make nonsystematic AEs easier to detect; however, most public sources did not report grouped AEs. Standards are needed to improve the collection and reporting of nonsystematic AEs so that stakeholders can use trials to assess the balance of potential benefits and harms.

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  • Specifying the methods of assessing, grouping, and analysing harms in the protocol helps to identify and deter the selective reporting of results in publications and registries.

    “Specifying the methods of assessing, grouping, and analysing harms in the protocol helps to identify and deter the selective reporting of results in publications and registries.280 281”

    From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [280]

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Research works printed but not linked: 2

  1. Zarin DA, Tse T, Williams RJ, Carr S. Trial reporting in Clinical- Trials. govdthe final rule. N Engl J Med 2016;375:1998e2004.
  2. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. In: ICH harmon- ised tripartite guideline: structure and content of clinical study reports E3. Available at http://www.ich.org/products/guidelines/efficacy/ efficacy-single/article/structure-and-content-of-clinical-study-reports. html. Accessed May 12, 2018.

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Authors
Mayo-Wilson, E., Fusco, N., Li, T., Hong, H., Canner, J. K., Dickersin, K., Bertizzolo, L., Cowley, T., Doshi, P., Ehmsen, J., Gresham, G., Guo, N., Haythornthwaite, J., Heyward, J., Pham, D., Payne, J., Rosman, L., Stuart, E., Suarez-Cuervo, C., Tolbert, E., Twose, C., & Vedula, S.
Affiliations
Johns Hopkins University (US)
ORCID
Venue
Journal of Clinical Epidemiology
Publisher
Elsevier BV
Published
2019-09
Volume
113
Pages
20-27
ISSN
0895-4356 (ISSN-L)
DOI
10.1016/j.jclinepi.2019.04.022
OpenAlex
W2943757653
Cited by
63
References
42
Citations by year
2026: 6 · 2025: 3 · 2024: 20 · 2023: 10 · 2022: 5 · 2021: 9 · 2020: 6 · 2019: 4
FWCI
4.42
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of Clinical Epidemiology (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
  • IUScholarWorks Open (Indiana University) (submittedVersion)
  • Pure Amsterdam UMC (submittedVersion, other-oa)
Funders
Patient-Centered Outcomes Research Institute
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords
serious adverse events, clinical trial reporting, harm assessment, gabapentin, neuropathic pain, quetiapine, bipolar depression, benefit-harm balance
MeSH terms
Data Accuracy, Quetiapine Fumarate, Gabapentin, Bipolar Disorder, Humans, Neuralgia, Randomized Controlled Trials as Topic, Research Report, Drug-Related Side Effects and Adverse Reactions

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