P.024 Sex and gender reporting in clinical trials among neurological US Food and Drug Administration approvals Article Swipe
Liam Cooper-Brown
,
J Chen
,
J Chen
,
Abbas Ebadi
,
L. Wilson
,
Juying Xie
,
Barbara A. Bernhardt
,
Esther Bui
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1017/cjn.2024.131
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1017/cjn.2024.131
Background: Sex and gender are related but distinct determinants of disease, treatment response, and research reproducibility whose consideration is increasingly required for research funding. Nevertheless, the quality of sex and gender reporting in neurological randomized controlled trials (RCTs) remains unknown. Methods: This ongoing study of RCTs associated with Food and Drug Administration neurological drug approvals aims to determine the frequency of accurate reporting of RCT participants’ sex and gender. Secondary outcomes include changes in reporting over time and RCT design characteristics. Results: Preliminary analysis included 145 RCTs (153,410 participants) associated with 77 medications approved in 1985-2023, most commonly for epilepsy (19%), migraine (16%), and multiple sclerosis (16%). Sixty-six RCTs (45.5%) used sex-related terms appropriately. Nine RCTs (6.2%) reported gender accurately. Fifty-three RCTs (37%) used sex- or gender-related terms interchangeably. There are no statistically significant differences in the proportions of studies reporting sex and/or gender accurately when comparing those published until versus after 2017. No RCT reported sex or gender collection methods, definitions of sex or gender, or including sex or gender minority participants. Conclusions: Preliminary results suggest shortcomings in reporting sex and, especially, gender accurately and inclusively among neurological drug RCTs and no significant improvement thereof in recent years.
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Concepts
Metadata
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- Language
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- https://www.cambridge.org/core/services/aop-cambridge-core/content/view/B9A33558FB574984924DDB8AB49388C0/S0317167124001318a.pdf/div-class-title-p-024-sex-and-gender-reporting-in-clinical-trials-among-neurological-us-food-and-drug-administration-approvals-div.pdf
- OA Status
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- Related Works
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- OpenAlex ID
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All OpenAlex metadata
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https://openalex.org/W4398781429Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1017/cjn.2024.131Digital Object Identifier
- Title
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P.024 Sex and gender reporting in clinical trials among neurological US Food and Drug Administration approvalsWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2024Year of publication
- Publication date
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2024-05-24Full publication date if available
- Authors
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Liam Cooper-Brown, J Chen, J Chen, Abbas Ebadi, L. Wilson, Juying Xie, Barbara A. Bernhardt, Esther BuiList of authors in order
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https://doi.org/10.1017/cjn.2024.131Publisher landing page
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https://www.cambridge.org/core/services/aop-cambridge-core/content/view/B9A33558FB574984924DDB8AB49388C0/S0317167124001318a.pdf/div-class-title-p-024-sex-and-gender-reporting-in-clinical-trials-among-neurological-us-food-and-drug-administration-approvals-div.pdfDirect link to full text PDF
- Open access
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YesWhether a free full text is available
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bronzeOpen access status per OpenAlex
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https://www.cambridge.org/core/services/aop-cambridge-core/content/view/B9A33558FB574984924DDB8AB49388C0/S0317167124001318a.pdf/div-class-title-p-024-sex-and-gender-reporting-in-clinical-trials-among-neurological-us-food-and-drug-administration-approvals-div.pdfDirect OA link when available
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0Total citation count in OpenAlex
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| abstract_inverted_index.quality | 26 |
| abstract_inverted_index.related | 5 |
| abstract_inverted_index.remains | 38 |
| abstract_inverted_index.results | 175 |
| abstract_inverted_index.studies | 139 |
| abstract_inverted_index.suggest | 176 |
| abstract_inverted_index.thereof | 195 |
| abstract_inverted_index.(153,410 | 87 |
| abstract_inverted_index.Methods: | 40 |
| abstract_inverted_index.Results: | 81 |
| abstract_inverted_index.accurate | 61 |
| abstract_inverted_index.analysis | 83 |
| abstract_inverted_index.approved | 93 |
| abstract_inverted_index.commonly | 97 |
| abstract_inverted_index.disease, | 10 |
| abstract_inverted_index.distinct | 7 |
| abstract_inverted_index.epilepsy | 99 |
| abstract_inverted_index.funding. | 23 |
| abstract_inverted_index.included | 84 |
| abstract_inverted_index.methods, | 160 |
| abstract_inverted_index.migraine | 101 |
| abstract_inverted_index.minority | 171 |
| abstract_inverted_index.multiple | 104 |
| abstract_inverted_index.outcomes | 70 |
| abstract_inverted_index.reported | 117, 155 |
| abstract_inverted_index.required | 20 |
| abstract_inverted_index.research | 14, 22 |
| abstract_inverted_index.unknown. | 39 |
| abstract_inverted_index.Secondary | 69 |
| abstract_inverted_index.Sixty-six | 107 |
| abstract_inverted_index.approvals | 54 |
| abstract_inverted_index.comparing | 146 |
| abstract_inverted_index.determine | 57 |
| abstract_inverted_index.frequency | 59 |
| abstract_inverted_index.including | 167 |
| abstract_inverted_index.published | 148 |
| abstract_inverted_index.reporting | 31, 62, 74, 140, 179 |
| abstract_inverted_index.response, | 12 |
| abstract_inverted_index.sclerosis | 105 |
| abstract_inverted_index.treatment | 11 |
| abstract_inverted_index.1985-2023, | 95 |
| abstract_inverted_index.accurately | 144, 184 |
| abstract_inverted_index.associated | 46, 89 |
| abstract_inverted_index.collection | 159 |
| abstract_inverted_index.controlled | 35 |
| abstract_inverted_index.randomized | 34 |
| abstract_inverted_index.Background: | 0 |
| abstract_inverted_index.Fifty-three | 120 |
| abstract_inverted_index.Preliminary | 82, 174 |
| abstract_inverted_index.accurately. | 119 |
| abstract_inverted_index.definitions | 161 |
| abstract_inverted_index.differences | 134 |
| abstract_inverted_index.especially, | 182 |
| abstract_inverted_index.improvement | 194 |
| abstract_inverted_index.inclusively | 186 |
| abstract_inverted_index.medications | 92 |
| abstract_inverted_index.proportions | 137 |
| abstract_inverted_index.sex-related | 111 |
| abstract_inverted_index.significant | 133, 193 |
| abstract_inverted_index.Conclusions: | 173 |
| abstract_inverted_index.determinants | 8 |
| abstract_inverted_index.increasingly | 19 |
| abstract_inverted_index.neurological | 33, 52, 188 |
| abstract_inverted_index.shortcomings | 177 |
| abstract_inverted_index.Nevertheless, | 24 |
| abstract_inverted_index.consideration | 17 |
| abstract_inverted_index.participants) | 88 |
| abstract_inverted_index.participants. | 172 |
| abstract_inverted_index.statistically | 132 |
| abstract_inverted_index.Administration | 51 |
| abstract_inverted_index.appropriately. | 113 |
| abstract_inverted_index.gender-related | 126 |
| abstract_inverted_index.participants’ | 65 |
| abstract_inverted_index.reproducibility | 15 |
| abstract_inverted_index.characteristics. | 80 |
| abstract_inverted_index.interchangeably. | 128 |
| cited_by_percentile_year | |
| countries_distinct_count | 1 |
| institutions_distinct_count | 8 |
| citation_normalized_percentile.value | 0.12893388 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | False |