Quantifying Diversity and Representation in Pivotal Trials Leading to Marketing Authorization in Europe.
Demographics
Diversity
Ethnicity
Pivotal trials
Race
Representation
Journal
Therapeutic innovation & regulatory science
ISSN: 2168-4804
Titre abrégé: Ther Innov Regul Sci
Pays: Switzerland
ID NLM: 101597411
Informations de publication
Date de publication:
09 2022
09 2022
Historique:
received:
17
02
2022
accepted:
19
05
2022
pubmed:
11
6
2022
medline:
10
8
2022
entrez:
10
6
2022
Statut:
ppublish
Résumé
Following up on a study from 2019, Tufts CSDD collected and analyzed data on demographic disparities and representation in pivotal trials supporting the marketing authorization of novel drugs and biologics approved in Europe between 2007 and 2019. Data were collected from products' EPAR, the EUDRACT database, and other publicly available sources, and compared to indication-specific demographic data or a census estimate. In total, data were collected on 446 drugs and 943 pivotal trials. Results indicated that gender demographic data were only reported for 80.7% of pivotal trials, and that racial and ethnicity demographic data were reported less often (64.1% and 29.9% of pivotal trials, respectively). Results also indicated that non-white racial identities were under-represented by more than 20% in nearly half or more of pivotal trials. Guidelines encouraging the reporting of patient demographic data are insufficient and availability of the data is problematic. The available data suggest that under-representation in pivotal trials is widespread.
Sections du résumé
BACKGROUND
Following up on a study from 2019, Tufts CSDD collected and analyzed data on demographic disparities and representation in pivotal trials supporting the marketing authorization of novel drugs and biologics approved in Europe between 2007 and 2019.
METHODS
Data were collected from products' EPAR, the EUDRACT database, and other publicly available sources, and compared to indication-specific demographic data or a census estimate. In total, data were collected on 446 drugs and 943 pivotal trials.
RESULTS
Results indicated that gender demographic data were only reported for 80.7% of pivotal trials, and that racial and ethnicity demographic data were reported less often (64.1% and 29.9% of pivotal trials, respectively). Results also indicated that non-white racial identities were under-represented by more than 20% in nearly half or more of pivotal trials.
CONCLUSIONS
Guidelines encouraging the reporting of patient demographic data are insufficient and availability of the data is problematic. The available data suggest that under-representation in pivotal trials is widespread.
Identifiants
pubmed: 35680722
doi: 10.1007/s43441-022-00421-0
pii: 10.1007/s43441-022-00421-0
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
795-804Informations de copyright
© 2022. The Drug Information Association, Inc.
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