Variation in Accrual and Race/Ethnicity Reporting in Urological and Nonurological Related Cancer Trials.
J Urol
; 202(2): 385-391, 2019 08.
Article
em En
| MEDLINE
| ID: mdl-31074679
ABSTRACT
PURPOSE:
We performed a multiregistry analysis to assess relative differences in accrual sufficiency and race/ethnicity reporting in trials of common urological cancers and other nonurological solid organ tumors. MATERIALS ANDMETHODS:
We queried ClinicalTrials.gov and the ISRCTN (International Standard Randomised Controlled Trial Number) Registry for closed phase III and IV trials focused on prostate, colorectal, kidney, bladder, testicular, breast and lung cancer. Identified trials were cross-verified with appropriate published data sources. Comparative accrual sufficiency and rates of race/ethnicity reporting were calculated. Multivariable logistic regression analysis was performed to determine factors associated with accrual status and race/ethnicity reporting.RESULTS:
A total of 326 trials were identified based on our prespecified criteria, of which 63% reported sufficient accrual by time of closure and 58% reported data by race/ethnicity. Nonurological trials were significantly more likely to mention race data than urological trials (OR 3.25, 95% CI 1.24-8.55, p = 0.02). Industry sponsored trials were more likely to meet accrual targets than government funded projects (OR 5.44, 95% CI 1.64-18.20, p = 0.001). Although funding source did not influence race reporting, the reported recruitment of participants of African ethnicity was lower in industry sponsored trials (11.49% vs 3.18%, p <0.01). Two-thirds of the studies did not report baseline characteristics by African American race/ethnicity.CONCLUSIONS:
Insufficient accrual and inadequate race/ethnicity reporting are prevalent issues, limiting interpretation of the results of clinical trials of major solid organ malignancies. Addressing these shortcomings would enhance result validity by raising statistical power and improving the transparency of reporting to better evaluate the generalizability of results.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
/
Etnicidade
/
Ensaios Clínicos como Assunto
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Neoplasias Urológicas
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Grupos Raciais
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Protocolos de Ensaio Clínico como Assunto
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Neoplasias
Tipo de estudo:
Clinical_trials
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Prognostic_studies
Limite:
Female
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Humans
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Male
País como assunto:
America do norte
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article