Growth in eligibility criteria content and failure to accrue among National Cancer Institute (NCI)‐affiliated clinical trials

Autor: John S. Peterson, Deborah Plana, Danielle S. Bitterman, Skyler Bryce Johnson, Hugo J. W. L. Aerts, Benjamin Harris Kann
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Cancer Medicine, Vol 12, Iss 4, Pp 4715-4724 (2023)
Druh dokumentu: article
ISSN: 2045-7634
DOI: 10.1002/cam4.5276
Popis: Abstract Background Cancer trial accrual is a national priority, yet up to 20% of trials fail to accrue. Trial eligibility criteria growth may be associated with accrual failure. We sought to quantify eligibility criteria growth within National Cancer Institute (NCI)‐affiliated trials and determine impact on accrual. Methods Utilizing the Aggregated Analysis of ClinicalTrials.gov, we analyzed phase II/III interventional NCI‐affiliated trials initiated between 2008 and 2018. Eligibility criteria growth was assessed via number of unique content words within combined inclusion and exclusion criteria. Association between unique word count and accrual failure was evaluated with multivariable logistic regression, adjusting for known predictors of failure. Medical terms associated with accrual failure were identified via natural language processing and categorized. Results Of 1197 trials, 231 (19.3%) failed due to low accrual. Accrual failure rate increased with eligibility criteria growth, from 11.8% in the lowest decile (12–112 words) to 29.4% in the highest decile (445–750 words). Median eligibility criteria increased over time, from 214 (IQR [23, 282]) unique content words in 2008 to 417 (IQR [289, 514]) in 2018 (r2 = 0.73, P
Databáze: Directory of Open Access Journals
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