دورية أكاديمية
Feasibility of Using Oncology-Specific Electronic Health Record (EHR) Data to Emulate Clinical Trial Eligibility Criteria
| العنوان: | Feasibility of Using Oncology-Specific Electronic Health Record (EHR) Data to Emulate Clinical Trial Eligibility Criteria |
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| المؤلفون: | Thomas W. Wilson, Joseph T. Dye, Sarah Spark, Nicholas J. Robert, Janet L. Espirito, E. Susan Amirian |
| المصدر: | Pharmacoepidemiology, Vol 2, Iss 2, Pp 140-147 (2023) |
| بيانات النشر: | MDPI AG, 2023. |
| سنة النشر: | 2023 |
| المجموعة: | LCC:Therapeutics. Pharmacology LCC:Other systems of medicine LCC:Public aspects of medicine |
| مصطلحات موضوعية: | clinical trial emulation, electronic health records, observational studies, eligibility criteria, Therapeutics. Pharmacology, RM1-950, Other systems of medicine, RZ201-999, Public aspects of medicine, RA1-1270 |
| الوصف: | We examined eligibility criteria from recent oncology clinical trials to see whether real-world data (RWD) from electronic health records (EHRs) could be used to create external control groups for clinical trials. Trials were identified from the Aggregate Analysis of ClinicalTrials.gov database; the selected trials were for oncology drugs approved by the FDA in 2020. Verbatim text from trial inclusion and exclusion criteria was qualitatively assessed by an expert panel to determine if criteria could be ascertained from structured and unstructured EHR data. Identified criteria were categorized (cancer-related, comorbidity-related, demographic, functional status, and trial operations) and subcategorized. Among 53 identified trials, 20 met the requirements for study inclusion, which included 463 eligibility criteria. Percentages of criteria by category were as follows: cancer-related factors (46%), comorbidities (20%), functional status (18%), trial operations (14%), and demographics (2%). For 18 of the 20 trials, 80% of the eligibility criteria could be ascertained with RWD; for 4 of the 20, it was 100%. When trial operation-specific criteria were excluded, all 20 met the 100% threshold. Our study indicates that both structured and unstructured data from community-based oncology-specific EHRs can be used for determining patient eligibility for external control arms for clinical trials. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 2813-0618 |
| Relation: | https://www.mdpi.com/2813-0618/2/2/13; https://doaj.org/toc/2813-0618 |
| DOI: | 10.3390/pharma2020013 |
| URL الوصول: | https://doaj.org/article/2387352dbbe0472d98158d1e3b4cb64b |
| رقم الأكسشن: | edsdoj.2387352dbbe0472d98158d1e3b4cb64b |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 28130618 |
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| DOI: | 10.3390/pharma2020013 |