Feasibility of Using Oncology-Specific Electronic Health Record (EHR) Data to Emulate Clinical Trial Eligibility Criteria
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...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-05-01
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| Series: | Pharmacoepidemiology |
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| Online Access: | https://www.mdpi.com/2813-0618/2/2/13 |
| _version_ | 1797593027488776192 |
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| author | Thomas W. Wilson Joseph T. Dye Sarah Spark Nicholas J. Robert Janet L. Espirito E. Susan Amirian |
| author_facet | Thomas W. Wilson Joseph T. Dye Sarah Spark Nicholas J. Robert Janet L. Espirito E. Susan Amirian |
| author_sort | Thomas W. Wilson |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T02:01:41Z |
| format | Article |
| id | doaj.art-2387352dbbe0472d98158d1e3b4cb64b |
| institution | Directory Open Access Journal |
| issn | 2813-0618 |
| language | English |
| last_indexed | 2024-03-11T02:01:41Z |
| publishDate | 2023-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmacoepidemiology |
| spelling | doaj.art-2387352dbbe0472d98158d1e3b4cb64b2023-11-18T12:06:29ZengMDPI AGPharmacoepidemiology2813-06182023-05-012214014710.3390/pharma2020013Feasibility of Using Oncology-Specific Electronic Health Record (EHR) Data to Emulate Clinical Trial Eligibility CriteriaThomas W. Wilson0Joseph T. Dye1Sarah Spark2Nicholas J. Robert3Janet L. Espirito4E. Susan Amirian5Real-World Research, Ontada, Irving, TX 75039, USAReal-World Research, Ontada, Irving, TX 75039, USAReal-World Research, Ontada, Irving, TX 75039, USAReal-World Research, Ontada, Irving, TX 75039, USAReal-World Research, Ontada, Irving, TX 75039, USAReal-World Research, Ontada, Irving, TX 75039, USAWe 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.https://www.mdpi.com/2813-0618/2/2/13clinical trial emulationelectronic health recordsobservational studieseligibility criteria |
| spellingShingle | Thomas W. Wilson Joseph T. Dye Sarah Spark Nicholas J. Robert Janet L. Espirito E. Susan Amirian Feasibility of Using Oncology-Specific Electronic Health Record (EHR) Data to Emulate Clinical Trial Eligibility Criteria Pharmacoepidemiology clinical trial emulation electronic health records observational studies eligibility criteria |
| title | Feasibility of Using Oncology-Specific Electronic Health Record (EHR) Data to Emulate Clinical Trial Eligibility Criteria |
| title_full | Feasibility of Using Oncology-Specific Electronic Health Record (EHR) Data to Emulate Clinical Trial Eligibility Criteria |
| title_fullStr | Feasibility of Using Oncology-Specific Electronic Health Record (EHR) Data to Emulate Clinical Trial Eligibility Criteria |
| title_full_unstemmed | Feasibility of Using Oncology-Specific Electronic Health Record (EHR) Data to Emulate Clinical Trial Eligibility Criteria |
| title_short | Feasibility of Using Oncology-Specific Electronic Health Record (EHR) Data to Emulate Clinical Trial Eligibility Criteria |
| title_sort | feasibility of using oncology specific electronic health record ehr data to emulate clinical trial eligibility criteria |
| topic | clinical trial emulation electronic health records observational studies eligibility criteria |
| url | https://www.mdpi.com/2813-0618/2/2/13 |
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