ArticleJournal of the American Medical Informatics Association : JAMIA2021
Towards clinical data-driven eligibility criteria optimization for interventional COVID-19 clinical trials.
Article in Journal of the American Medical Informatics Association : JAMIA, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Utilization of EHRs for clinical trials: a systematic review.BMC medical research methodology · 2024Pooled it
- CLEAR: A vision to support clinical evidence lifecycle with continuous learning.Journal of biomedical informatics · 2025Article
- Eligibility of Asian and European registry patients for phase III trials in heart failure with reduced ejection fraction.ESC heart failure · 2024Article
- Clinical Research Informatics: a Decade-in-Review.Yearbook of medical informatics · 2024Review
- A review of research on eligibility criteria for clinical trials.Clinical and experimental medicine · 2023Review
- A data-driven approach to optimizing clinical study eligibility criteria.Journal of biomedical informatics · 2023Article
- Relative bed allocation for COVID-19 patients, EHR investments, and COVID-19 mortality outcomes.PloS one · 2023Article
- Improving Cancer Care for Patients With CKD: The Need for Changes in Clinical Trials.Kidney international reports · 2022Review
- Leveraging electronic health record data for clinical trial planning by assessing eligibility criteria's impact on patient count and safety.Journal of biomedical informatics · 2022Article
- Impacts of Eligibility Criteria on Trial Participants' Age in Alzheimer's Disease Clinical Trials.AMIA ... Annual Symposium proceedings. AMIA Symposium · 2022Article
- The potential role of EHR data in optimizing eligibility criteria definition for cardiovascular outcome trials.International journal of medical informatics · 2021Article
- A Framework for Systematic Assessment of Clinical Trial Population Representativeness Using Electronic Health Records Data.Applied clinical informatics · 2021Article
- Article
- How the clinical research community responded to the COVID-19 pandemic: an analysis of the COVID-19 clinical studies in ClinicalTrials.gov.JAMIA open · 2021Article
- AI uses patient data to optimize selection of eligibility criteria for clinical trials.Nature · 2021Article
- Identification of drugs associated with reduced severity of COVID-19: A case-control study in a large population.medRxiv : the preprint server for health sciences · 2021Article
- The maturation of clinical research informatics as a subdomain of biomedical informatics.Journal of the American Medical Informatics Association : JAMIA · 2021Article
- How the clinical research community responded to the COVID-19 pandemic: An analysis of the COVID-19 clinical studies in ClinicalTrials.gov.medRxiv : the preprint server for health sciences · 2020Article
Corrections and comments
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Authors and funding
15 authors.
Funding
Abstract
objectiveThis research aims to evaluate the impact of eligibility criteria on recruitment and observable clinical outcomes of COVID-19 clinical trials using electronic health record (EHR) data. MATERIALS AND
methodsOn June 18, 2020, we identified frequently used eligibility criteria from all the interventional COVID-19 trials in ClinicalTrials.gov (n = 288), including age, pregnancy, oxygen saturation, alanine/aspartate aminotransferase, platelets, and estimated glomerular filtration rate. We applied the frequently used criteria to the EHR data of COVID-19 patients in Columbia University Irving Medical Center (CUIMC) (March 2020-June 2020) and evaluated their impact on patient accrual and the occurrence of a composite endpoint of mechanical ventilation, tracheostomy, and in-hospital death.
resultsThere were 3251 patients diagnosed with COVID-19 from the CUIMC EHR included in the analysis. The median follow-up period was 10 days (interquartile range 4-28 days). The composite events occurred in 18.1% (n = 587) of the COVID-19 cohort during the follow-up. In a hypothetical trial with common eligibility criteria, 33.6% (690/2051) were eligible among patients with evaluable data and 22.2% (153/690) had the composite event. DISCUSSION: By adjusting the thresholds of common eligibility criteria based on the characteristics of COVID-19 patients, we could observe more composite events from fewer patients.
conclusionsThis research demonstrated the potential of using the EHR data of COVID-19 patients to inform the selection of eligibility criteria and their thresholds, supporting data-driven optimization of participant selection towards improved statistical power of COVID-19 trials.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.