Operational efficiency

Assessing clinical site readiness for electronic health record (EHR)-to-electronic data capture (EDC) automated data collection

Posted on by Kayla Korzekwinski

Contemporary Clinical Trials • May 2023

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Eisenstein EL, Zozus MN, Garza MY, Lanham HJ, Adagarla B, Walden A, Zimmerman KO, Kumar KR

eSource software is used to automatically copy a patient’s electronic health record data into a clinical study’s electronic case report form. However, there is little evidence to assist sponsors in identifying the best sites for multi-center eSource studies. This site developed an eSource site readiness survey. The survey was administered to principal investigators, clinical research coordinators, and chief research information officers at Pediatric Trial Network sites.

Evaluating Site-Level Implementations of the HL7 FHIR Standard to Support eSource Data Exchange in Clinical Research

Posted on by Kayla Korzekwinski

Studies in Health Technology and Informatics • May 2021

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Garza MY, Eisenstein E, Kumar KR, Zimmerman KO, Zozus M
Direct extraction and use of electronic health record (EHR) data is a long-term and multifaceted endeavor. A systematic mapping of study data elements was used to measure the coverage of the Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) standard for a federally sponsored, pragmatic cardiovascular randomized controlled trial (RCT) targeting adults. Researchers evaluated site-level implementations of the HL7® FHIR® standard to investigate study- and site-level differences that could affect coverage and offer insight into the feasibility of a FHIR-based eSource solution for multicenter clinical research.

Creation of a Multicenter Pediatric Inpatient Data Repository Derived from Electronic Health Records

Posted on by Kayla Korzekwinski

Applied Clinical Informatics Journal • March 2019

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Hornik CP, Atz AM, Bendel C, Chan F, Downes K, Grundmeier R, Fogel B, Gipson D, Laughon M, Miller M, Smith M, Livingston C, Kluchar C, Heath A, Jarrett C, McKerlie B, Patel H, Hunter C; Best Pharmaceuticals for Children Act Pediatric Trials Network

Integration of electronic health records (EHRs) data across sites and access to that data remain limited. This study developed an EHR-based pediatric inpatient repository using nine U.S. centers from the National Institute of Child Health and Human Development Pediatric Trials Network.

Optimizing operational efficiencies in early phase trials: The Pediatric Trials Network experience

Posted on by Kayla Korzekwinski

Contemporary Clinical Trials • March 2016

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England A, Wade K, Smith PB, Berezny K, Laughon M; Best Pharmaceuticals for Children Act — Pediatric Trials Network Administrative Core Committee.

Performing drug trials in pediatrics is challenging. In support of the Best Pharmaceuticals for Children Act, the Eunice Kennedy Shriver National Institute of Child Health and Human Development funded the formation of the Pediatric Trials Network (PTN) in 2010. Since its inception, the PTN has developed strategies to increase both efficiency and safety of pediatric drug trials. Through use of innovative techniques such as sparse and scavenged blood sampling as well as opportunistic study design, participation in trials has grown. The PTN has also strived to improve consistency of adverse event reporting in neonatal drug trials through the development of a standardized adverse event table. We review how the PTN is optimizing operational efficiencies in pediatric drug trials to increase the safety of drugs in children.