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A point-of-care pharmacokinetic/pharmacodynamic trial in critically ill children: Study design and feasibility
Elizabeth J Thompson1, Henry P Foote1, Kevin D Hill1,2
1Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.
Insights
The Opportunistic PK/PD Trial in Critically Ill Children with Heart Disease (OPTIC) uses a point-of-care approach to efficiently gather pharmacokinetic (PK) and pharmacodynamic (PD) data in children. This method aims to overcome traditional barriers in pediatric drug development.
Area of Science:
- Pediatric critical care medicine
- Clinical pharmacology
- Translational science
Background:
- Pediatric drug development requires high-quality pharmacokinetic (PK), pharmacodynamic (PD), and safety studies.
- Point-of-care trials in adults have improved trial efficiency and patient participation.
- The feasibility of point-of-care trials for pediatric PK/PD studies is promising but not yet established.
Purpose of the Study:
- To implement a programmatic point-of-care approach for PK/PD trials in critically ill children with heart disease.
- To overcome barriers inherent in traditional pediatric PK/PD studies.
- To generate crucial safety, efficacy, PK, and PD data across diverse pediatric populations and medications.
Main Methods:
- Prospective, open-label, non-randomized point-of-care trial design.
- Characterization of PK/PD and safety of multiple drugs administered during routine care.
- Utilizes opportunistic biospecimen sampling and electronic health record (EHR) data.
- Streamlined study structure with a single informed consent form and drug-specific appendices.
- Automated data collection from EHR sources (demographics, medications, labs, vitals) to minimize participant burden.
- Data validation across multiple sources to ensure accuracy.
Main Results:
- N/A - Study design and methodology focused.
Conclusions:
- The OPTIC trial's point-of-care design and automated data acquisition offer a high-efficiency, minimal-burden approach for pediatric drug development.
- This innovative model has the potential to accelerate the availability of essential data for historically understudied pediatric populations.
- Facilitates drug development by generating critical PK/PD and safety data in critically ill children.
Background:
High-quality, efficient, pharmacokinetic (PK), pharmacodynamic (PD), and safety studies in children are needed. Point-of-care trials in adults have facilitated clinical trial participation for patients and providers, minimized the disruption of clinical workflow, and capitalized on routine data collection. The feasibility and value of point-of-care trials to study PK/PD in children are unknown, but appear promising. The Opportunistic PK/PD Trial in Critically Ill Children with Heart Disease (OPTIC) is a programmatic point-of-care approach to PK/PD trials in critically ill children that seeks to overcome barriers of traditional pediatric PK/PD studies to generate safety, efficacy, PK, and PD data across multiple medications, ages, and disease processes.
Methods:
This prospective, open-label, non-randomized point-of-care trial will characterize the PK/PD and safety of multiple drugs given per routine care to critically ill children with heart disease using opportunistic and scavenged biospecimen samples and data collected from the electronic health record. OPTIC has one informed consent form with drug-specific appendices, streamlining study structure and institutional review board approval. OPTIC capitalizes on routine data collection through multiple data sources that automatically capture demographics, medications, laboratory values, vital signs, flowsheets, and other clinical data. This innovative automatic data collection minimizes the burden of data collection and facilitates trial conduct. Data will be validated across sources to ensure accuracy of dataset variables.
Discussion:
OPTIC's point-of-care trial design and automated data acquisition via the electronic health record may provide a mechanism for conducting minimal risk, minimal burden, high efficiency trials and support drug development in historically understudied patient populations.
Trial Registration:
clinicaltrials.gov number: NCT05055830. Registered on September 24, 2021.
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