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A Master Protocol Template for Pediatric ARDS Studies
Andrew G Miller1, Martha Aq Curley2, Claire Destrampe3
1Division of Pediatric Critical Care Medicine, Duke University Medical Center, Durham, North Carolina; and Respiratory Care Services, Duke University Medical Center, Durham, North Carolina. Andrew.g.miller@duke.edu.
Insights
Developing a master protocol template with common data elements (CDEs) can standardize pediatric acute respiratory distress syndrome (ARDS) trials. This approach aims to overcome barriers and facilitate pooled analysis of clinical trial data in children.
Area of Science:
- Pediatric Critical Care Medicine
- Clinical Trial Design
- Respiratory Medicine
Background:
- Pediatric acute respiratory distress syndrome (ARDS) is a serious condition with high morbidity and mortality.
- Clinical trials in pediatric ARDS are limited by design and execution challenges.
- A master protocol approach can address these barriers and support pediatric ARDS research.
Purpose of the Study:
- To collaboratively develop a master protocol template for pediatric ARDS clinical trials.
- To link the master protocol with common data elements (CDEs) for standardization.
- To facilitate the conduct and analysis of future pediatric ARDS studies.
Main Methods:
- Conducted a literature search of pediatric ARDS randomized controlled trials (RCTs).
- Employed a multi-stakeholder, collaborative process to develop a master protocol template.
- Integrated CDEs and electronic case report forms into the master protocol.
Main Results:
- Identified 11 small, heterogeneous RCTs in pediatric ARDS.
- Significant heterogeneity in ARDS definitions, designs, and outcomes was observed.
- A master protocol template was developed with expert input and linked to CDEs.
Conclusions:
- Pediatric ARDS trials are often small and heterogeneous, hindering pooled analysis.
- A standardized master protocol with CDEs can improve comparability and knowledge generation.
- This approach supports combining and comparing findings from future pediatric ARDS trials.
Background:
Pediatric ARDS is associated with significant morbidity and mortality. High-quality data from clinical trials in children are limited due to numerous barriers to their design and execution. Here we describe the collaborative development of a master protocol as a tool to address some of these barriers and support the conduct of pediatric ARDS studies.
Methods:
Using PubMed, we performed a literature search of randomized controlled trials (RCTs) in pediatric ARDS to characterize the current state and evaluate potential benefit of harmonized master protocols. We used a multi-stakeholder, collaborative, and team science-oriented process to develop a master protocol template with links to common data elements (CDEs) for pediatric ARDS trials.
Results:
We identified 11 RCTs that enrolled between 14-200 total subjects per trial. Interventions included mechanical ventilation, prone positioning, corticosteroids, and surfactant. Studies displayed significant heterogeneity in ARDS definition, design, inclusion and exclusion criteria, and reported outcomes. Mortality was reported in 91% of trials and ventilator-free days in 73%. The trial heterogeneity made pooled analysis unfeasible. These findings underscore the need for a method to facilitate combined analysis of future trials through standardization of trial elements. As a potential solution, we developed a master protocol, iteratively revised with input from a multidisciplinary panel of experts and organized into 3 categories: instructions and general information, templated language, and a series of text options of common pediatric ARDS trial scenarios. Finally, we linked master protocol sections to relevant CDEs previously defined for pediatric ARDS and captured in a series of electronic case report forms.
Conclusions:
The majority of pediatric ARDS trials identified were small and heterogeneous in study design and outcome reporting. Using a master protocol template for pediatric ARDS trials with CDEs would support combining and comparing pediatric ARDS trial findings and increase the knowledge base.
