Clinical Scorecard: The PROMISE Initiative: Developing Reliable Living Evidence for Pediatric Medication Safety through the Trial Bank Project
At a Glance
Category
Detail
Condition
Medication-related harms in pediatric populations
Key Mechanisms
Aggregation and synthesis of randomized controlled trial data using AI-supported Trial Bank infrastructure to assess adverse events
Target Population
Children under 18 years of age receiving pharmaceutical or biopharmaceutical interventions
Care Setting
Clinical research and pediatric medication safety monitoring
Key Highlights
Medication-related harms cause significant global morbidity and mortality, especially in children under 4 years old.
Traditional RCTs and systematic reviews have limitations in providing timely and robust harm data due to low event rates and resource-intensive processes.
The PROMISE project uses AI tools and a continuously updated Trial Bank to improve evidence synthesis and monitoring of pediatric medication safety.
Guideline-Based Recommendations
Diagnosis
Identify medication-related harms through systematic literature search of RCTs involving pediatric populations.
Use standardized definitions of adverse events as any untoward medical occurrence in clinical practice.
Management
Develop living evidence synthesis platforms to rapidly incorporate new trial data for timely decision-making.
Focus on pediatric-specific data given the limited representation of children in clinical trials.
Monitoring & Follow-up
Continuously update Trial Bank with structured trial data using AI-assisted extraction and human verification.
Monitor adverse event outcomes by comparing Trial Bank outputs with established systematic reviews.
Risks
Low reporting rates of trial results limit comprehensive harm assessment.
Potential data quality issues from retracted trials necessitate exclusion to avoid evidence contamination.
Patient & Prescribing Data
Children enrolled in randomized controlled trials of pharmaceutical or biopharmaceutical interventions
Current evidence on medication harms in children is limited; PROMISE aims to improve precision and timeliness of harm estimates to inform safer prescribing.
Clinical Best Practices
Include pediatric populations explicitly in clinical trials to enhance medication safety data.
Utilize AI-supported tools to streamline literature screening and data extraction for evidence synthesis.
Apply rigorous human verification to ensure accuracy of AI-extracted trial data.
Exclude retracted trials to maintain data integrity in safety assessments.
Adopt living systematic review approaches to keep evidence current and relevant.
