Principal Investigator: Disha Subramaniam, PhD Student / Digestive Disease Pre-doctoral Fellow, University of North Carolina at Chapel Hill
Purpose:
This work will be the first to evaluate multiple approaches to addressing missing outcome data in an external control arm for pediatric Crohn's disease, ultimately aiming inform innovations in pediatric IBD trials to get much-needed
treatments to children who need them.
Aims:
- Aim 1: To describe and visualize patterns of key variable missingness in the component categories of the Pediatric Crohn's Disease Activity Index (PCDAI) in a cohort constructed from real-world registry data to serve as an external control to the treatment arm of a prior randomized trial in pediatric Crohn's disease
- Aim 2: To assess the bias and precision of common statistical approaches to handle missing PCDAI component data in a modified pediatric Crohn's disease trial data set that incorporates realistic patterns of key variable missingness based on a matched registry-based external control cohort
Study Start Date: December 15, 2024
Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.
Contact: [email protected]