Digital Endpoint Evidence Generation Toolkit
An R-based analytical framework for standardizing validation evidence generation across digital endpoint programs. Designed to scale from single-study analyses to enterprise-wide reuse.
Challenge
Digital endpoint validation requires consistent statistical analyses (known-groups validity, convergent/divergent validity, anchor-based responsiveness, sensitivity-to-change) across studies. Without standardization, each analysis is reinvented, risking inconsistency and slowing timelines.
Approach
- Designed modular R functions aligned to modern DHT validation thinking
- Built reproducible report templates (parameterized RMarkdown)
- Conceptualized Shiny interface for non-programmers
- Defined "valid dataset" specifications upstream of analysis
Impact
Reduced analysis setup time, improved cross-study consistency, enabled knowledge transfer to new team members. Positioned team for future regulatory submissions requiring robust validation evidence.