Projects in Development
Research initiatives currently in the planning and development phase, representing WIRE's future directions in trial methodology, clinical trials, and research infrastructure.
RENEW: Embedded Platform Trial Feasibility Study
PI: Zachary L. Smith, DO, MSc
RENEW is a prospective, single-center feasibility trial designed to evaluate whether MyChart-based recruitment, remote e-consent, and real-time nurse-triggered randomization inside Epic can be successfully integrated into routine colonoscopy workflow. The study mimics the structure of a multi-domain platform trial to test the operational capabilities required to conduct pragmatic, embedded clinical trials in GI endoscopy — serving as an essential precursor to larger platform trials in the field.
- Platform trial design
- Epic-embedded randomization
- MyChart recruitment
- Remote e-consent feasibility
RESUME: Resumption of Anticoagulation After Endoscopy
PI: Zachary L. Smith, DO, MSc
RESUME is a large, multicenter, randomized, comparative effectiveness study investigating the optimal timing for resuming direct oral anticoagulants (DOACs) after high-risk gastrointestinal endoscopy. The trial addresses a critical evidence gap — balancing the risk of delayed GI bleeding against the risk of thromboembolic events — in a growing population of patients on DOACs who require endoscopic procedures. RESUME employs a stakeholder-informed hierarchical composite endpoint and will generate the first large-scale comparative effectiveness data to guide periendoscopic DOAC management.
- Multicenter RCT
- DOAC management
- Hierarchical composite endpoint
- Stakeholder-informed design
CORE: Core Outcomes for Research in Endoscopy
PI: Zachary L. Smith, DO, MSc
CORE is a methodological research program to modernize evidence generation in GI endoscopy by establishing standardized, stakeholder-informed frameworks for clinical trials. The program develops multi-stakeholder Core Outcome Sets for priority endoscopy domains, creates validated hierarchical composite endpoints, and builds analytic frameworks that address operator- and site-level variability. By defining what outcomes should be measured, how they should be prioritized, and how procedural variability should be addressed, CORE aims to improve rigor, interpretability, and generalizability across the field.
- Core Outcome Sets
- Stakeholder engagement
- Hierarchical composite endpoints
- Operator-aware analytics