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 pragmatic, multicenter, two-stage adaptive randomized trial comparing resumption of direct oral anticoagulants (DOACs) on postoperative day 1, 2, or 5 after high-risk gastrointestinal endoscopy. It addresses an evidence gap that every major guideline acknowledges: balancing delayed GI bleeding against thromboembolic events in the growing population of patients on DOACs who need endoscopic procedures. The primary outcome is 30-day clinically significant GI bleeding, and the key secondary outcome is 90-day ischemic stroke or systemic embolism. RESUME has been submitted to NHLBI as a UG3/UH3 Clinical Coordinating Center application, with a companion Data Coordinating Center at Northwestern University, and to the Canadian Institutes of Health Research (CIHR); it is under review at both.
- Multicenter adaptive RCT
- DOAC resumption timing
- 5,420 participants, 23 U.S. sites
- Under review at NHLBI (UG3/UH3) and CIHR
ADAPT: Advancing Design and Analysis for Procedural Trials
PI: Zachary L. Smith, DO, MSc
ADAPT is a methodological research program to modernize evidence generation in GI endoscopy. Trials in the field often measure different outcomes, define them inconsistently, and rarely reflect what patients value. ADAPT addresses this in three aims. The first, CORE (Core Outcomes for Research in Endoscopy), develops multi-stakeholder Core Outcome Sets for endoscopic resection of advanced colorectal polyps and endoscopic eradication therapy for Barrett's esophagus. The second builds stakeholder-informed hierarchical composite endpoints from those outcome sets. The third develops analytic frameworks that account for operator- and site-level variability. ADAPT is being prepared as an NIDDK R01 submission for February 2027.
- Core Outcome Sets (CORE)
- Stakeholder engagement
- Hierarchical composite endpoints
- Operator-aware analytics
- NIDDK R01 in preparation
CONTEND: Continuing or Ending Surveillance of Small, Stable Pancreatic Cysts in Older Adults
PI: Zachary L. Smith, DO, MSc
Many older adults with a small pancreatic cyst that has not changed in years remain in imaging surveillance indefinitely, and guidelines disagree on when it should stop. CONTEND is a pragmatic randomized trial that will compare stopping with continuing surveillance in adults aged 70 or older whose small, presumed branch-duct IPMN has been stable for at least five years. The trial will run inside routine care through PCORnet, with no research visits, and capture outcomes from health records, claims, and registries. Its co-primary outcomes weigh the benefits and harms of surveillance with a patient-ranked hierarchical composite endpoint and test whether stopping is non-inferior for pancreatic cancer. CONTEND is being developed for PCORI's Broad Pragmatic Studies program.
- Pragmatic randomized trial
- Embedded in PCORnet
- Hierarchical composite endpoint
- Surveillance de-escalation
- PCORI application in development