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evidenceinthewild/README.md

Lu (Maggie) Qian, MS

Biostatistician | Clinical Trial Designer | Founder of Evidence in the Wild & Zetyra

LinkedIn X Email

I build statistical design tools and provide consulting services for clinical trials, specializing in oncology and adaptive designs.

About

I spent nearly a decade as a biostatistician at Fred Hutchinson Cancer Center and SWOG, specializing in oncology trial design and Phase II adaptive designs.

During that time, I identified recurring failure patterns: protocols locked in before anyone stress-tested the assumptions, interim decisions made on gut instead of simulation, sample sizes calculated once and never revisited. I call these "Zombie Trials"—studies continuing enrollment after mathematical evidence suggested stopping.

I founded Evidence in the Wild and Zetyra on the belief that the most expensive experiment is the one that was doomed from the start.

What drives my work:

  • Building Zetyra: the tool I wished I had, combining rigorous validated methods with a modern interface that doesn't require a PhD to operate
  • Providing honest consulting through Evidence in the Wild on trial design before teams invest millions
  • Democratizing statistical tools traditionally locked behind $5,000-$15,000/year enterprise paywalls

Beyond work, I train for Ironman and marathon competitions. Pacing matters in both athletics and trial design.

Core Philosophy:

  • Web-First: Browser-based, shareable designs without installation barriers
  • Collaborative: Project-based workflow with scenario comparison and professional reporting
  • Transparent: Visible methodology using industry-standard, peer-reviewed packages (gsDesign, SciPy)

Evidence in the Wild

Evidence in the Wild provides specialized consulting services for clinical trial statistical design.

Services

Protocol Statistical Review

  • Evaluate draft protocols to identify design flaws before expensive development phases
  • Review sample size assumptions, endpoint selection, and interim analysis strategies
  • Typical turnaround: 1-2 weeks

Sample Size & Power Consultation

  • Justified sample sizing for grants, protocols, and regulatory submissions
  • Covariate adjustment strategies (CUPED, ANCOVA)
  • Adaptive design feasibility assessment
  • Simulation-based operating characteristics

Adaptive Design Feasibility

  • Honest assessment of whether adaptive designs warrant operational complexity
  • Statistical efficiency tradeoff analysis
  • Implementation roadmap for complex designs

Interim Analysis & Futility Planning

  • Design interim looks and stopping rules before trial launch
  • Bayesian predictive power calculations
  • Alpha spending frameworks (O'Brien-Fleming, Pocock)
  • Futility boundary design

Who I Work With

  • Early-stage biotech (Series A/B) needing statistical design expertise
  • Academic investigators pursuing R01 grants or cooperative group proposals
  • CROs requiring independent statistical review
  • Medical device companies building biometrics infrastructure

What I Don't Do

I focus on high-level trial design. I don't provide hourly SAS programming, data cleaning services, or tutoring.

Learn more about consulting services

Zetyra

DOI

Zetyra is a web-based statistical software platform democratizing efficient clinical trial design.

Phase III oncology trials average $50-100M and take 4-6 years to complete. Conservative design practices inflate costs by ignoring baseline correlations, using fixed-sample designs without interim monitoring, and applying frequentist methods for early-stage decisions. Traditional tools (PASS, nQuery) cost $5,000-$15,000/year per seat with no validation transparency.

Core Methodologies:

CUPED - 15-35% sample size reduction using baseline-outcome correlations (FDA-endorsed)

Group Sequential Design - 15-40% expected sample size reduction with interim monitoring (validated against gsDesign R package)

Bayesian Predictive Power - Quantitative go/no-go decisions using interim data (aligns with FDA draft guidance)

Features: Free tier with all calculators, project management, PDF export, 51 automated tests, transparent validation

Try Zetyra | Read the Whitepaper


Building tools and providing expertise to make rigorous statistical design accessible to everyone running clinical trials.

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