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Wednesday June 17, 2026 1:45pm - 2:45pm EDT
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-614-L04-P; CME 1.00; RN 1.00

Panelists that conduct trial emulation with real-world data to design better trials will present work from oncology and COPD/asthma. Presentations followed by discussion on data-driven trial design and its challenges.

Learning Objectives

Explain how trial emulation using real-world data can be used to enhance design of future clinical trials; Discuss the need for clinical trials design to take a data-driven approach and how this can lead to larger patient pools and trials that are more generalizable to clinical practice; Discuss the challenges of emulating trial endpoints, eligibility criteria, and other design elements.

Chair

Leo Russo, MS

Speaker

Panelist
Jingchuan Serena Guo, MD, PHD

Panelist
Donna Rivera, PHARMD, MSC, FISPE


Speakers
JS

Jingchuan Serena Guo

Associate Professor, Purdue University, United States
avatar for Donna Rivera

Donna Rivera

Executive Vice President-Clinical Evidence Modernization, Canal Row Advisors, United States
Donna R. Rivera, PharmD., MSc., FISPE is the Associate Director for Pharmacoepidemiology in the Oncology Center of Excellence at the U.S. Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the regulatory review of Real World Data (RWD... Read More →
avatar for Leo Russo

Leo Russo

Advisor, Get Real Institute, United States
I bridge the gap between clinical trials and real-world outcomes, ensuring breakthrough therapies deliver on their promise to patients. Leading teams across pharmaceutical development for 25+ years, I've pioneered trial emulation, AI analytics, and pragmatic designs that generate... Read More →
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Forum |   10: Stats-EvidenceGeneration-RWE, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Biostatistics
  • Tags Forum

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