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#711: Role of External Data in Confirmatory Clinical Trial: Current Landscape and Future Perspectives
Thursday June 18, 2026 8:00am - 9:00am EDT
116
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-651-L04-P; CME 1.00; RN 1.00

The session explores the integration of external data in clinical trials to enhance efficiency, reduce sample sizes, and shorten timelines. It covers methodological advances, regulatory perspectives, and best practices for using external controls.

Learning Objectives

Identify the nuances while integrating external data in trial design and analysis; Evaluate regulatory requirements and perspectives; Discuss the possibility of external control trial in their organization.

Chair

Satrajit Roychoudhury, PHD

Speaker

Panelist
Xiaofei Wang, PHD

Panelist
Scott Berry, PHD

Panelist
Kannan Natarajan, PHD

Panelist
Pralay Mukhopadhyay, PHD


Speakers
avatar for Scott Berry

Scott Berry

President and Senior Statistical Scientist, Berry Consultants LLC, United States
Scott Berry is President and a Senior Statistical Scientist at Berry Consultants, LLC. He earned his MS and PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. His primary interests... Read More →
PM

Pralay Mukhopadhyay

Vice President, Medicines Development Leader, Oncology R&D, GSK, United States
Dr. Mukhopadhyay has a proven track record in oncology drug development. He currently works as Vice President, Medicine Development Leader at GlaxoSmithKline. Over the years, he has made significant contributions in the development of several anti-cancer agents in both hematologic... Read More →
avatar for Kannan Natarajan

Kannan Natarajan

Senior Vice President, Head of Global Biometrics and Data Management, Pfizer, Inc., United States
Kannan Natarajan is the Global Head of Biometrics & Data Management and Chief Statistical Officer of Global Product Development at Pfizer. He is a member of the Global Product Development Leadership Team and Deputy Chair of the Clinical Development Board, a governance body that provides... Read More →
avatar for Satrajit Roychoudhury

Satrajit Roychoudhury

Executive Director, Statistical Research and Innovation, Pfizer, United States
Dr. Satrajit Roychoudhury is an Executive Director and the head of Statistical Research and Innovation group in Pfizer Inc. Prior to joining, he was a member of Statistical Methodology and Consulting group at Novartis. His primary expertise includes implementation of innovative statistical... Read More →
XW

Xiaofei Wang

Professor, Biostatistics & Bioinformatics, Duke University Medical Center, United States
Xiaofei Wang is Professor of Biostatistics and Bioinformatics at Duke University School of Medicine and Director of Statistics at the Alliance Statistics and Data Management Center. He received his Ph.D. in Biostatistics from the University of North Carolina at Chapel Hill in 2003... Read More →
Thursday June 18, 2026 8:00am - 9:00am EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Forum |   02: ClinicalTrialOps-Innovation, Forum
  • Audience Intermediate
  • Area Evidence Innovation
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations
  • Feature Topics Evidence Innovation
  • Tags Forum

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