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Virtual

Mar 29, 2023 10:00 AM - Mar 31, 2023 4:15 PM

(US Eastern Standard Time)

DIA/FDA Biostatistics Industry and Regulator Forum

Join us virtually from the comfort of your home/office March 29-31 or watch later at a time that works for you. This event provides access to the materials for a full two months!

Session 9: Design Considerations in Using RWE/RWD in Clinical Trials

Session Chair(s)

Shanti V Gomatam, PhD, MS, MSc

Shanti V Gomatam, PhD, MS, MSc

Mathematical Statistician

FDA, United States

Venkat  Sethuraman, PhD, MBA, MS

Venkat Sethuraman, PhD, MBA, MS

Senior Vice President, Global Biometrics and Data Sciences

Bristol Myers Squibb, United States

As the regulatory and health technology landscape is constantly adapting to the needs and demands of accelerating medicines to market, real-world data (RWD) and real-world evidence (RWE) are becoming increasingly important tools for decision-making. Historically, these approaches were utilized heavily in the post-marketing or safety surveillance settings. currently, we observe increasing adoption within clinical development and regulatory decision making. In this session, we will share RWE/RWD guidance framework from health authorities along with examples where RWD and RWE have been utilized in regulatory decision making, including innovative approaches explored by sponsors and future areas for research.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Identify guidances that discuss RWE/RWD in the regulatory setting
  • Recognize statistical methods leveraged in the analysis of RWD
  • List some examples where RWD/RWE have been used in regulatory submissions
  • Describe innovative approaches of combining RWD and clinical trial data in decision making

Speaker(s)

Pallavi  Mishra-Kalyani, PhD, MS

Guidance for RWD/RWE use in Regulatory Submissions

Pallavi Mishra-Kalyani, PhD, MS

FDA, United States

Deputy Division Director, DBV, OB, CDER

David  Paulucci, MSc

Emulating Randomized Controlled Trials with Hybrid Control Arms in Oncology: A Case Study

David Paulucci, MSc

BMS, United States

Director, Data Science

Jian  Zhao, PhD

An Example of RWD/RWE use in the Regulatory Context

Jian Zhao, PhD

FDA, United States

Mathematical Statistciain

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