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Session 9: Design Considerations in Using RWE/RWD in Clinical Trials
Session Chair(s)
Shanti V Gomatam, PhD, MS, MSc
Mathematical Statistician
FDA, United States
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)
Guidance for RWD/RWE use in Regulatory Submissions
Pallavi Mishra-Kalyani, PhD, MS
FDA, United States
Deputy Division Director, DBV, OB, CDER
Emulating Randomized Controlled Trials with Hybrid Control Arms in Oncology: A Case Study
David Paulucci, MSc
BMS, United States
Director, Data Science
An Example of RWD/RWE use in the Regulatory Context
Jian Zhao, PhD
FDA, United States
Mathematical Statistciain
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