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Tuesday, June 18 • 8:00am - 9:00am
#213: Beyond Traditional Trials: Real-World Data for External Controls, with Focus on Cancer Drug Applications

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-568-L04-P; CME 1.00; RN 1.00

Advanced cancers pose a dilemma between evidentiary requirements and speedy access to innovative agents. We present the results of a survey with regulators and discuss factors that influence acceptability of real-world data and possible optimal submission strategies.

Learning Objectives

Describe the challenges of drug development with evidence using external controls; Discuss regulators’ attitudes about real-world evidence and opportunities for addressing the challenges; Identify strategies using real-world evidence to maximize impact on the regulatory decision.

Chair

Francesco Pignatti, MD

Speaker

Real-World Data to Support Benefit-Risk Assessment: Regulatory Perspective
Douwe Postmus, PhD, MSc

External Comparators Using Real-World Data: Results of a Simulation Study
Gerd Rippin, DrSc

The Role and Impact of Real-World Data in Cancer Drug Applications
Catherine C. Lerro, PhD, MPH


Speakers
avatar for Catherine Lerro

Catherine Lerro

Senior Pharmacoepidemiologist, Oncology Center of Excellence, FDA, United States
Dr. Lerro is a senior pharmacoepidemiologist in the Oncology Center of Excellence at the US FDA. Prior to joining the FDA, she trained at the National Cancer Institute in the Division of Cancer Epidemiology and Genetics. She holds a doctorate degree and masters in public health from... Read More →
avatar for Francesco Pignatti

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands
Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
avatar for Douwe Postmus

Douwe Postmus

Assistant Professor & Seconded National Expert, University Medical Center Groningen & EMA, Netherlands
Dr Douwe Postmus is employed as an assistant professor at the Department of Epidemiology of the University Medical Center Groningen, The Netherlands. His research focuses on applying quantitative modeling techniques to decision making problems in health care, including regulatory... Read More →
avatar for Gerd Rippin

Gerd Rippin

Senior Director, Biostatistics, Real-World Solutions, IQVIA, Germany
Dr. Gerd Rippin is a trained statistician, receiving his statistics degree in 1995 from the University of Dortmund, Germany (equivalent to BSc and MSc), and his Dr. of Sciences (equivalent to PhD) in 1999 from the University of Mainz, Germany. Dr. Rippin has worked as a medical statistician... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  11: Statistics-Data Science, Session