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Virtual

09 nov 2020 10:00 a.m. - 10 nov 2020 3:45 p.m.

(US Eastern Standard Time)

Real World Evidence Conference

Session 2: The Selection and Use of External Comparators for Expedited Drug Development

Session Chair(s)

Robert  Reynolds, DrSc, MSc, FISPE

Robert Reynolds, DrSc, MSc, FISPE

Vice President, Epidemiology & Patient-Centered Outcomes, VEO

GSK, United States

Mark  Stewart, PhD

Mark Stewart, PhD

Vice President, Science Policy

Friends of Cancer Research, United States

For certain clinical settings and scenarios, randomized control trials (RCTs) may be unethical or operationally infeasible. The use of real world data/evidence may provide additional context and supplementary evidence to support regulatory decisions and may be warranted due to the rarity of the disease, scarcity of patients, scientific concerns with data interpretability, or ethical considerations. This session will 1) discuss drug development scenarios that may benefit from the use of real world evidence specifically external comparators, also called synthetic, historical or virtual controls, that supplement or augment RCT data; 2) identify perceived barriers to the use and methodological approaches for constructing external comparator arms; and 3) describe use cases and operational considerations.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Identify clinical scenarios and settings where RWD and external comparators are appropriate to support regulatory decision-making
  • Describe methodological approaches for improving the usefulness of RWD to aid in interpreting the safety and efficacy of medicines under development
  • Propose mechanisms to integrate RWD into expediated drug development studies intended for regulatory submission

Speaker(s)

Ruthie  Davi, PhD, MS

Innovative Approaches to External Controls; Synthetic Control Arms

Ruthie Davi, PhD, MS

Medidata, a Dassault Systèmes Company, United States

Vice President, Data Science and Statistician

Jeremy A Rassen, DrSc, MS

Design and Analysis Approaches to Maximize the Validity of ECAs

Jeremy A Rassen, DrSc, MS

Aetion, United States

Co-Founder and President

Zoe  Li, MBA

Building Quality and Traceability into Data Curation

Zoe Li, MBA

COTA, United States

Director, Life Sciences

Christina  Mack, PhD, MPH

Using Comparators for Context: Key Points and Case Examples

Christina Mack, PhD, MPH

IQVIA, United States

Chief Scientific Officer, Real-World Solutions

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