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Activity Number: 412 - Incorporation of Real-World Evidence in Clinical Trial Designs and Associated Statistical Methodologies
Type: Topic Contributed
Date/Time: Wednesday, August 5, 2020 : 1:00 PM to 2:50 PM
Sponsor: Section for Statistical Programmers and Analysts
Abstract #313747
Title: Leverage Real World Evidence in Drug Development and Regulatory Decision Making
Author(s): Rongmei Zhang*
Companies: FDA, Center for Drug Evaluation and Research (CDER).
Keywords: real word data; real word evidence; drug development; external control

Real word data (RWD) and real world evidence (RWE) are playing an increasing role in drug development and regulatory decision makings. External controls (or synthetic controls) are a possible type of control arm in an adequate and well-controlled study as discussed in ICH E10. Recently, this type of control has gained enormous attention in drug development, especially for rare disease and oncology. This talk will discuss the challenges of using external control and provide insight of study design and statistical method into the use of external control from our experiences of using RWD in post-market comparative effectiveness studies.

Authors who are presenting talks have a * after their name.

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