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Monday, June 25 • 11:00am - 12:15pm
#121: Use of Historical Information in Clinical Trial Design

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-533-L04-P; CME 1.25; IACET 1.25; RN 1.25

The use of historical controls in clinical trials may be an alternative method to assess the efficacy of a new drug. Challenges that arise from the use of historical controls, as well as methods for overcoming those challenges, will be discussed.

Learning Objectives

Determine whether the use of a historical control is Determine whether the use of a historical control is appropriate for their clinical trial design; Discuss how to analyze endpoints and interpret results from clinical trials that use a historical control.

Chair

Sara Jimenez, PhD

Speaker

Efforts to Combine Data Across Companies
Edward Bowen

Using Historical Data to Transform Clinical Trials: Statistical Considerations
Jessica Lim, MA

Converging Lines of Evidence: Using Modern Structural Meta-analysis to Advance Multisite Knowledge Discovery - A Case Study
Andrew Wilson, PhD, MS



Speakers
avatar for Edward Bowen

Edward Bowen

Lead, Placebo as Standard of Care Workstream, Transcelerate Biopharma
Ed Bowen is the Head of R&D Data Science at GSK, where he leads a team of data scientists and machine learning engineers in leveraging large-scale, distributed systems in building, testing and validating analytics, statistical models, and machine learning models. These models and... Read More →
avatar for Sara Jimenez

Sara Jimenez

Mathematical Statistician, OB, OTS, CDER, FDA
Sara Jimenez is a mathematical statistician in the Division of Gastroenterology and Inborn Errors Products at the FDA’s Center for Drug Evaluation and Research. She performs regulatory reviews of clinical trial submissions and contributes to data standards efforts within the division... Read More →
avatar for Jessica Lim

Jessica Lim

Director, Clinical Statistics, GlaxoSmithKline
Jessica Lim leads a team of HIV clinical statisticians at GSK. She is also the Scientific Application subteam lead on the TransCelerate Placebo/Standard of Care data sharing initiative. Jessica received her MA in Biostatistics from UC Berkeley and has experience in the pharmaceutical... Read More →
avatar for Andrew Wilson

Andrew Wilson

Director, Pharmacoepidemiology and Statistics RWDS, PAREXEL
I lead the pharmacoepidemiology & statistics initiatives within Real World Data Services at PAREXEL. To be part of the real world evidence movement, it is essential we embrace the data generation process, and keep data context as all-important. Real world data typically comes from... Read More →


Monday June 25, 2018 11:00am - 12:15pm
Room 256 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA