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Wednesday, June 27 • 10:00am - 10:30am
#328: Getting the Questions Right

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Component Type: Session
Level: Basic
CE: IACET 0.50

Seating is limited
Randomized clinical trials are often considered the gold standard in drug development to assess efficacy and safety of a new treatment as they are expected to be free from baseline confounding. However, randomisation does not protect from bias due to events that occur after randomisation, e.g. discontinuation of treatment, treatment switching etc. At present, these post-randomisation events are dealt with implicitly as a consequence of choices made about the data collection and statistical analysis. In this content hub, we would like to engage with peers and discuss some of the issues and key solutions to improve transparency and ensure alignment between trial objectives and statistical approaches in clinical trials. We will also present what the DIA Communities are doing to address this topic.

Learning Objectives

Describe some of the challenges in the analysis and interpretation of clinical trial results; Discuss how to improve transparency and ensure alignment between trial objectives and statistical approaches in clinical trials.

Chair

Yeh-Fong Chen, PhD


Speakers
avatar for Yeh-Fong Chen

Yeh-Fong Chen

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Dr. Yeh-Fong Chen is the statistical team leader supporting the Division of Gastroenterology and Inborn Errors Products at the Division of Biometrics III at US Food and Drug Association. She joined FDA in 2000 immediately after graduation with a PhD degree in Statistics from the University... Read More →


Wednesday June 27, 2018 10:00am - 10:30am
Content Hub NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA