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Activity Number: 500 - Beyond Randomized Studies: Nonrandomized, Single Arm, or Special Studies
Type: Topic Contributed
Date/Time: Wednesday, August 2, 2017 : 10:30 AM to 12:20 PM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #324365 View Presentation
Title: Design and Analysis of Single Arm Clinical Trials Involving Highly Heterogeneous Subjects
Author(s): Sherry Liu*
Companies: FDA
Keywords: single arm ; survival ; hetorogeneity
Abstract:

The intent-to-treat (ITT) population of a new therapy usually consists of patients of highly diversified biological profiles defined by multiple covariates such as race, age and specific disease characteristics. These patients may have significantly different response to the same treatment. A properly designed validation study for a newly developed therapy should be able to cover the complete spectrum of the ITT population and enable precise estimates for the distribution of the clinical outcomes. In this talk, we will discuss the statistical methods that can be used for modeling data collected from subjects of high heterogeneity. The methods will be demonstrated using examples of single arm clinical trials involving analyses of response rates and survival time data.


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

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