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Activity Number: 298 - Confirmatory Adaptive Designs in Action: Recent Advances in Statistical Frameworks and Operational Models
Type: Topic Contributed
Date/Time: Wednesday, August 5, 2020 : 10:00 AM to 11:50 AM
Sponsor: Biopharmaceutical Section
Abstract #313044
Title: Adaptive Borrowing of Historical Data in Clinical Trials
Author(s): John Zhong* and Peng Sun and Charlie Cao and Ming-Hui Chen and Bo Lu and Yingying Liu and Richard Foster and Susie Sinks and Fan Wu and Giulia Gambino
Companies: REGENXBIO and Biogen and Biogen and UNIVERSITY OF CONNECTICUT and The Ohio State University and Biogen and Biogen and Biogen and Biogen and Biogen
Keywords: adaptive ; clinical trials; historical data ; borrowing; matching; rare diseases
Abstract:

The use of historical data to serve or augment a control group in clinical trials has provided a great benefit for drug development, especially in the setting of rare disease and gene therapy to address feasibility and ethical issues. The requirement of similarity between the historical control and concurrent treatment populations is an important consideration; and it may also pose a challenge to ensure adequate power of the study.

In this presentation, we will discuss adaptive approaches to borrow historical data with a possibility of increasing enrollment of patients in the concurrent control group, based on the interim assessment of population similarity and in some situations, the consistence of responses between the historical and concurrent controls. Different matching designs will be explored and simulation studies will be carried out to examine design operational characteristics.


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

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