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Articles by Christy Chuang-Stein
Total Records ( 2 ) for Christy Chuang-Stein
  Paul Gallo , Keaven Anderson , Christy Chuang-Stein , Vladimir Dragalin , Brenda Gaydos , Michael Krams and Jose Pinheiro
  The US Food and Drug Administration has recently released a draft guidance document on adaptive clinical trials. We comment on the document from the particular perspective of the authors as members of a PhRMA working group on this topic, which has interacted with FDA personnel on adaptive trial issue during recent years. We describe the activities and prior work of our working group, and use this as a basis to discuss the content of the guidance document as it relates to several issues of current relevance, such as data monitoring processes, adaptive dose finding, so-called seamless trial designs, and sample size reestimation.
  Christy Chuang-Stein and Mohan Beltangady
  The Food and Drug Administration of the United States issued a draft guidance on adaptive design clinical trials in February 2010. This draft guidance has attracted a lot of attention because of the increasing interest in adaptive trials by the pharmaceutical industry in recent years. In this paper, we report on highlights of comments collected within Pfizer on this draft guidance. In addition, we share Pfizer’s internal journey to promote efficient trial designs since 2005. Adaptive designs have been part of that journey.
 
 
 
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