Christy Chuang-Stein

Achim Guettner1
Brenda Crowe1
Ian Hirsch1
1Achim Guettner
1Brenda Crowe
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Attrition is a ubiquitous problem in randomized controlled clinical trials (RCT) of psychotropic agents that can cause biased estimates of the treatment effect, reduce statistical power, and restrict the generalizability of results. The extent of the problem of attrition in central nervous system (CNS) trials is considered here and its consequences are(More)
It is frequently noted that an initial clinical trial finding was not reproduced in a later trial. This is often met with some surprise. Yet, there is a relatively straightforward reason partially responsible for this observation. In this article, we examine this reason by first reviewing some findings in a recent publication in the Journal of the American(More)
In March 2011, a Final Rule for expedited reporting of serious adverse events took effect in the United States for studies conducted under an Investigational New Drug (IND) application. In December 2012, the U.S. Food and Drug Administration (FDA) promulgated a final Guidance describing the operationalization of this Final Rule. The Rule and Guidance(More)
The minimum clinically important difference (MCID) between treatments is recognized as a key concept in the design and interpretation of results from a clinical trial. Yet even assuming such a difference can be derived, it is not necessarily clear how it should be used. In this paper, we consider three possible roles for the MCID. They are: (1) using the(More)
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