An analysis of adaptive design variations on the sequential parallel comparison design for clinical trials.

ABSTRACT:

Background

Currently, a growing placebo response rate has been observed in clinical trials for antidepressant drugs, a phenomenon that has made it increasingly difficult to demonstrate efficacy. The sequential parallel comparison design (SPCD) is a clinical trial design that was proposed to address this issue. The SPCD theoretically has the potential to reduce the sample-size requirement for a clinical trial and to simultaneously enrich the study population to be less responsive to the placebo.

Purpose

Because the basic SPCD already reduces the placebo response by removing placebo responders between the first and second phases of a trial, the purpose of this study was to examine whether we can further improve the efficiency of the basic SPCD and whether we can do so when the

SUBMITTER: Mi MY 

PROVIDER: S-EPMC3612388 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature