| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 6151321 | Contemporary Clinical Trials | 2013 | 13 Pages |
Abstract
Biomarker-guided personalized therapies offer great promise to improve drug development and improve patient care, but also pose difficult challenges in designing clinical trials for the development and validation of these therapies. We first give a review of the existing approaches, briefly for clinical trials in new drug development and in more detail for comparative effectiveness trials involving approved treatments. We then introduce new group sequential designs to develop and test personalized treatment strategies involving approved treatments.
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Authors
Tze Leung Lai, Olivia Yueh-Wen Liao, Dong Woo Kim,