Abstract
Interruption of active drug treatment in clinical trials can be classified broadly as therapeutic treatment interruption (TI), in which the potential therapeutic benefit of supervised interruption of treatment is investigated, and analytic TI, in which participants are randomized to stopping versus continuing active treatment; the TI arm serves as control group. Design issues for therapeutic TI trials are discussed in the example of a trial in HIV/AIDS. Analytic TIs are used in therapeutic HIV vaccine trials, in randomized discontinuation designs, and in other situations. The use of a randomized discontinuation design for a Phase II drug trial in cancer is discussed.
| Original language | English (US) |
|---|---|
| Title of host publication | Wiley Encyclopedia of Clinical Trials |
| Publisher | Wiley |
| Pages | 1-12 |
| Number of pages | 12 |
| ISBN (Electronic) | 9780471462422 |
| ISBN (Print) | 9780471352037 |
| DOIs | |
| State | Published - Jan 1 2007 |
Bibliographical note
Publisher Copyright:© 2007 by John Wiley & Sons, Inc.
Keywords
- analytic treatment interruption
- enrichment design
- intermittent therapy
- randomized discontinuation design
- therapeutic treatment interruption
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