1. Clinical Trial Design with Targeted Agents.
- Author
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Teicher, Beverly A., Kaufman, Howard L., Wadler, Scott, Antman, Karen, Dubey, Sarita, and Schiller, Joan H.
- Abstract
Targeted agents differ from cytotoxic chemotherapy in their mechanism of action and clinical outcomes. Similarly, drug development for targeted agents may also differ. Targeted agents are generally better tolerated than chemotherapeutic agents and may have activity at doses lower than maximum tolerated dose (MTD). Optimum drug dosing needs to be based not only on toxicities but also on pharmacokinetic and pharmacodynamic parameters. As cytostatic-targeted agents may induce disease stabilization, time to progression and survival may be a more appropriate outcome of interest than disease regression. Translational research becomes an indispensable part of trials with targeted agents to identify optimum dosing and to identify predictive biomarkers. This includes advances in technology, better understanding of tumor biology, and validation of research techniques. Clinical trials with novel randomization designs have been developed in recent years to optimize identification of drug activity in a targeted population. [ABSTRACT FROM AUTHOR]
- Published
- 2008
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