Presented at the 34th Annual Scientific Meeting of the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists, Newcastle, 3–6 December 2000.
Design Of Clinical Pharmacology Trials
Article first published online: 12 JAN 2002
Clinical and Experimental Pharmacology and Physiology
Volume 28, Issue 11, pages 905–912, November 2001
How to Cite
Duffull, S. B. (2001), Design Of Clinical Pharmacology Trials. Clinical and Experimental Pharmacology and Physiology, 28: 905–912. doi: 10.1046/j.1440-1681.2001.03546.x
- Issue published online: 12 JAN 2002
- Article first published online: 12 JAN 2002
- cross-over design;
- Monte Carlo simulation;
- optimal design;
- population analysis
1. There are a variety of methods that could be used to increase the efficiency of the design of experiments. However, it is only recently that such methods have been considered in the design of clinical pharmacology trials.
2. Two such methods, termed data-dependent (e.g. simulation) and data-independent (e.g. analytical evaluation of the information in a particular design), are becoming increasingly used as efficient methods for designing clinical trials. These two design methods have tended to be viewed as competitive, although a complementary role in design is proposed here.
3. The impetus for the use of these two methods has been the need for a more fully integrated approach to the drug development process that specifically allows for sequential development (i.e. where the results of early phase studies influence later-phase studies).
4. The present article briefly presents the background and theory that underpins both the data-dependent and -independent methods with the use of illustrative examples from the literature. In addition, the potential advantages and disadvantages of each method are discussed.