The design of clinical trials in psoriasis: lessons for clinical practice☆

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Abstract

Understanding the process by which drugs are approved gives clinicians a better understanding of the medications they prescribe and how these medications are best used to care for patients. The development of new drugs in the United States proceeds through a series of studies culminating in well-designed, large-scale human trials. These studies result from a coordinated collaboration between industry and the Food and Drug Administration (FDA). The results of these studies determine whether drugs are approved for use or not. They also determine the labeling and marketing of products and guide (but do not fully determine) physicians’ use of the drug. This article follows a hypothetical drug for use in psoriasis through the approval process, in order to illustrate the process and its implications for clinical practice.

Section snippets

Consider a hypothetical example

Let’s consider the development of a purely hypothetical new drug, which we shall call “Ipotet.” Ipotet is an immune inhibitor that has completed preclinical testing that showed, in animal models, promise in the treatment of psoriasis as well as basic safety characteristics. In Phase I testing in humans, an optimal dose and tolerance was determined. Phase II testing in 60 patients compared the efficacy and safety of the drug to those of placebo.

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Summary

The discussion of Ipotet is not intended to reflect the approval process of any one particular agent, but rather to illustrate general principles relevant to clinical trials of any new agent for psoriasis. Clinical trials are designed and undertaken to get drugs approved, and the information they generate guides clinical practice. Drug trials are far more structured than is clinical practice, however. Drugs are tested as monotherapies in relatively homogeneous populations. This gives a high

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Disclosure: Dr Feldman has received grant support from and/or has served as a consultant to Roche Dermatology, Biogen, Centocor, Amgen, Genentech, and Galderma.

Funding sources: None.

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Copyright © 2003 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.