Introduction

This chapter considers the design and interpretation of controlled clinical trials of the kind ordinarily relied upon by the United States Government's Food and Drug Administration to evaluate the effectiveness of new drug products. Similar trials are used by other national and supranational drug regulatory agencies such as the Committee on Safety of Medicines in the United Kingdom and the European Agency for the Evaluation of Medicinal Products ( eMeA).

Clinical investigations of the kind considered are almost always carried out by, or at the behest of, commercial drug developers. Although these investigations may have many different goals and aims, they are, above all else, intended to establish that the drug product being evaluated is 'effective in use' within the meaning of the regulatory laws that apply in the jurisdictions in which the sponsor seeks to market the product.

The requirements of drug regulatory law prevailing within a given jurisdiction, therefore, dictate the design of clinical drug trials. An understanding of the design of drug regulatory trials, accordingly, requires familiarity with the specific requirements of the regulatory laws, and their purpose.

This chapter focuses almost exclusively upon United States domestic drug regulatory laws, and their implementation. Fortunately, the theory and practice of drug product regulation has become increasingly 'harmonized' throughout much of the developed world.(1) Accordingly, many of the lessons from the American drug regulatory experience have value elsewhere.

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