The Development and Assessment of New Cytotoxic Drugs

Abstract

In the early days of cancer chemotherapy compounds which showed promising antitumour effects in the laboratory were rapidly given to patients with a minimum of preclinical testing. The subsequent clinical evaluation of toxicity and efficacy was often crude and superficial by today’s standards. Stimulated by events such as the thalidomide tragedy, increasing statutory controls on new drug development were introduced during the 1950s and 1960s. During the same period the principles of clinical assessment became more clearly defined and a relatively uniform pattern of evaluation has emerged.