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Previous Volume 344:762-763 March 8, 2001 Number 10 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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New therapies require rigorous evaluation before they become part of routine clinical care. The process of evaluating new drugs and devices is well established. When a new approach to treatment is ready for human trials, a phase 1 study is conducted with small numbers of patients so that common treatment-related toxic effects can be identified rapidly. Armed with an understanding of the types of problems that may accompany the new therapeutic approach, investigators conduct a phase 2 study, usually involving many more patients, to assess the potential therapeutic efficacy. Only after the technical feasibility is established, common toxic effects are . . . [Full Text of this Article]

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