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Phase 1 clinical trials.

Authors
Type
Published Article
Journal
Journal of cutaneous medicine and surgery
Publication Date
Volume
2
Issue
4
Pages
236–241
Identifiers
PMID: 9558307
Source
Medline

Abstract

Phase 1 trials are primarily designed to accumulate short-term safety (toxicity) and pharmacological data. Although preliminary efficacy may be addressed ("proof of concept" efficacy), it is a secondary endpoint. The numbers of patients are small, the numbers of patients receiving efficacious doses are very small, and controls are absent. Evaluation of efficacy and of long-term toxicity requires longer, larger, and controlled studies.

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