STRATEGY AND PLANNING FOR CHEMOPREVENTIVE DRUG DEVELOPMENT - CLINICALDEVELOPMENT PLANS

At the National Cancer Institute, Division of Cancer Prevention and Co ntrol, the Chemoprevention Branch and Agent Development Committee deve lop strategies for efficiently identifying procuring, and advancing th e most promising drugs into clinical trials. Scientific expertise is a pplied at each phase of development to critically review the testing m ethods and results, and to establish and apply criteria for evaluating the agents for further development. The Clinical Development Man, pre pared by the Chemoprevention Branch and the Agent Development Committe e, is a summary of the status of the agent regarding evidence for safe ty and chemopreventive efficacy in preclinical and clinical studies. I t also contains the strategy for further development of the drug that addresses pharmaco-dynamics, drug effect measurements, intermediate bi omarkers for monitoring efficacy, toxicity, supply and formulation, re gulatory approval, and proposed clinical trials. Sixteen Clinical Deve lopment Plans are presented here: N-acetyl-l-cysteine (NAC), aspirin, calcium, beta-carotene, 2-difluoromethylornithine (DFMO), DHEA analog 8354, 18 beta-glycyrrhetinic acid, N-(4-hydroxyphenyl)retinamide (4-HP R), ibuprofen, oltipraz, piroxicam, Proscar(R), sulindac, tamoxifen, v itamin D-3 and analogs, and vitamin E. The objective of publishing the se plans is to stimulate interest and thinking among the scientific co mmunity on the prospects for developing chemopreventive drugs. (C) 199 4 Wiley-Liss, Inc.