Strategy and planning for chemopreventive drug development: Clinical development plans

Gary J. Kelloff, James A. Crowell, Charles W. Boone, Vernon E. Steele, Ronald A. Lubet, Peter Greenwald, David S. Alberts, Joseph M. Covey, Linda A. Doody, Gene G. Knapp, Susan Nayfield, David R. Parkinson, V. K. Prasad, Phillip C. Prorok, Edward A. Sausville, Caroline C. Sigman

Research output: Contribution to journalArticle

31 Scopus citations

Abstract

At the National Cancer Institute, Division of Cancer Prevention and Control, the Chemoprevention Branch and Agent Development Committee develop strategies for efficiently identifying, procuring, and advancing the most promising drugs into clinical trials. Scientific expertise is applied at each phase of development to critically review the testing methods and results, and to establish and apply criteria for evaluating the agents for further development. The Clinical Development Plan, prepared by the Chemoprevention Branch and the Agent Development Committee, is a summary of the status of the agent regarding evidence for safety and chemopreventive efficacy in preclinical and clinical studies. It also contains the strategy for further development of the drug that addresses pharmacodynamics, drug effect measurements, intermediate biomarkers for monitoring efficacy, toxicity, supply and formulation, regulatory approval, and proposed clinical trials. Sixteen Clinical Development Plans are presented here: N‐acetyl‐l‐cysteine (NAC), aspirin, calcium, β‐carotene, 2‐difluoromethylornithine (DFMO), DHEA analog 8354, 18β‐glycyrrhetinic acid, N‐(4‐hydroxyphenyl)retinamide (4‐HPR), ibuprofen, oltipraz, piroxicam, Proscar®, sulindac, tamoxifen, vitamin D3 and analogs and vitamin E. The objective of publishing these plans is to stimulate interest and thinking among the scientific community on the prospects for developing chemopreventive drugs. 1994 Wiley‐Liss, Inc.

Original languageEnglish (US)
Pages (from-to)55-62
Number of pages8
JournalJournal of Cellular Biochemistry
Volume56
Issue number20 S
DOIs
StatePublished - 1994

ASJC Scopus subject areas

  • Biochemistry
  • Molecular Biology
  • Cell Biology

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    Kelloff, G. J., Crowell, J. A., Boone, C. W., Steele, V. E., Lubet, R. A., Greenwald, P., Alberts, D. S., Covey, J. M., Doody, L. A., Knapp, G. G., Nayfield, S., Parkinson, D. R., Prasad, V. K., Prorok, P. C., Sausville, E. A., & Sigman, C. C. (1994). Strategy and planning for chemopreventive drug development: Clinical development plans. Journal of Cellular Biochemistry, 56(20 S), 55-62. https://doi.org/10.1002/jcb.240560906