Strategy and planning for chemopreventive drug development: Clinical development plans

G. J. Kelloff, J. A. Crowell, C. W. Boone, V. E. Steele, R. A. Lubet, P. Greenwald, David S Alberts, J. M. Covey, L. A. Doody, G. G. Knapp, S. Nayfield, D. R. Parkinson, V. K. Prasad, P. C. Prorok, E. A. Sausville, C. C. Sigman

Research output: Contribution to journalArticle

31 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)55-299
Number of pages245
JournalJournal of Cellular Biochemistry
Volume56
Issue numberSUPPL. 20
DOIs
StatePublished - 1994

Fingerprint

Planning
Chemoprevention
Pharmaceutical Preparations
Acetylcysteine
Fenretinide
Clinical Trials
Pharmacodynamics
Glycyrrhetinic Acid
Sulindac
Finasteride
Eflornithine
Piroxicam
National Cancer Institute (U.S.)
Cholecalciferol
Ibuprofen
Biomarkers
Tamoxifen
Carotenoids
Vitamin E
Aspirin

ASJC Scopus subject areas

  • Biochemistry
  • Cell Biology

Cite this

Kelloff, G. J., Crowell, J. A., Boone, C. W., Steele, V. E., Lubet, R. A., Greenwald, P., ... Sigman, C. C. (1994). Strategy and planning for chemopreventive drug development: Clinical development plans. Journal of Cellular Biochemistry, 56(SUPPL. 20), 55-299. https://doi.org/10.1002/jcb.240560906

Strategy and planning for chemopreventive drug development : Clinical development plans. / Kelloff, G. J.; Crowell, J. A.; Boone, C. W.; Steele, V. E.; Lubet, R. A.; Greenwald, P.; Alberts, David 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.

In: Journal of Cellular Biochemistry, Vol. 56, No. SUPPL. 20, 1994, p. 55-299.

Research output: Contribution to journalArticle

Kelloff, GJ, Crowell, JA, Boone, CW, Steele, VE, Lubet, RA, Greenwald, P, Alberts, DS, Covey, JM, Doody, LA, Knapp, GG, Nayfield, S, Parkinson, DR, Prasad, VK, Prorok, PC, Sausville, EA & Sigman, CC 1994, 'Strategy and planning for chemopreventive drug development: Clinical development plans', Journal of Cellular Biochemistry, vol. 56, no. SUPPL. 20, pp. 55-299. https://doi.org/10.1002/jcb.240560906
Kelloff GJ, Crowell JA, Boone CW, Steele VE, Lubet RA, Greenwald P et al. Strategy and planning for chemopreventive drug development: Clinical development plans. Journal of Cellular Biochemistry. 1994;56(SUPPL. 20):55-299. https://doi.org/10.1002/jcb.240560906
Kelloff, G. J. ; Crowell, J. A. ; Boone, C. W. ; Steele, V. E. ; Lubet, R. A. ; Greenwald, P. ; Alberts, David 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. / Strategy and planning for chemopreventive drug development : Clinical development plans. In: Journal of Cellular Biochemistry. 1994 ; Vol. 56, No. SUPPL. 20. pp. 55-299.
@article{30c6f619e11e4be181f700d66b2ca3cd,
title = "Strategy and planning for chemopreventive drug development: Clinical development plans",
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{\circledR}, 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.",
author = "Kelloff, {G. J.} and Crowell, {J. A.} and Boone, {C. W.} and Steele, {V. E.} and Lubet, {R. A.} and P. Greenwald and Alberts, {David S} and Covey, {J. M.} and Doody, {L. A.} and Knapp, {G. G.} and S. Nayfield and Parkinson, {D. R.} and Prasad, {V. K.} and Prorok, {P. C.} and Sausville, {E. A.} and Sigman, {C. C.}",
year = "1994",
doi = "10.1002/jcb.240560906",
language = "English (US)",
volume = "56",
pages = "55--299",
journal = "Journal of Cellular Biochemistry",
issn = "0730-2312",
publisher = "Wiley-Liss Inc.",
number = "SUPPL. 20",

}

TY - JOUR

T1 - Strategy and planning for chemopreventive drug development

T2 - Clinical development plans

AU - Kelloff, G. J.

AU - Crowell, J. A.

AU - Boone, C. W.

AU - Steele, V. E.

AU - Lubet, R. A.

AU - Greenwald, P.

AU - Alberts, David S

AU - Covey, J. M.

AU - Doody, L. A.

AU - Knapp, G. G.

AU - Nayfield, S.

AU - Parkinson, D. R.

AU - Prasad, V. K.

AU - Prorok, P. C.

AU - Sausville, E. A.

AU - Sigman, C. C.

PY - 1994

Y1 - 1994

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=0028630961&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0028630961&partnerID=8YFLogxK

U2 - 10.1002/jcb.240560906

DO - 10.1002/jcb.240560906

M3 - Article

AN - SCOPUS:0028630961

VL - 56

SP - 55

EP - 299

JO - Journal of Cellular Biochemistry

JF - Journal of Cellular Biochemistry

SN - 0730-2312

IS - SUPPL. 20

ER -