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Strategy and planning for chemopreventive drug development: clinical development plans. Chemoprevention Branch and
G J Kelloff1, J A Crowell, C W Boone
1Chemoprevention Branch, National Cancer Institute (NCI), Bethesda, MD 20892, USA.
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, beta-carotene, 2-difluoromethylornithine (DFMO), DHEA analog 8354, 18 beta-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.
Insights
The National Cancer Institute develops strategies for advancing promising cancer chemopreventive drugs. This includes detailed Clinical Development Plans for agents like aspirin and tamoxifen to guide future research.
Area of Science:
- Oncology
- Pharmacology
- Drug Development
Background:
- The National Cancer Institute's Chemoprevention Branch and Agent Development Committee focus on identifying and advancing promising cancer chemopreventive agents.
- Rigorous scientific review of testing methods and results is integral to agent evaluation and development.
Framework:
- The Clinical Development Plan (CDP) summarizes an agent's safety and efficacy data from preclinical and clinical studies.
- CDPs outline strategies for further drug development, including pharmacodynamics, biomarker monitoring, toxicity, and regulatory pathways.
Implementation:
- Sixteen CDPs are presented, covering diverse agents such as N-acetyl-l-cysteine (NAC), aspirin, calcium, beta-carotene, and vitamin E.
- These plans detail the development status and future strategy for each agent.
Implications:
- Publication of these CDPs aims to foster scientific interest and discussion on cancer chemopreventive drug development.
- Encouraging community engagement can accelerate the identification and clinical advancement of novel chemopreventive therapies.