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Biomedical subjects

P Greenwald

Publications and source records attributed to P Greenwald.

At least 19 recordsLinked to original sources

New directions in dietary studies in cancer: the National Cancer Institute.

Through an orderly sequence incorporating epidemiologic and laboratory research, human clinical/metabolic studies, and clinical intervention trials, the NCI develops and maintains cancer prevention and control programs that are directed toward the overall goal to reduce cancer incidence, morbidity, and mortality. Epidemiologic studies have shown correlations between consumption of numerous dietary constituents and cancer risk. Results of in vitro and animal studies have reinforced many of these epidemiologic associations and data from clinical/metabolic studies are being used to evaluate the relevance of these associations in humans. Although much remains to be learned about the influence of specific dietary constituents and dietary patterns on cancer risk, it is clear that diet can have a significant impact in cancer prevention and control. Investigations on the cellular and molecular effects of dietary constituents, as well as their metabolic and physiologic effects should provide better insight on the mechanisms of action of these dietary constituents. There also is a need to develop biomarkers of dietary intake that could be used to monitor compliance in intervention studies, as well as biomarkers as clinical trial endpoints that can be used to predict the emergence and progression of cancer. Working with other agencies and the private sector, the NCI will continue to design and implement information programs that translate the knowledge gained from these diet and cancer prevention studies to help Americans adopt dietary patterns that may reduce cancer risk. Continued emphasis will be placed on intervention programs targeted toward high-risk and underserved segments of the U.S. population in an effort to reduce the high incidence of cancers in these groups.

Animals

Strategy and planning for chemopreventive drug development: clinical development plans. Chemoprevention Branch and Agent Development Committee. National Cancer Institute.

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.

Clinical Trials as Topic