VOLUNTARY PROVISION OF INFORMATION ON BIOMARKERS AND INTERMEDIATEENDPOINTS IN PREVENTION TRIALS NIH GUIDE, Volume 23, Number 12, March 25, 1994 P.T. Keywords: National Cancer Institute The National Cancer Institute (NCI) announces the establishment of a biomarker registry comprised of information that may be useful to investigators when biomarkers are being considered as intermediate endpoints or as outcome measures in prevention trials. In an effort to collect information on biomarkers, the NCI seeks cooperation from the extramural scientific community on a voluntary basis. Information may be submitted by anyone currently engaged in biomarker research. The following characteristics of biomarkers are of interest: 1. Biological Characteristics: The description should include, but is not limited to, the spontaneous biological rate of progression and/or regression, site-specificity, histology, chromosomal aberrations, epigenetic changes, mutations, histologic correlation, and the phase, i.e., whether the marker in question occurs at an early, intermediate, or late stage of the carcinogenesis process. 2. Outcome Association: Provide information on population, subjects, sites, intermediate endpoints, and the rate of regression of intermediate endpoints in a given time frame in response to the intervention (e.g., 50 percent regression in two months). In the case of chemoprevention trials, also provide the name of the chemopreventive agent, dose (including toxicity data), preclinical efficacy, preclinical safety, clinical safety, and the clinical efficacy, if known. 3. Epidemiological Characteristics: Provide information on (1) types of marker: (a) biomarkers of susceptibility, (b) biomarkers of exposure, (c) biomarkers of biological effects, (d) biomarkers of disease cancer; (2) source of variability: sampling variability, inter- and intra-individual variability, inter- and intra- observational variability, and time-dependent variability; (3) study design: case-control, prospective cohort, or randomized trial. Provide the material for the choice of the endpoint and sample size in your study. INQUIRIES For further information, contact Barnett S. Kramer or Sudhir Srivastava Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 305 Bethesda, MD 20892 Telephone: (301) 496-8544 FAX: (301) 496-8667 .
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