April 15-16, 1999 SELECTED REFERENCES Note: Many of the references below are accessible through links to the National Library of Medicine's PubMed System. Click on the underlined link below to access this system. Atkinson, A.J., Jr., & Collins, J.M. "Kinetic Analysis of Biomarkers."
Presentation for the course "Principles in Clinical Pharmacology." http://www.cc.nih.gov/ccc/principles/pdf/kineticanalysis.pdf Blue, J. W., & Colburn, W. A. (1996). Efficacy measures: surrogates or clinical outcomes? [editorial]. J Clin Pharmacol, 36(9), 767-770. Boissel, J. P., Collet, J. P., Moleur, P., & Haugh, M. (1992). Surrogate endpoints: a basis for a rational approach. Eur J Clin Pharmacol, 43(3), 235-244. Cannon, C. P. (1997). Clinical perspectives on the use of composite endpoints. Control Clin Trials, 18(6), 517-529; discussion 546-549. Cardiac Arrhythmia Suppression Trial (CAST) Investigators. (1989). Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators. N Engl J Med, 321(6), 406-412; comments 386-388, 321(25), 1754-1756. Carr, G. (1998). A survey of the pharmaceutical industry. Economist, 346, 1-18. Chernoff, D. N., Miner, R. C., Hoo, B. S., Shen, L. P., Kelso, R. J., Jekic-McMullen, D., Lalezari, J. P., Chou, S., Drew, W. L., & Kolberg, J. A. (1997). Quantification of cytomegalovirus DNA in peripheral blood leukocytes by a branched-DNA signal amplification assay. J Clin Microbiol, 35(11), 2740-2744. Colburn, W. A. (1995). Surrogate markers and clinical pharmacology. J Clin Pharmacol, 35(5), 441-442; comment 464-470. Colburn, W. A. (1997). Selecting and validating biologic markers for drug development. J Clin Pharmacol, 37(5), 355-362. Daniels, M. J., & Hughes, M. D. (1997). Meta-analysis for the evaluation of potential surrogate markers. Stat Med, 16(17), 1965-1982. De Gruttola, V., Fleming, T., Lin, D. Y., & Coombs, R. (1997). Perspective: validating surrogate markers--are we being naive? J Infect Dis, 175(2), 237-246. Deyton, L. (1996). Importance of surrogate markers in evaluation of antiviral therapy for HIV infection. JAMA, 276(2), 159-160. Ellenberg, S., & Hamilton, J. M. (1989). Surrogate endpoints in clinical trials: cancer. Stat Med, 8(4), 405-413. Ellenberg, S. S. (1991). Surrogate end points in clinical trials [editorial; comment]. BMJ, 302(6768), 63-64. Ellenberg, S. S. (1993). Surrogate endpoints [editorial]. Br J Cancer, 68(3), 457-459. Figg, W. D., Sartor, O., Cooper, M. R., Thibault, A., Bergan, R. C., Dawson, N., Reed, E., & Myers, C. E. (1995). Prostate specific antigen decline following the discontinuation of flutamide in patients with stage D2 prostate cancer. Am J Med, 98(4), 412-414; comment 100(2), 243-244. Figg, W. D., Ammerman, K., Patronas, N., Steinberg, S. M., Walls, R. G., Dawson, N., Reed, E., & Sartor, O. (1996). Lack of correlation between prostate-specific antigen and the presence of measurable soft tissue metastases in hormone-refractory prostate cancer. Cancer Invest, 14(6), 513-517. Filippi, M., Horsfield, M. A., Ader, H. J., Barkhof, F., Bruzzi, P., Evans, A., Frank, J. A., Grossman, R. I., McFarland, H. F., Molyneux, P., Paty, D. W., Simon, J., Tofts, P. S., Wolinsky, J. S., & Miller, D. H. (1998). Guidelines for using quantitative measures of brain magnetic resonance imaging abnormalities in monitoring the treatment of multiple sclerosis. Ann Neurol, 43, 499-506. Fleming, T. R., & DeMets, D. L. (1996). Surrogate end points in clinical trials: are we being misled? Ann Intern Med, 125(7), 605-613; comment 126(8), 667. Fowler, J. S., Volkow, N. D., Logan, J., Schlyer, D. J., MacGregor, R. R., Wang, G. J., Wolf, A. P., Pappas, N., Alexoff, D., Shea, C., et al. (1993). Monoamine oxidase B (MAO B) inhibitor therapy in Parkinson's disease: the degree and reversibility of human brain MAO B inhibition by Ro 19 6327. Neurology, 43(10), 1984-1992. Fowler, J. S., Volkow, N. D., Logan, J., Wang, G. J., MacGregor, R. R., Schyler, D., Wolf, A. P., Pappas, N., Alexoff, D., Shea, C., et al. (1994). Slow recovery of human brain MAO B after L-deprenyl (Selegeline) withdrawal. Synapse, 18(2), 86-93. Freedman, L. S., Graubard, B. I., & Schatzkin, A. (1992). Statistical validation of intermediate endpoints for chronic diseases. Stat Med, 11(2), 167-178. Hughes, M. D., DeGruttola, V., & Welles, S. L. (1995). Evaluating surrogate markers. J Acquir Immune Defic Syndr Hum Retrovirol, 10 Suppl 2:S1-8, S1-8. Kelly, W. K., Scher, H. I., Mazumdar, M., Vlamis, V., Schwartz, M., & Fossa, S. D. (1993). Prostate-specific antigen as a measure of disease outcome in metastatic hormone-refractory prostate cancer. J Clin Oncol, 11(4), 607-615; comment 596-597. Lagakos, S. W., & Hoth, D. F. (1992). Surrogate markers in AIDS: where are we? Where are we going? [editorial]. Ann Intern Med, 116(7), 599-601; comment 117(7), 619. Lee, J. W., Hulse, J. D., & Colburn, W. A. (1995). Surrogate biochemical markers: precise measurement for strategic drug and biologics development. J Clin Pharmacol, 35(5), 464-470. Lin, D. Y., Fleming, T. R., & De Gruttola, V. (1997). Estimating the proportion of treatment effect explained by a surrogate marker. Stat Med, 16(13), 1515-1527. Lotterer, E., Hogel, J., Gaus, W., Fleig, W. E., & Bircher, J. (1997). Quantitative liver function tests as surrogate markers for end-points in controlled clinical trials: a retrospective feasibility study. Hepatology, 26(6), 1426-1433; comment 1678-1679. MacGregor, J. T., Farr, S., Tucker, J. D., Heddle, J. A., Tice, R. R., & Turteltaub, K. W. (1995). New molecular endpoints and methods for routine toxicity testing. Fundam Appl Toxicol, 26(2), 156-173. Machado, S. G., Gail, M. H., & Ellenberg, S. S. (1990). On the use of laboratory markers as surrogates for clinical endpoints in the evaluation of treatment for HIV infection. J Acquir Immun Defic Syndr, 3(11), 1065-1073. Mildvan, D., Landay, A., De Gruttola, V., Machado, S. G., & Kagan, J. (1997). An approach to the validation of markers for use in AIDS clinical trials. Clin Infect Dis, 24(5), 764-774. Niblack, J. F. (1997). Why are drug development programs growing in size and cost? A view from industry. Food Drug Law J, 52(2), 151-154. O'Neill, R. T. (1997). Secondary endpoints cannot be validly analyzed if the primary endpoint does not demonstrate clear statistical significance. Control Clin Trials, 18(6), 550-556; discussion 561-567. Peck, C. C. (1997). Drug development: improving the process. Food Drug Law J, 59(2), 163-168. Peto, T. (1996). Surrogate markers in HIV disease. J Antimicrob Chemother, 37 Suppl B:161-170. Pozniak, A. (1998). Surrogacy in HIV-1 clinical trials. Lancet, 351(9102), 536-537; comment 543-549. Prentice, R. L. (1989). Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med, 8(4), 431-440. Rolan, P. (1997). The contribution of clinical pharmacology surrogates and models to drug development--a critical appraisal. Br J Clin Pharmacol, 44(3), 219-225. Rossouw, J. E., Lewis, B., & Rifkind, B. M. (1990). The value of lowering cholesterol after myocardial infarction. N Engl J Med, 323(16), 1112-1119; comment 324(13), 922-923. Santella, R. M. (1997). DNA damage as an intermediate biomarker in intervention studies. Proc Soc Exp Biol Med, 216(2), 166-171. Schatzkin, A., Freedman, L. S., Schiffman, M. H., & Dawsey, S. M. (1990). Validation of intermediate end points in cancer research. J Natl Cancer Inst, 82(22), 1746-1752. Siegfried, J. M. (1998). Biology and chemoprevention of lung cancer. Chest, 113(1 Suppl), 40S-45S. Sridhara, R., Eisenberger, M. A., Sinibaldi, V. J., Reyno, L. M., & Egorin, M. J. (1995). Evaluation of prostate-specific antigen as a surrogate marker for response of hormone-refractory prostate cancer to suramin therapy. J Clin Oncol, 13(12), 2944-2953. Temple, R. J. (1995). A regulatory authority's opinion about surrogate endpoints. In W. S. Nimmo & G. T. Tucker (Eds.), Clinical Measurement in Drug Evaluation. (pp. 3-22). John Wiley & Sons. U.S. Government (1997). Code of Federal Regulations, 21 Part 314, Subpart H. U.S. Government (1997). Code of Federal Regulations, 21 Part 601, Subpart E. U.S. Government (1998). Federal Food, Drug, and Cosmetic Act, 21 USC 356 (Fast Track Products). Wittes, J., Lakatos, E., & Probstfield, J. (1989). Surrogate endpoints in clinical trials: cardiovascular diseases. Stat Med, 8(4), 415-425. Woodcock, J. (1997). An FDA perspective on the drug development process. Food Drug Law J, 52(2), 145-161. Yamada, T., Matsumori, A., Tamaki, S., & Sasayama, S. (1998). Myosin light chain I grade: a simple marker for the severity and prognosis of patients with acute myocardial infarction. Am Heart J, 135(2 Pt 1), 329-334.
Overview Agenda
Selected References |
