Bigger, Jr., J. T. 1986. Long-term continuous electrocardiographic recordings and electrophysiologic testing to select patients with ventricular arrhythmias for drug trials and to determine antiarrhythmic drug efficacy. American Journal of Cardiology 58(5):58C–65C.

Biomarkers Definitions Working Group. 2001. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clinical Pharmacology and Therapeutics 69(3):89–95.

Califf, R. M. 2006. Clinical trials bureaucracy: Unintended consequences of well-intentioned policy. Clinical Trials 3(6):496–502.

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. New England Journal of Medicine 321(6):406–412.

Castelli, W. P. 1988. Cholesterol and lipids in the risk of coronary artery disease—The Framingham Heart Study. Canadian Journal of Cardiology 4(Suppl A):5A–10A.

CFSAN (Center for Food Safety and Applied Nutrition). 2009. Guidance for industry: Evidence-based review system for the scientific evaluation of health claims. http://www.cfsan.fda. gov/~dms/hclmgui6.html (accessed February 25, 2009).

Cook, N. R., J. E. Buring, and P. M. Ridker. 2006. The effect of including C-reactive protein in cardiovascular risk prediction models for women. Annals of Internal Medicine 145(1):21–29.

de Lorgeril, M., P. Salen, J. L. Martin, I. Monjaud, J. Delaye, and N. Mamelle. 1999. Mediterranean diet, traditional risk factors, and the rate of cardiovascular complications after myocardial infarction: Final report of the Lyon Diet Heart Study. Circulation 99(6):779–785.

Dieterle, F., F. Sistare, F. Goodsaid, M. Papaluca, J. S. Ozer, C. P. Webb, W. Baer, A. Senagore, M. J. Schipper, J. Vonderscher, S. Sultana, D. L. Gerhold, J. A. Phillips, G. Maurer, K. Carl, D. Laurie, E. Harpur, M. Sonee, D. Ennulat, D. Holder, D. Andrews-Cleavenger, Y. Z. Gu, K. L. Thompson, P. L. Goering, J. M. Vidal, E. Abadie, R. Maciulaitis, D. Jacobson-Kram, A. F. Defelice, E. A. Hausner, M. Blank, A. Thompson, P. Harlow, D. Throckmorton, S. Xiao, N. Xu, W. Taylor, S. Vamvakas, B. Flamion, B. S. Lima, P. Kasper, M. Pasanen, K. Prasad, S. Troth, D. Bounous, D. Robinson-Gravatt, G. Betton, M. A. Davis, J. Akunda, J. E. McDuffie, L. Suter, L. Obert, M. Guffroy, M. Pinches, S. Jayadev, E. A. Blomme, S. A. Beushausen, V. G. Barlow, N. Collins, J. Waring, D. Honor, S. Snook, J. Lee, P. Rossi, E. Walker, and W. Mattes. 2010. Renal biomarker qualification submission: A dialog between the FDA-EMEA and Predictive Safety Testing Consortium. Nature Biotechnology 28(5):455–462.

Dluhy, R. G., and G. T. McMahon. 2008. Intensive glycemic control in the ACCORD and ADVANCE trials. New England Journal of Medicine 358(24):2630–2633.

Echt, D. S., P. R. Liebson, L. B. Mitchell, R. W. Peters, D. Obias-Manno, A. H. Barker, D. Arensberg, A. Baker, L. Friedman, H. L. Greene, M. L. Huther, D. W. Richardson, and CAST Investigators. 1991. Mortality and morbidity in patients receiving encainide, flecainide, or placebo: The Cardiac Arrhythmia Suppression Trial. New England Journal of Medicine 324(12):781–788.

FDA (Food and Drug Administration). 2009. Summary of qualified health claims subject to enforcement discretion. (accessed October 12, 2010).

Fleming, T. R. 2005. Surrogate endpoints and FDA’s accelerated approval process. Health Affairs (Millwood) 24(1):67–78.

Fleming, T. R., and D. L. DeMets. 1996. Surrogate end points in clinical trials: Are we being misled? Annals of Internal Medicine 125(7):605–613.

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