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Journal of Clinical Epidemiology
Volume 62, Issue 12
, Pages 1306-1315
, December 2009
Changes in surrogate outcomes can be translated into clinical outcomes using a Monte Carlo model
References
- . Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies. Annu Rev Pharmacol Toxicol. 2001;41:347–366
- Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop. Control Clin Trials. 2001;22:485–502
- . A regulatory authority's opinion about surrogate endpoints. In: Nimmo WS, Tucker GT editor. Clinical Measurement in Drug Evaluation. New York: J Wiley; 1995;p. 3–22
- . Surrogate endpoints: a basis for a rational approach. Eur J Clin Pharmacol. 1992;43(3):235–244
- Statistical issues for HIV surrogate endpoints: point/counterpoint. An NIAID workshop. Stat Med. 1998;17(21):2435–2462
- MRI as a biomarker of disease progression in a therapeutic trial of milameline for AD. Neurology. 2003;60:253–260
- . Using serial registered brain magnetic resonance imaging to measure disease progression in Alzheimer disease: power calculations and estimates of sample size to detect treatment effects. Arch Neurol. 2000;57:339–344
- . The contribution of clinical pharmacology surrogates and models to drug development—a critical appraisal. Br J Clin Pharmacol. 1997;44(3):219–225
- . Surrogate end points in heart failure. J Am Coll Cardiol. 2002;39(9):1414–1421
- . Surrogate endpoints in clinical trials: cancer. Stat Med. 1989;8:405–413
- . Randomized clinical trials on surrogate end points: are they useful for evaluating cardiovascular and renal disease protection in hypertension? The case for yes. J Am Soc Nephrol. 2006;17(4 Suppl. 2):S141–S144
- . Debate: the slippery slote of surrogate outcomes. Curr Control Trials Cardiovasc Med. 2000;1:76–78
- . Bayesian estimation of the proportion of treatment effect captured by a surrogate marker. Stat Med. 2002;21(6):811–834
- Food and Drug Administration Moderization Act of 1997. Sec. 112. Expediting study and approval of fast track drugs. 1997.
- . Estimating the proportion of treatment effect explained by a surrogate marker. Stat Med. 1997;16(13):1515–1527
- . Statistical validation of intermediate endpoints for chronic diseases. Stat Med. 1992;11(2):167–178
- . Statistical challenges in the evaluation of surrogate endpoints in randomized trials. Control Clin Trials. 2002;23:607–625
- . Surrogate end points in clinical trials: are we being misled?. Ann Intern Med. 1996;125(7):605–613
- . Quantifying the indirect treatment effect via surrogate markers. Stat Med. 2006;25:223–231
- . Design considerations for efficient prostate cancer chemoprevention trials. Urology. 2001;57(4 Suppl. 1):205–212
- . Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther. 2001;69(3):89–95
- . Surrogate end points in clinical research: hazardous to your health. Obstet Gynecol. 2005;105(5 Pt 1):1114–1118
- Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1991;324(12):781–788
- Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group. JAMA. 1998;280(7):605–613
- Effect of fluoride treatment on the fracture rate in postmenopausal women with osteoporosis. N Engl J Med. 1990;322(12):802–809
- . Meta-analysis for the evaluation of potential surrogate markers. Stat Med. 1997;16(17):1965–1982
- . A simple meta-analytic approach for using a binary surrogate endpoint to predict the effect of intervention on true endpoint. Biostatistics. 2006;7:58–70
- . The association between anticoagulation intensity and outcomes for oral anticoagulant users: a systematic review and meta-analysis. Can Med Assoc J. 2008;179:235–244
- . Generating univariate random numbers in SAS. SAS for Monte Carlo studies: a guide for quantitative researchers. Cary, NC: SAS Institute; 2001;25–59
- . Confidence limits for the ratio of two rates based on likelihood scores: non-iterative method. Stat Med. 2003;22(12):2071–2083
- . Assessing the minimal important difference in symptoms: a comparison of two techniques. J Clin Epidemiol. 1996;49(11):1215–1219
- . Effect of study setting on anticoagulation control: a systematic review and metaregression. Chest. 2006;129(5):1155–1166
- . Self-managed anticoagulation: results from a two-year prospective randomized trial with heart valve patients. Ann Thorac Surg. 2001;72(5):1523–1527
- . Evaluation of a decision support system for initiation and control of oral anticoagulation in a randomised trial. Br Med J. 1997;314(7089):1252–1256
- . Improving the quality of anticoagulation of patients with atrial fibrillation in managed care organizations: results of the managing anticoagulation services trial. Am J Med. 2002;113:42–51
- Efficacy of computer-aided dosing of warfarin among patients in a rehabilitation hospital. Am J Phys Med Rehabil. 2005;84(6):423–427
- . Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med. 1989;8:431–440
- . Comparison of three methods to assess therapeutic quality control of treatment with vitamin K antagonists. Thromb Haemost. 1999;82(4):1260–1263
- Management of Chinese patients on warfarin therapy in two models of anticoagulation service—a prospective randomized trial. Br J Clin Pharmacol. 2006;62:601–609
- Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial. Ann Intern Med. 2005;142:1–10
- Self management of oral anticoagulation: randomised trial. Br Med J. 2005;331(7524):1057
- Oral anticoagulation management in primary care with the use of computerized decision support and near-patient testing: a randomized, controlled trial. Arch Intern Med. 2000;160(15):2343–2348
- Comparing the quality of oral anticoagulant management by anticoagulation clinics and by family physicians: a randomized controlled trial. Can Med Assoc J. 2003;169(4):293–298
- . A perfect correlate does not a surrogate make. BMC Med Res Methodol. 2003;3:16
- A randomized controlled trial of shared care versus routine care for patients receiving oral anticoagulant therapy. J Intern Med. 2002;252(4):322–331
- A randomised control trial of patient self-management of oral anticoagulation compared with patient self-testing. Br J Haematol. 2006;132:598–603
- . A randomised controlled trial of patient self management of oral anticoagulation treatment compared with primary care management. J Clin Pathol. 2002;55(11):845–849
- Reliability of point-of-care prothrombin time testing in a community clinic: a randomized crossover comparison with hospital laboratory testing. Br J Haematol. 2002;119(2):370–375
- The quality of routine oral anticoagulant therapy in a large geographical area. A survey of 310,300 inhabitants. Dan Med Bull. 2002;49(3):252–255
- Compliance and stability of INR of two oral anticoagulants with different half-lives: a randomised trial. Thromb Haemost. 2003;89(3):458–467
- . Oral anticoagulation and risk of death: a medical record linkage study. Br Med J. 2002;325(7372):1073–1075
- Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med. 2003;349(11):1019–1026
- . Burden of potentially avoidable anticoagulant-associated hemorrhagic and thromboembolic events in the elderly. Chest. 2007;131:1508–1515
- . Medium intensity oral anticoagulants versus aspirin after cerebral ischaemia of arterial origin (ESPRIT): a randomised controlled trial. Lancet Neurol. 2007;6(2):115–124
- Comparison of low-intensity warfarin therapy with conventional-intensity warfarin therapy for long-term prevention of recurrent venous thromboembolism. N Engl J Med. 2003;349(7):631–639
- A comparison of the safety and efficacy of oral anticoagulation for the treatment of venous thromboembolic disease in patients with or without malignancy. Thromb Haemost. 2000;84(5):805–810
- . ISCOAT Study Group. Oral anticoagulant therapy in patients with nonrheumatic atrial fibrillation and risk of bleeding. A Multicenter Inception Cohort Study. Thromb Haemost. 2001;85(3):418–422
- Quality of anticoagulation control and costs of monitoring warfarin therapy among patients with atrial fibrillation in clinic settings: a multi-site managed-care study. Ann Pharmacother. 2005;39(3):446–451
- . Is INR between 2.0 and 3.0 the optimal level for Chinese patients on warfarin therapy for moderate-intensity anticoagulation?. Br J Clin Pharmacol. 2005;59:582–587
- . Low-dose warfarin in patients with Carbomedics heart valve prostheses. Asian Cardiovasc Thorac Ann. 2000;8:11–14
- Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005;352:1305–1316
- . Comparison of an anticoagulation clinic with usual medical care: anticoagulation control, patient outcomes, and health care costs. Arch Intern Med. 1998;158(15):1641–1647
- Effectiveness of fixed minidose warfarin in the prevention of thromboembolism and vascular death in nonrheumatic atrial fibrillation. Am J Cardiol. 1998;82:433–437
- Quality of anticoagulation management among patients with atrial fibrillation: results of a review of medical records from 2 communities. Arch Intern Med. 2000;160(7):967–973
- Performance of prothrombin-proconvertin time as a monitoring test of oral anticoagulation therapy. Am J Clin Pathol. 1997;107:672–680
PII: S0895-4356(09)00052-3
doi: 10.1016/j.jclinepi.2009.01.015
© 2009 Elsevier Inc. All rights reserved.
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Journal of Clinical Epidemiology
Volume 62, Issue 12
, Pages 1306-1315
, December 2009
