臨床終點委員會在臨床事件判定過程中的重要作用_《中國循證醫學雜志》

作者：

王彩虹 ¹ , 趙葉琳 ¹ , 邢君 ¹ , 朱寅 ¹ ,  高潤霖 ²

1. 永銘誠道（北京）醫學科技股份有限公司（北京 100027）；2. 中國醫學科學院阜外心血管病醫院（北京 100037）;

關鍵詞：

臨床終點委員會心血管終點事件 ARC

DOI：

10.7507/1672-2531.20130217

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臨床終點委員會（CEC）在臨床試驗終點事件的判定過程中具有重要作用，尤其是在學術聯合會（ARC）定義出現之后，其對試驗質控的重要性日益突出。本文介紹CEC在臨床試驗質量控制過程中的作用及目前國內外關于CEC的應用和CEC對主要終點的影響，分析CEC在心血管領域中的應用及發展情況，探討如何合理使用CEC并使之發揮最大作用。

引用本文： 王彩虹,趙葉琳,邢君,朱寅,高潤霖. 臨床終點委員會在臨床事件判定過程中的重要作用. 中國循證醫學雜志, 2013, 13(10): 1269-1272. doi: 10.7507/1672-2531.20130217 復制

1.	Food US. Drug and Administration (2001) Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees. MD: FDA. Available from: http://www.fda .gov/RegulatoryIn-//formation/Guidances/ucm127069 htm.
2.	European Medicines Agency. Committee for Medicinal Products for Human Use(CHMP). 2005. Available from: http://wwwemeaeuropaeu/pdfs/human/ewp/587203enpdf.
3.	Food & Drug Administration. Guidance for industry diabetes mellitus—evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. Center for Drug Evaluation and Research, Silver Spring, MD, USA, 2008.
4.	FDA Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence. 2011.
5.	Dechartres A, Boutron I, Roy C, et al. Inadequate planning and reporting of adjudication committees in clinical trials: recommendation proposal. J Clin Epidemiol, 2009, 62(7): 695-702.
6.	The IMPACT-II Investigators. Randomised placebo-controlled trial of effect of eptifibatide on complications of percutaneous coronary intervention: IMPACT-II. Integrilin to Minimise Platelet Aggregation and Coronary Thrombosis-II. Lancet, 1997, 349(9063): 1422-1428.
7.	Mahaffey KW, Harrington RA, Akkerhuis M, et al. Systematic adjudication of myocardial infarction end-points in an international clinical trial. Curr Control Trials Cardiovasc Med, 2001, 2(4): 180-186.
8.	McGarvey LP, John M, Anderson JA, et al. Ascertainment of cause-specific mortality in COPD: operations of the TORCH Clinical Endpoint Committee. Thorax, 2007, 62(5): 411-415.
9.	Mahaffey KW, Roe MT, Dyke CK, et al. Misreporting of myocardial infarction end points: results of adjudication by a central clinical events committee in the PARAGON-B trial. Second Platelet IIb/IIIa Antagonist for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network Trial. Am Heart J, 2002, 143(2): 242-248.
10.	Näslund U, Grip L, Fischer-Hansen J. The impact of an end-point committee in a large multicentre, randomized, placebo-controlled clinical trial. European Heart Journal, 1999, 20(10): 771-777.
11.	Mahaffey K, Harrington R, Akkerhuis M, et al. Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study. Current Controlled Trials in Cardiovascular Medicine, 2001, 2(4): 187-194.
12.	Dhainaut JF, Laterre PF, LaRosa SP, et al. The clinical evaluation committee in a large multicenter phase 3 trial of drotrecogin alfa (activated) in patients with severe sepsis (PROWESS): role, methodology, and results. Crit Care Med, 2003, 31(9): 2291-2301.
13.	Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation, 2007, 115(17): 2344-2351.
14.	Gurvitch R, Toggweiler S, Willson AB, et al. Outcomes and complications of transcatheter aortic valve replacement using a balloon expandable valve according to the Valve Academic Research Consortium (VARC) guidelines. EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2011, 7(1): 41-48.
15.	Serruys PW, Onuma Y, Garg S, et al. 5-year clinical outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the sirolimus-eluting stent in the treatment of patients with multivessel de novo coronary artery lesions. Journal of the American College of Cardiology, 2010, 55(11): 1093-1101.
16.	Colombo A, Bramucci E, Saccà S, et al. Randomized study of the crush technique versus provisional side-branch stenting in true coronary bifurcations. Circulation, 2009, 119(1): 71-78.
17.	Spaulding C, Teiger E, Commeau P, et al. Four-year follow-up of TYPHOON (trial to assess the use of the CYPHer sirolimus-eluting coronary stent in acute myocardial infarction treated with BallOON angioplasty). JACC Interventions, 2011, 4(1): 14-23.
18.	Leon MB, Mauri L, Popma JJ, et al. A randomized comparison of the ENDEAVOR zotarolimus-eluting stent versus the TAXUS paclitaxel-eluting stent in de novo native coronary lesions: 12-month outcomes from the ENDEAVOR IV trial. Journal of the American College of Cardiology, 2010, 55(6): 543-554.
19.	Weisz G, Leon MB, Holmes DR, et al. Five-year follow-up after sirolimus-eluting stent implantation: results of the SIRIUS (Sirolimus-Eluting Stent in De-Novo Native Coronary Lesions) trial. Journal of the American College of Cardiology, 2009, 53(17): 1488-1497.
20.	Caixeta A, Leon MB, Lansky AJ, et al. 5-Year clinical outcomes after sirolimus-eluting stent implantation: insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents. Journal of the American College of Cardiology, 2009, 54(10): 894-902.
21.	Stone GW, Midei M, Newman W, et al. Randomized comparison of everolimus-eluting and paclitaxel-eluting stents two-year clinical follow-up from the clinical evaluation of the Xience V Everolimus Eluting Coronary Stent System in the treatment of patients with de novo native coronary artery lesions (SPIRIT) III Trial. Circulation, 2009, 119(5): 680-686.
22.	Urban P, Abizaid A, Banning A, et al. Stent Thrombosis and Bleeding Complications After Implantation of Sirolimus-Eluting Coronary Stents in an Unselected Worldwide Population: A Report From the e-SELECT (Multi-Center Post-Market Surveillance) Registry. Journal of the American College of Cardiology, 2011, 57(13): 1445-1454.
23.	Gao R, Xu B, Chen J, et al. Two-year clinical outcomes following elective drug-eluting versus bare-metal stent implantation: results from a large single-center database. Chinese Medical Journal (English Edition), 2009, 122(19): 2261.
24.	Gao R, Abizaid A, Banning A, et al. one-year outcome of small-vessel disease treated with sirolimus-eluting stents: a subgroup analysis of the e-select registry. Journal of the American College of Cardiology, 2011, 57(14 Suppl S): E1840.
25.	Ge J, Zhang F, Qian J, et al. Six-month clinical outcomes of Firebird 2TM sirolimus-eluting stent implantation in real-world patients with coronary artery diseases. Chinese Medical Journal, 2011, 124(6): 831-835.
26.	Han Y, Jing Q, Xu B, et al. Safety and Efficacy of Biodegradable Polymer-Coated Sirolimus-Eluting Stents in. JACC: Cardiovascular Interventions, 2009, 2(4): 303-309.
27.	Han Y, Jing Q, Li Y, et al. Sustained clinical safety and efficacy of a biodegradable-polymer coated sirolimus-eluting stent in "real-world" practice: three-year outcomes of the CREATE (Multi-Center Registry of EXCEL Biodegradable Polymer Drug Eluting Stents) study. Catheter Cardiovasc Interv, 2012, 79(2): 211-216.
28.	Heagerty A, Deverly A, Palmer C, et al. The role of the critical event committee in a major cardiovascular outcome study. Blood Pressure, 2002, 11(6): 339-344.
29.	Petersen JL, Haque G, Hellkamp AS, et al. Comparing classifications of death in the Mode Selection Trial: agreement and disagreement among site investigators and a clinical events committee. Contemp Clin Trials, 2006, 27(3): 260-268.
30.	Pogue J, Walter SD, Yusuf S. Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs. Clin Trials, 2009, 6(3): 239-251.
31.	Ninomiya T, Donnan G, Anderson N, et al. Effects of the end point adjudication process on the results of the perindopril protection against recurrent stroke study (PROGRESS). Stroke, 2009, 40(6): 2111-2115.
32.	Barringhaus KG, Zelevinsky K, Lovett A, et al. Impact of independent data adjudication on hospital-specific estimates of risk-adjusted mortality following percutaneous coronary interventions in Massachusetts. Circulation: Cardiovascular Quality and Outcomes, 2011, 4(1): 92-98.
33.	Yusuf S, Mehta SR, Chrolavicius S, et al. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med, 2006, 354(14): 1464-1476.

1. Food US. Drug and Administration (2001) Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees. MD: FDA. Available from: http://www.fda .gov/RegulatoryIn-//formation/Guidances/ucm127069 htm.
2. European Medicines Agency. Committee for Medicinal Products for Human Use(CHMP). 2005. Available from: http://wwwemeaeuropaeu/pdfs/human/ewp/587203enpdf.
3. Food & Drug Administration. Guidance for industry diabetes mellitus—evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. Center for Drug Evaluation and Research, Silver Spring, MD, USA, 2008.
4. FDA Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence. 2011.
5. Dechartres A, Boutron I, Roy C, et al. Inadequate planning and reporting of adjudication committees in clinical trials: recommendation proposal. J Clin Epidemiol, 2009, 62(7): 695-702.
6. The IMPACT-II Investigators. Randomised placebo-controlled trial of effect of eptifibatide on complications of percutaneous coronary intervention: IMPACT-II. Integrilin to Minimise Platelet Aggregation and Coronary Thrombosis-II. Lancet, 1997, 349(9063): 1422-1428.
7. Mahaffey KW, Harrington RA, Akkerhuis M, et al. Systematic adjudication of myocardial infarction end-points in an international clinical trial. Curr Control Trials Cardiovasc Med, 2001, 2(4): 180-186.
8. McGarvey LP, John M, Anderson JA, et al. Ascertainment of cause-specific mortality in COPD: operations of the TORCH Clinical Endpoint Committee. Thorax, 2007, 62(5): 411-415.
9. Mahaffey KW, Roe MT, Dyke CK, et al. Misreporting of myocardial infarction end points: results of adjudication by a central clinical events committee in the PARAGON-B trial. Second Platelet IIb/IIIa Antagonist for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network Trial. Am Heart J, 2002, 143(2): 242-248.
10. Näslund U, Grip L, Fischer-Hansen J. The impact of an end-point committee in a large multicentre, randomized, placebo-controlled clinical trial. European Heart Journal, 1999, 20(10): 771-777.
11. Mahaffey K, Harrington R, Akkerhuis M, et al. Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study. Current Controlled Trials in Cardiovascular Medicine, 2001, 2(4): 187-194.
12. Dhainaut JF, Laterre PF, LaRosa SP, et al. The clinical evaluation committee in a large multicenter phase 3 trial of drotrecogin alfa (activated) in patients with severe sepsis (PROWESS): role, methodology, and results. Crit Care Med, 2003, 31(9): 2291-2301.
13. Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation, 2007, 115(17): 2344-2351.
14. Gurvitch R, Toggweiler S, Willson AB, et al. Outcomes and complications of transcatheter aortic valve replacement using a balloon expandable valve according to the Valve Academic Research Consortium (VARC) guidelines. EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2011, 7(1): 41-48.
15. Serruys PW, Onuma Y, Garg S, et al. 5-year clinical outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the sirolimus-eluting stent in the treatment of patients with multivessel de novo coronary artery lesions. Journal of the American College of Cardiology, 2010, 55(11): 1093-1101.
16. Colombo A, Bramucci E, Saccà S, et al. Randomized study of the crush technique versus provisional side-branch stenting in true coronary bifurcations. Circulation, 2009, 119(1): 71-78.
17. Spaulding C, Teiger E, Commeau P, et al. Four-year follow-up of TYPHOON (trial to assess the use of the CYPHer sirolimus-eluting coronary stent in acute myocardial infarction treated with BallOON angioplasty). JACC Interventions, 2011, 4(1): 14-23.
18. Leon MB, Mauri L, Popma JJ, et al. A randomized comparison of the ENDEAVOR zotarolimus-eluting stent versus the TAXUS paclitaxel-eluting stent in de novo native coronary lesions: 12-month outcomes from the ENDEAVOR IV trial. Journal of the American College of Cardiology, 2010, 55(6): 543-554.
19. Weisz G, Leon MB, Holmes DR, et al. Five-year follow-up after sirolimus-eluting stent implantation: results of the SIRIUS (Sirolimus-Eluting Stent in De-Novo Native Coronary Lesions) trial. Journal of the American College of Cardiology, 2009, 53(17): 1488-1497.
20. Caixeta A, Leon MB, Lansky AJ, et al. 5-Year clinical outcomes after sirolimus-eluting stent implantation: insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents. Journal of the American College of Cardiology, 2009, 54(10): 894-902.
21. Stone GW, Midei M, Newman W, et al. Randomized comparison of everolimus-eluting and paclitaxel-eluting stents two-year clinical follow-up from the clinical evaluation of the Xience V Everolimus Eluting Coronary Stent System in the treatment of patients with de novo native coronary artery lesions (SPIRIT) III Trial. Circulation, 2009, 119(5): 680-686.
22. Urban P, Abizaid A, Banning A, et al. Stent Thrombosis and Bleeding Complications After Implantation of Sirolimus-Eluting Coronary Stents in an Unselected Worldwide Population: A Report From the e-SELECT (Multi-Center Post-Market Surveillance) Registry. Journal of the American College of Cardiology, 2011, 57(13): 1445-1454.
23. Gao R, Xu B, Chen J, et al. Two-year clinical outcomes following elective drug-eluting versus bare-metal stent implantation: results from a large single-center database. Chinese Medical Journal (English Edition), 2009, 122(19): 2261.
24. Gao R, Abizaid A, Banning A, et al. one-year outcome of small-vessel disease treated with sirolimus-eluting stents: a subgroup analysis of the e-select registry. Journal of the American College of Cardiology, 2011, 57(14 Suppl S): E1840.
25. Ge J, Zhang F, Qian J, et al. Six-month clinical outcomes of Firebird 2TM sirolimus-eluting stent implantation in real-world patients with coronary artery diseases. Chinese Medical Journal, 2011, 124(6): 831-835.
26. Han Y, Jing Q, Xu B, et al. Safety and Efficacy of Biodegradable Polymer-Coated Sirolimus-Eluting Stents in. JACC: Cardiovascular Interventions, 2009, 2(4): 303-309.
27. Han Y, Jing Q, Li Y, et al. Sustained clinical safety and efficacy of a biodegradable-polymer coated sirolimus-eluting stent in "real-world" practice: three-year outcomes of the CREATE (Multi-Center Registry of EXCEL Biodegradable Polymer Drug Eluting Stents) study. Catheter Cardiovasc Interv, 2012, 79(2): 211-216.
28. Heagerty A, Deverly A, Palmer C, et al. The role of the critical event committee in a major cardiovascular outcome study. Blood Pressure, 2002, 11(6): 339-344.
29. Petersen JL, Haque G, Hellkamp AS, et al. Comparing classifications of death in the Mode Selection Trial: agreement and disagreement among site investigators and a clinical events committee. Contemp Clin Trials, 2006, 27(3): 260-268.
30. Pogue J, Walter SD, Yusuf S. Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs. Clin Trials, 2009, 6(3): 239-251.
31. Ninomiya T, Donnan G, Anderson N, et al. Effects of the end point adjudication process on the results of the perindopril protection against recurrent stroke study (PROGRESS). Stroke, 2009, 40(6): 2111-2115.
32. Barringhaus KG, Zelevinsky K, Lovett A, et al. Impact of independent data adjudication on hospital-specific estimates of risk-adjusted mortality following percutaneous coronary interventions in Massachusetts. Circulation: Cardiovascular Quality and Outcomes, 2011, 4(1): 92-98.
33. Yusuf S, Mehta SR, Chrolavicius S, et al. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med, 2006, 354(14): 1464-1476.

《中國循證醫學雜志》

臨床終點委員會在臨床事件判定過程中的重要作用

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《中國循證醫學雜志》

臨床終點委員會在臨床事件判定過程中的重要作用

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