Комбинированные конечные точки в клинических исследованиях: обзор публикаций (ОКОНЧАНИЕ)
Ср, 19 Янв 2011
2068

В НАЧАЛО СТАТЬИ: http://www.clinvest.ru/part.php?pid=13

Источник: От редакции. Комбинированные конечные точки в клинических исследованиях: обзор публикаций // Качественная клиническая практика, №1, 2010 г., стр. 39-53


Литература 

  1. Neaton JD, Gray G, Zuckerman BD, et al. Key issues in end point selection for heart failure trials: composite end points. J Cardiac Failure 2005; 11: 567-75
  2. International Conference on Harmonisation. ICH harmonized tripartite guideline E9: statistical principals for clinical trials [online]. Available from URL: http:// www.ich.org/LOB/media/MEDIA485.pdf [Accessed 2007 Jan 23]
  3. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiat 1960; 23: 56-62
  4. American College of Rheumatology. Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 update. Arthritis Rheum 2002; 46: 328-46
  5. Lubsen J, Kirwan B-A. Combined endpoints: can we use them? Stat Med 2002; 21: 2959-70
  6. Rappaport M. The disability rating and coma/near-coma scales in evaluating severe head injury. Neuropsychol Rehabil 2005; 15: 442-53
  7. Fredriksson T, Pettersson U. Severe psoriasis: oral therapy with a new retinoid. Dermatologica 1978; 157: 238-44
  8. Chi GYH. Some issues with composite endpoints in clinical trials. Fundam Clin Pharmacol 2005; 19: 609-19
  9. Dahlof B, Devereux RB, Kjeldsen SE, et al. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet 2002; 359: 995-1003
  10. Cohn JN, Tognoni G, for the Valsartan Heart Failure Investigators. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med 2001; 345: 1667-75
  11. Schwartz GG, Olsson AG, Ezekowitz MD, et al. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial. JAMA 2001; 285: 1711-8
  12. Gerstein HC, Yusuf S, Pogue J, et al. for the DREAM (Diabetes Reduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial. Lancet 2006; 368: 1096-105
  13. Dormandy JA, Charbonnel B, Eckland DA, et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial in macro Vascular Events): a randomised controlled trial. Lancet 2005; 366: 1279-89
  14. Lewis EJ, Hunsicker LG, Clarke WR, et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med 2001; 345: 851-60
  15. Vitko S, Margreiter R, Weimar W, et al. Everolimus (Certican) 12-month safety and efficacy versus mycophenolate mofetil in de novo renal transplant recipients. Transplantation 2004; 78: 1532-40
  16. Silverstein FE, Graham DY, Senior JR, et al. Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid arthritis receiving nonsteroidal anti-inflammatory drugs: a randomized, double-blind, placebo-controlled trial. Ann Intern Med 1995; 123: 241-9
  17. Theriault RL, Lipton A, Hortobagyi GN, et al. Pamidronate reduces skeletal morbidity in women with advanced breast cancer and lytic bone lesions: a randomized, placebo-controlled trial. J Clin Oncol 1999; 17: 846-54
  18. Beasley CM, Sutton VK, Hamilton SH, et al. The olanzapine relapse prevention study group: a double-blind, randomized, placebo-controlled trial of olanzapine in the prevention of psychotic relapse. J Clin Psychopharmacol 2003; 23: 582-94
  19. Freemantle N, Calvert M, Wood J, et al. Composite outcomes in randomized trials: greater precision but with greater uncertainty? JAMA 2003; 289: 2554-9
  20. Cannon CP. Clinical perspectives on the use of composite endpoints. Control Clin Trials 1997; 18: 517-29
  21. Fox KAA, Poole-Wilson PA, Henderson RA, et al. Interventional versus conservative treatment for patients with unstable angina or non-ST-elevation myocardial infarction: the British Heart Foundation RITA 3 randomised trial. Lancet 2002; 360: 743-51
  22. The TIME Investigators. Trial of invasive versus medical therapy in elderly patients with chronic symptomatic coronary-artery disease (TIME): a randomised trial. Lancet 2001; 358: 951-7
  23. Torp-Pederson C, Moller M, Bloch-Thomsen P, et al. Dofetilide in patients with congestive heart failure and left ventricular dysfunction. N Engl J Med 1999; 341: 857-65
  24. Montori VM, Permanyer-Miralda G, Ferreira-Gonzalez I, et al. Validity of composite endpoints in clinical trials. BMJ 2005; 330: 594-6
  25. Lauer MS, Topol AJ. Clinical trials: multiple treatments, multiple end points, and multiple lessons. JAMA 2003; 289: 2575-7
  26. The ESPRIT Study Group. Aspirin plus dipyridamole versus aspirin alone after cerebral ischaemia of arterial origin (ESPRIT): randomised controlled trial. Lancet 2006; 367: 1665-73
  27. Cairns JA, Connolly SJ, Roberts R, et al. Randomised trial of outcome after myocardial infarction in patients with frequent or repetitive ventricular premature depolarisations: CAMIAT. Lancet 1997; 349: 675-82
  28. Gottlieb SS. Dead is dead: artificial definitions are no substitute. Lancet 1997; 349: 662-3
  29. Committee for Proprietary Medicinal Products (CPMP). Points to consider on multiplicity issues in clinical trials. CPMP/EWP/908/99. London, 19 Dec 2002 [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/ewp/ 090899en.pdf [Accessed 2007 Jan 23]
  30. Niewoehner DE, Erbland ML. Deupree RH, et al. Effect of systemic glucocorticoids on exacerbations of chronic obstructive pulmonary disease. N Engl J Med 1999; 340: 1941-7
  31. Echt DS, Liebson PR, Mitchell IB, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo: the cardiac arrhythmia suppression trial. N Engl J Med 1991; 324r 781-8
  32. Packer M, Colucci WS, Sackner-Bernstein JD, et al. Double-blind, placebo-controlled study of the effects of carvedilol in patients with moderate to severe heart failure: the PRECISE Trial. Circulation 1996; 94: 2793-9
  33. Lubsen J. Exercise testing as outcome in congestive heart failure trials: design considerations when interpreting results. Drugs 1994; 47: 25-30
  34. Pocock SJ. Clinical trials with multiple outcomes: a statistical perspective on their design, analysis, and interpretation. Control Clin Trials 1997; 18: 530-45
  35. UK Prospective Diabetes Study (UKPDS) Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998; 317: 703-13
  36. McGuire DK, Califf RM. Diabetes and cardiovascular disease: current opinions and future directions. Am Heart J 1999; 138 (5 Pt 1): S327-9
  37. FDA, Center for Drug Evaluation and Research (CDER) and Center for Biologies Evaluation and Research (CBER). Draft guidance for industry: clinical trial endpoints for the approval of cancer drugs and biologies. April 2005 [online]. Available from URL: http://www.fda.gov/cder/Guidance/6592dft.pdf [Accessed 2007 Jan 23]
  38. Johnson JR, Williams G, Pazdur R, et al. End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol 2003 ; 21: 1404-11
  39. Schulz KF, Grimes DA. Multiplicity in randomized trials 1: endpoints and treatments. Lancet 2005; 365: 1591-5
  40. Ferreira-Gonzalez I, Busse JW, Heels-Ansdell D, et al. Problems with the use of composite endpoints in cardiovascular trials: systematic review of randomised controlled trials. BMJ 2007; 334: 786-8
  41. Yudkin JS. The DREAM trial [comment]. Lancet 2006; 368: 2049-50
  42. Nissen SE. The DREAM trial [comment]. Lancet 2006; 368: 2049
  43. Hallstrom AP, Litwin PE, Weaver WD. A method of assigning scores to the components of a composite outcome: an example from the M1TI trial. Control Clin Trials 1992; 13: 148-55
  44. Neaton JD, Wentworth DN, Rhame F, et al. Considerations in choice of a clinical endpoint for AIDS clinical trials. Stat Med 1994; 13: 2107-25
  45. Bowden CL, Calabrese JR, McElroy SL, et al. A randomized, placebo-controlled 12-month trial of divalproex and lithium in treatment of outpatients with bipolar I disorder. Divalproex Maintenance Study Group. Gen Psychiatry 2000; 57: 481-9
  46. Bristow MR, Saxon LA, Boehmer J, et al. for the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med 2004; 350: 2140-50
  47. Brown MJ, Palmer CR, Castaigne A, et al. Morbidity and mortality in patients randomized to double-blind treatment with a long-acting calcium-channel blocker or diuretic in the International Nifedipine GITS study: Intervention as a Goal in Hypertension Treatment (INSIGHT). Lancet 2000; 356: 366-72
  48. Hansson L, Hedner T, Lund-Johansen P, et al. Randomised trial of effects of calcium antagonists compared with diuretics and beta-blockers on cardiovascu¬lar morbidity and mortality in hypertension: the Nordic Diltiazem (NORDIL) study. Lancet 2000; 356: 359-65
  49. Committee for Medicinal Products for Human Use (CHMP). Guideline on data monitoring committees: EMEA/CHMP/EWP/5872/03. London, 27 Jul 2005 [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/ewp/ 587203en.pdf [Accessed 2007 Jan 23]
  50. FDA, Center for Drug Evaluation and Research (CDER), Center for Biologies Evaluation and Research (CBER) and Center for Devices and Radiological Health (CDRH). Draft guidance for clinical trial sponsors. On the establishment and operation of clinical trial data monitoring committees. 2001 Nov [online]. Available from URL: http://http://www.fda.gov/cber/gdlns/clindatmon.pdf [Accessed 2007 Jan 23]
  51. The Thrombin Inhibition in Myocardial Ischemia (TRIM) Study Group. A low molecular weight, selective thrombin inhibitor, inogatran, vs heparin, in unsta¬ble coronary artery disease in 1209 patients: a double-blind, randomized, dose-finding study. Eur Heart J 1997; 18: 1416-25
  52. Naslund U, Grip L, Fischer-Hansen J, et al. The impact of an end-point committee in large multicentre, randomized, placebo-controlled clinical trial. Eur Heart J 1999; 20: 771-7
  53. Mahaffey KW, Roe MT, Dyke CK, et al. Second Platelet Hb/IIIa Antagonist for the Reduction of Acute Coronary Syndrome Events in a Global Organization Network Trial: misreporung of myocardial infarction end points: results of adjudication by a central clinical events committee in the PARAGON-B trial. Am Heart J 2002; 143: 242-8
  54. 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: 180-6
  55. Skyler JS. PROactive results overstated and misleading. DOC News 2005; 2: 4
  56. Charbonnel B, Dormandy J, Erdmann E, et al. The prospective pioglitazone clinical trial in macrovascular events (PROactive). Can pioglitazone reduce cardiovascular events in diabetes? Study design and baseline characteristics of 5.238 patients. Diabetes Care 2004; 27: 1647-53
  57. The PROactive Study Executive Committee and Data and Safety Monitoring Committee. PROactive study. Lancet 2006; 367: 982
  58. The EURopean trial On reduction of cardiac events with Perindopril in stable coronary Artery disease Investigators. Efficacy of perindopril in reduction of cardiovascular events among patients with stable coronary artery disease: randomised, double-blind, placebo-controlled, multicentre trial (the EUROPA study). Lancet 2003; 362: 782-8
  59. Montori VM, Guyatt GH. Intention-to-treat principle. CMAJ 2001; 165: 1339-41
  60. Skali H, Pfeffer MA, Lubsen J. Variable impact of combining fatal and nonfatal endpoints in heart failure trials. Circulation 2006; 114: 2298-303
  61. Lubsen J, Poole-Wilson PA. The DREAM trial [comment]. Lancet 2006; 368: 2050
  62. Bresalier RS, Sandler RS, Quan H, et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl 1 Med 2005; 352: 1092-102
  63. Lagakos SW. Time-to-event analyses for long-term treatments: the APPROVe Trial. N Engl J Med 2006; 355: 113-7
  64. Poole-Wilson PA, Lubsen J, Kirwan BA, et al. Effect of long-acting nifedipine on mortality and cardiovascular morbidity in patients with stable angina requiring treatment (ACTION trial): randomised controlled trial. Lancet 2004; 364: 849-57
  65. Hohnloser SH, Kuck KH, Dorian P, et al. Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction. N Engl J Med 2004; 351: 2481-8
  66. Chen YHJ, DeMets DL, Lan KKG. Monitoring mortality at interim analyses while testing a composite endpoint at the final analysis. Control Clin Trials 2003; 24: 16-27
  67. Packer M, Bristow MR, Cohn JN, et al. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. N Engl J Med 1996; 334: 1349-55
  68. Fisher LD, Moye LA. Carvedilol and the Food and Drug Administration (FDA) approval process: an introduction. Control Clin Trials 1999; 20: 1-15
  69. Fisher LD. Carvedilol and the Food and Drug Administration (FDA) approval process: the FDA paradigm and reflections on hypothesis testing. Control Clin Trials 1999; 20: 16-39
  70. Kleist P. Stopping a trial early for treatment benefit: pros and cons. Appl Clin Trials 2007; Jan: 34-7
  71. Montori VM, Devereaux PJ, Adhikari NKJ, et al. Randomized trials stopped for benefit: a systematic review. JAMA 2005; 294: 2203-9
  72. The CAPRICORN Investigators. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRIC randomised trial. Lancet 2001; 357: 1385-90
  73. Brown DL, Fann CSJ, Chang CJ. Effect of glycoprotein Hb/IIIa inhibitors с individual components of composite endpoints used in clinical trials of un: angina and non-Q-wave myocardial infarction. Cardiovasc Drugs Ther : 14: 253-8
  74. Freemantle N, Calvert M. Composite and surrogate outcomes in randomization controlled trials. BMJ 2007; 334: 75,6-7
  75. Le May MR, Labinaz M, Davies RF, et al. Stenting versus thrombolysis in myocardial infarction trial (STAT). J Am Coll Cardiol 2001; 37: 985-91
  76. Temple R. Multiple endpoints: statistical framework for clinical decision. Drug Information Association 39th Annual Meeting; 2003 Jun 15-19 Antonio (TX).
  77. Altman DG, Schulz KF, Moher D, et al. The revised CONSORT state me reporting randomized trials: explanation and elaboration. Ann Intern Med 134: 663-94

 

Похожие статьи