메뉴 건너뛰기




Volumn 105, Issue 5, 2005, Pages 1114-1118

Surrogate end points in clinical research: Hazardous to your health

Author keywords

[No Author keywords available]

Indexed keywords

MEDROXYPROGESTERONE ACETATE; ORAL CONTRACEPTIVE AGENT; PROTEIN C; SPERMICIDAL AGENT;

EID: 17644412369     PISSN: 00297844     EISSN: 1873233X     Source Type: Journal    
DOI: 10.1097/01.AOG.0000157445.67309.19     Document Type: Editorial
Times cited : (134)

References (38)
  • 1
    • 84970852560 scopus 로고
    • The scandal of poor medical research.
    • Altman DG. The scandal of poor medical research. BMJ 1994;308:283-4.
    • (1994) BMJ , vol.308 , pp. 283-4
    • Altman, D.G.1
  • 2
    • 0024520844 scopus 로고
    • Surrogate endpoints in clinical trials: definition and operational criteria.
    • Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 1989;8:431-40.
    • (1989) Stat Med , vol.8 , pp. 431-40
    • Prentice, R.L.1
  • 3
    • 0037066097 scopus 로고    scopus 로고
    • Clinical trial end points: on the road to nowhere?
    • Holloway RG, Dick AW. Clinical trial end points: on the road to nowhere? Neurology 2002;58:679-86.
    • (2002) Neurology , vol.58 , pp. 679-86
    • Holloway, R.G.1    Dick, A.W.2
  • 4
    • 0030268577 scopus 로고    scopus 로고
    • Surrogate end points in clinical trials: are we being misled?
    • Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med 1996;125:605-13.
    • (1996) Ann Intern Med , vol.125 , pp. 605-13
    • Fleming, T.R.1    DeMets, D.L.2
  • 5
    • 0003884301 scopus 로고    scopus 로고
    • Statistical issues in drug development.
    • Chichester, England, John Wiley & Sons
    • Senn S. Statistical issues in drug development. Chichester, England: John Wiley & Sons, 1997.
    • (1997)
    • Senn, S.1
  • 7
    • 0037603588 scopus 로고    scopus 로고
    • Potential pitfalls in the use of surrogate endpoints in colorectal adenoma chemoprevention.
    • Levin B. Potential pitfalls in the use of surrogate endpoints in colorectal adenoma chemoprevention. J Natl Cancer Inst 2003;95:697-9.
    • (2003) J Natl Cancer Inst , vol.95 , pp. 697-9
    • Levin, B.1
  • 8
    • 0036372284 scopus 로고    scopus 로고
    • The promise and peril of surrogate end points in cancer research.
    • Schatzkin A, Gail M. The promise and peril of surrogate end points in cancer research. Nat Rev Cancer 2002;2:19-27.
    • (2002) Nat Rev Cancer , vol.2 , pp. 19-27
    • Schatzkin, A.1    Gail, M.2
  • 9
    • 2942720882 scopus 로고    scopus 로고
    • A perfect correlate does not a surrogate make.
    • Baker SG, Kramer BS. A perfect correlate does not a surrogate make. BMC Med Res Methodol 2003;3:16.
    • (2003) BMC Med Res Methodol , vol.3 , pp. 16
    • Baker, S.G.1    Kramer, B.S.2
  • 10
    • 0026011647 scopus 로고
    • Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial.
    • Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med 1991;324:781-8.
    • (1991) N Engl J Med , vol.324 , pp. 781-8
    • Echt, D.S.1    Liebson, P.R.2    Mitchell, L.B.3    Peters, R.W.4    Obias-Manno, D.5    Barker, A.H.6
  • 12
    • 0037125379 scopus 로고    scopus 로고
    • Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial.
    • Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA 2002;288:321-33.
    • (2002) JAMA , vol.288 , pp. 321-33
  • 13
    • 0018838168 scopus 로고
    • W.H.O. cooperative trial on primary prevention of ischaemic heart disease using clofibrate to lower serum cholesterol: mortality follow-up. Report of the Committee of Principal Investigators.
    • W.H.O. cooperative trial on primary prevention of ischaemic heart disease using clofibrate to lower serum cholesterol: mortality follow-up. Report of the Committee of Principal Investigators. Lancet 1980;2:379-85.
    • (1980) Lancet , vol.2 , pp. 379-85
  • 14
    • 0030853952 scopus 로고    scopus 로고
    • A randomized controlled trial of epoprostenol therapy for severe congestive heart failure: The Flolan International Randomized Survival Trial (FIRST).
    • Califf RM, Adams KF, McKenna WJ, Gheorghiade M, Uretsky BF, McNulty SE, et al. A randomized controlled trial of epoprostenol therapy for severe congestive heart failure: The Flolan International Randomized Survival Trial (FIRST). Am Heart J 1997;134:44-54.
    • (1997) Am Heart J , vol.134 , pp. 44-54
    • Califf, R.M.1    Adams, K.F.2    McKenna, W.J.3    Gheorghiade, M.4    Uretsky, B.F.5    McNulty, S.E.6
  • 15
    • 8244241095 scopus 로고    scopus 로고
    • Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure. Second Prospective Randomised Study of Ibopamine on Mortality and Efficacy (PRIME II) Investigators.
    • Hampton JR, van Veldhuisen DJ, Kleber FX, Cowley AJ, Ardia A, Block P, et al. Randomised study of effect of ibopamine on survival in patients with advanced severe heart failure. Second Prospective Randomised Study of Ibopamine on Mortality and Efficacy (PRIME II) Investigators. Lancet 1997;349:971-7.
    • (1997) Lancet , vol.349 , pp. 971-7
    • Hampton, J.R.1    van Veldhuisen, D.J.2    Kleber, F.X.3    Cowley, A.J.4    Ardia, A.5    Block, P.6
  • 16
    • 0034566014 scopus 로고    scopus 로고
    • The Cochrane Library, Issue 4
    • Fluoride for treating postmenopausal osteoporosis (Cochrane Review)., Oxford, Update Software
    • Haguenauer D, Welch V, Shea B, Tugwell P, Wells G. Fluoride for treating postmenopausal osteoporosis (Cochrane Review). In: The Cochrane Library, Issue 4, 2000. Oxford: Update Software.
    • (2000)
    • Haguenauer, D.1    Welch, V.2    Shea, B.3    Tugwell, P.4    Wells, G.5
  • 17
    • 0018824204 scopus 로고
    • Effects of contraceptive steroids on serum lipoproteins and cardiovascular disease scrutinized at workshop in Bethesda.
    • Baggett B, Nash HA. Effects of contraceptive steroids on serum lipoproteins and cardiovascular disease scrutinized at workshop in Bethesda. Contraception 1980;21:115-20.
    • (1980) Contraception , vol.21 , pp. 115-20
    • Baggett, B.1    Nash, H.A.2
  • 18
    • 0032547326 scopus 로고    scopus 로고
    • 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.
    • Hulley S, Grady D, Bush T, Furberg C, Herrington D, Riggs B, et al. 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;280:605-13.
    • (1998) JAMA , vol.280 , pp. 605-13
    • Hulley, S.1    Grady, D.2    Bush, T.3    Furberg, C.4    Herrington, D.5    Riggs, B.6
  • 19
    • 77957126077 scopus 로고
    • Effects of estrogen or estrogen/progestin regimens on heart disease risk factors in postmenopausal women. The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial.
    • The Writing Group for the PEPI Trial. Effects of estrogen or estrogen/progestin regimens on heart disease risk factors in postmenopausal women. The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. JAMA 1995;273:199-208.
    • (1995) JAMA , vol.273 , pp. 199-208
  • 20
    • 0003880266 scopus 로고
    • Clinical epidemiology: a basic science for clinical medicine. 2nd ed.
    • Boston (MA), Little, Brown and Company
    • Sackett DL, Haynes RB, Guyatt GH, Tugwell P. Clinical epidemiology: a basic science for clinical medicine. 2nd ed. Boston (MA): Little, Brown and Company; 1991.
    • (1991)
    • Sackett, D.L.1    Haynes, R.B.2    Guyatt, G.H.3    Tugwell, P.4
  • 21
    • 0033386923 scopus 로고    scopus 로고
    • The public health implications of the 1995 “pill scare”.
    • Furedi A. The public health implications of the 1995 “pill scare”. Hum Reprod Update 1999;5:621-6.
    • (1999) Hum Reprod Update , vol.5 , pp. 621-6
    • Furedi, A.1
  • 22
    • 0027015314 scopus 로고
    • The androgenicity of oral contraceptives: the young patient’s concerns.
    • Runnebaum B. The androgenicity of oral contraceptives: the young patient’s concerns. Int J Fertil 1992;37(suppl 4):211-7.
    • (1992) Int J Fertil , vol.37 , pp. 211-7
    • Runnebaum, B.1
  • 23
    • 85026177312 scopus 로고    scopus 로고
    • Stedman’s Medical Dictionary. 27th edition.
    • Philadelphia (PA), Lippincott Williams & Wilkins
    • Stedman’s Medical Dictionary. 27th edition. Philadelphia (PA): Lippincott Williams & Wilkins; 2000.
    • (2000)
  • 24
    • 0025246101 scopus 로고
    • Effects of seven low-dose combined oral contraceptives on sex hormone binding globulin, corticosteroid binding globulin, total and free testosterone.
    • van der Vange N, Blankenstein MA, Kloosterboer HJ, Haspels AA, Thijssen JH. Effects of seven low-dose combined oral contraceptives on sex hormone binding globulin, corticosteroid binding globulin, total and free testosterone. Contraception 1990;41:345-52.
    • (1990) Contraception , vol.41 , pp. 345-52
    • van der Vange, N.1    Blankenstein, M.A.2    Kloosterboer, H.J.3    Haspels, A.A.4    Thijssen, J.H.5
  • 25
    • 0036280119 scopus 로고    scopus 로고
    • Can changes in sex hormone binding globulin predict the risk of venous thromboembolism with combined oral contraceptive pills?
    • Odlind V, Milsom I, Persson I, Victor A. Can changes in sex hormone binding globulin predict the risk of venous thromboembolism with combined oral contraceptive pills? Acta Obstet Gynecol Scand 2002;81:482-90.
    • (2002) Acta Obstet Gynecol Scand , vol.81 , pp. 482-90
    • Odlind, V.1    Milsom, I.2    Persson, I.3    Victor, A.4
  • 26
    • 1342324129 scopus 로고    scopus 로고
    • Sex hormone-binding globulin: a surrogate marker for the prothrombotic effects of combined oral contraceptives.
    • van Rooijen M, Silveira A, Hamsten A, Bremme K. Sex hormone-binding globulin: a surrogate marker for the prothrombotic effects of combined oral contraceptives. Am J Obstet Gynecol 2004;190:332-7.
    • (2004) Am J Obstet Gynecol , vol.190 , pp. 332-7
    • van Rooijen, M.1    Silveira, A.2    Hamsten, A.3    Bremme, K.4
  • 27
    • 0020040466 scopus 로고
    • Oral contraceptives and blood coagulation: a critical review.
    • Mammen EF. Oral contraceptives and blood coagulation: a critical review. Am J Obstet Gynecol 1982;142:781-90.
    • (1982) Am J Obstet Gynecol , vol.142 , pp. 781-90
    • Mammen, E.F.1
  • 28
    • 0032034138 scopus 로고    scopus 로고
    • Blood coagulation and oral contraceptives: a critical review.
    • Winkler UH. Blood coagulation and oral contraceptives: a critical review. Contraception 1998;57:203-9.
    • (1998) Contraception , vol.57 , pp. 203-9
    • Winkler, U.H.1
  • 29
    • 0031424592 scopus 로고    scopus 로고
    • Thrombophilic mechanisms of OCs.
    • Comp PC. Thrombophilic mechanisms of OCs. Int J Fertil Womens Med 1997;suppl 1:170-6.
    • (1997) Int J Fertil Womens Med , pp. 170-6
    • Comp, P.C.1
  • 30
    • 0029990546 scopus 로고    scopus 로고
    • Sperm transport and survival post-application of a new spermicide contraceptive. Advantage 24 Study Group.
    • Sangi-Haghpeykar H, Poindexter AN 3rd, Levine H. Sperm transport and survival post-application of a new spermicide contraceptive. Advantage 24 Study Group. Contraception 1996;53:353-6.
    • (1996) Contraception , vol.53 , pp. 353-6
    • Sangi-Haghpeykar, H.1    Poindexter, A.N.2    Levine, H.3
  • 33
    • 0142091087 scopus 로고    scopus 로고
    • Clinical breakage, slippage and acceptability of a new commercial polyurethane condom: a randomized, controlled study.
    • Potter WD, de Villemeur M. Clinical breakage, slippage and acceptability of a new commercial polyurethane condom: a randomized, controlled study. Contraception 2003;68:39-45.
    • (2003) Contraception , vol.68 , pp. 39-45
    • Potter, W.D.1    de Villemeur, M.2
  • 35
    • 0037338168 scopus 로고    scopus 로고
    • Contraceptive effectiveness of a polyurethane condom and a latex condom: a randomized controlled trial.
    • Steiner MJ, Dominik R, Rountree RW, Nanda K, Dorflinger LJ. Contraceptive effectiveness of a polyurethane condom and a latex condom: a randomized controlled trial. Obstet Gynecol 2003;101:539-47.
    • (2003) Obstet Gynecol , vol.101 , pp. 539-47
    • Steiner, M.J.1    Dominik, R.2    Rountree, R.W.3    Nanda, K.4    Dorflinger, L.J.5
  • 36
    • 85026176354 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration. Black box warning added concerning long-term use of Depo-Provera contraceptive injection. FDA Talk Paper T04-50: November 17, 2004. Available at: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01325.html. Retrieved January 31, 2005.
    • U.S. Food and Drug Administration. Black box warning added concerning long-term use of Depo-Provera contraceptive injection. FDA Talk Paper T04-50: November 17, 2004. Available at: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01325.html. Retrieved January 31, 2005.
  • 38
    • 1542720639 scopus 로고    scopus 로고
    • Is bone mineral density predictive of fracture risk reduction?
    • Cefalu CA. Is bone mineral density predictive of fracture risk reduction? Curr Med Res Opin 2004;20:341-9.
    • (2004) Curr Med Res Opin , vol.20 , pp. 341-9
    • Cefalu, C.A.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.