메뉴 건너뛰기




Volumn 29, Issue 10, 2010, Pages 1842-1848

Designing comparative effectiveness research on prescription drugs: Lessons from the clinical trial literature

Author keywords

[No Author keywords available]

Indexed keywords

PRESCRIPTION DRUG;

EID: 79952115940     PISSN: 02782715     EISSN: 15445208     Source Type: Journal    
DOI: 10.1377/hlthaff.2010.0843     Document Type: Article
Times cited : (19)

References (55)
  • 1
    • 84872249703 scopus 로고    scopus 로고
    • Institute of Medicine. Initial national priorities for comparative effectiveness research. Washington (DC): National Academies Press
    • Institute of Medicine. Initial national priorities for comparative effectiveness research. Washington (DC): National Academies Press; 2009.
    • (2009)
  • 2
    • 70349914121 scopus 로고    scopus 로고
    • Using effectiveness and cost-effectiveness to make drug coverage decisions: a comparison of Britain, Australia, and Canada
    • Clement FM, Harris A, Li JJ, Yong K, Lee KM, Manns BJ. Using effectiveness and cost-effectiveness to make drug coverage decisions: a comparison of Britain, Australia, and Canada. JAMA. 2009;302(13):1437-43.
    • (2009) JAMA , vol.302 , Issue.3 , pp. 1437-1443
    • Clement, F.M.1    Harris, A.2    Li, J.J.3    Yong, K.4    Lee, K.M.5    Manns, B.J.6
  • 3
    • 77949331904 scopus 로고    scopus 로고
    • Characteristics of published comparative effectiveness studies of medications
    • Hochman M, McCormick D. Characteristics of published comparative effectiveness studies of medications. JAMA. 2010;303(10):951-8.
    • (2010) JAMA , vol.303 , Issue.10 , pp. 951-958
    • Hochman, M.1    Mccormick, D.2
  • 4
    • 84872225625 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Federal Coordinating Council for Comparative Effectiveness Research. Report to the president and the Congress. Washington (DC): HHS
    • US Department of Health and Human Services, Federal Coordinating Council for Comparative Effectiveness Research. Report to the president and the Congress. Washington (DC): HHS; 2009.
    • (2009)
  • 5
    • 68249103874 scopus 로고    scopus 로고
    • Comparative effectiveness research: a report from the Institute of Medicine
    • Sox HC, Greenfield S. Comparative effectiveness research: a report from the Institute of Medicine. Ann Intern Med. 2009;151(3):203-5.
    • (2009) Ann Intern Med. , vol.151 , Issue.3 , pp. 203-205
    • Sox, H.C.1    Greenfield, S.2
  • 6
    • 84872238839 scopus 로고    scopus 로고
    • To access the Appendix, click on the Appendix link in the box to the right of the article online
    • To access the Appendix, click on the Appendix link in the box to the right of the article online.
  • 7
    • 84872256375 scopus 로고    scopus 로고
    • Joint National Committee. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Bethesda (MD): National Heart, Lung, and Blood Institute
    • Joint National Committee. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Bethesda (MD): National Heart, Lung, and Blood Institute; 1997.
    • (1997)
  • 8
    • 0032540714 scopus 로고    scopus 로고
    • Are beta-blockers efficacious as first-line therapy for hypertension in the elderly? A systematic review
    • Messerli FH, Grossman E, Goldbourt U. Are beta-blockers efficacious as first-line therapy for hypertension in the elderly? A systematic review. JAMA. 1998;279(23):1903-7.
    • (1998) JAMA , vol.279 , Issue.23 , pp. 1903-1907
    • Messerli, F.H.1    Grossman, E.2    Goldbourt, U.3
  • 9
    • 24644443331 scopus 로고    scopus 로고
    • Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA)
    • Dahlof B, Sever PS, Poulter NR, Wedel H, Beevers DG, Caulfield M, et al. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA). Lancet. 2005;366(9489):895-906.
    • (2005) Lancet. , vol.366 , Issue.9489 , pp. 895-906
    • Dahlof, B.1    Sever, P.S.2    Poulter, N.R.3    Wedel, H.4    Beevers, D.G.5    Caulfield, M.6
  • 10
    • 33645735800 scopus 로고    scopus 로고
    • Recent trials in hypertension: compelling science or commercial speech?
    • Psaty BM, Weiss NS, Furberg CD. Recent trials in hypertension: compelling science or commercial speech? JAMA. 2006;295(14): 1704-6.
    • (2006) JAMA , vol.295 , Issue.14 , pp. 1704-1706
    • Psaty, B.M.1    Weiss, N.S.2    Furberg, C.D.3
  • 12
    • 33750944984 scopus 로고    scopus 로고
    • Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Longterm (MEDAL) programme
    • Cannon CP, Curtis SP, FitzGerald GA, Krum H, Kaur A, Bolognese JA, et al. Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Longterm (MEDAL) programme. Lancet. 2006;368(9549):1771-81.
    • (2006) Lancet. , vol.368 , Issue.9549 , pp. 1771-1781
    • Cannon, C.P.1    Curtis, S.P.2    Fitzgerald, G.A.3    Krum, H.4    Kaur, A.5    Bolognese, J.A.6
  • 13
    • 33749339372 scopus 로고    scopus 로고
    • Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2
    • McGettigan P, Henry D. Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA. 2006; 296(13):1633-44.
    • (2006) JAMA , vol.296 , Issue.13 , pp. 1633-1644
    • Mcgettigan, P.1    Henry, D.2
  • 14
    • 33744976771 scopus 로고    scopus 로고
    • Do selective cyclo-oxygenase-2 inhibitors and traditional nonsteroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials
    • Kearney PM, Baigent C, Godwin J, Halls H, Emberson JR, Patrono C. Do selective cyclo-oxygenase-2 inhibitors and traditional nonsteroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ. 2006;332(7553): 1302-8.
    • (2006) BMJ. , vol.332 , Issue.7553 , pp. 1302-1308
    • Kearney, P.M.1    Baigent, C.2    Godwin, J.3    Halls, H.4    Emberson, J.R.5    Patrono, C.6
  • 15
    • 34547958547 scopus 로고    scopus 로고
    • Keeping science on top in drug evaluation
    • Avorn J. Keeping science on top in drug evaluation. N Engl J Med. 2007;357(7):633-5.
    • (2007) N Engl J Med. , vol.357 , Issue.7 , pp. 633-635
    • Avorn, J.1
  • 16
    • 84872251423 scopus 로고    scopus 로고
    • Food and Drug Administration, Center for Drug Evaluation and Re-search. Joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Washington (DC): FDA;
    • Food and Drug Administration, Center for Drug Evaluation and Re-search. Joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Volume III. Washington (DC): FDA; 2005.
    • (2005) , vol.3
  • 17
    • 84872243519 scopus 로고    scopus 로고
    • Food and Drug Administration, Center for Drug Evaluation and Research. Transcript of Arthritis Advisory Committee Meeting. Washington (DC): FDA, Apr 12.
    • Food and Drug Administration, Center for Drug Evaluation and Research. Transcript of Arthritis Advisory Committee Meeting. Washington (DC): FDA; 2007 Apr 12.
    • (2007)
  • 18
    • 62249093192 scopus 로고    scopus 로고
    • Reassessing the validity of surrogate markers of drug efficacy in the treatment of coronary artery disease
    • Colatsky TJ. Reassessing the validity of surrogate markers of drug efficacy in the treatment of coronary artery disease. Curr Opin Investig Drugs. 2009;10(3):239-44.
    • (2009) Curr Opin Investig Drugs. , vol.10 , Issue.3 , pp. 239-244
    • Colatsky, T.J.1
  • 19
    • 0027370108 scopus 로고
    • The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus
    • The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329(14): 977-86.
    • (1993) N Engl J Med. , vol.329 , Issue.14 , pp. 977-986
  • 20
    • 67149146438 scopus 로고    scopus 로고
    • Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial
    • Home PD, Pocock SJ, Beck-Nielsen H, Curtis PS, Gomis R, Hanefeld M, et al. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet. 2009;373(9681):2125-35.
    • (2009) Lancet. , vol.373 , Issue.9681 , pp. 2125-2135
    • Home, P.D.1    Pocock, S.J.2    Beck-Nielsen, H.3    Curtis, P.S.4    Gomis, R.5    Hanefeld, M.6
  • 21
    • 84872255127 scopus 로고    scopus 로고
    • FDA memorandum: cardiovascular events in RECORD, NDA 21-071/S-035 [Internet]. Rockville (MD): Food and Drug Administration, Jun 14 [cited 2010 Sep 13]. Available from:
    • Marciniak TA. FDA memorandum: cardiovascular events in RECORD, NDA 21-071/S-035 [Internet]. Rockville (MD): Food and Drug Administration; 2010 Jun 14 [cited 2010 Sep 13]. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM218493.pdf
    • (2010)
    • Marciniak, T.A.1
  • 22
    • 34250212715 scopus 로고    scopus 로고
    • Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes
    • Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007;356(24):2457-71.
    • (2007) N Engl J Med. , vol.356 , Issue.24 , pp. 2457-2471
    • Nissen, S.E.1    Wolski, K.2
  • 24
    • 41149128233 scopus 로고    scopus 로고
    • Surrogate end points and FDA approval: a tale of 2 lipid-altering drugs
    • Psaty BM, Lumley T. Surrogate end points and FDA approval: a tale of 2 lipid-altering drugs. JAMA. 2008; 299(12):1474-6.
    • (2008) JAMA , vol.299 , Issue.12 , pp. 1474-1476
    • Psaty, B.M.1    Lumley, T.2
  • 25
    • 65649154002 scopus 로고    scopus 로고
    • The neglected purpose of comparative-effectiveness research
    • Naik AD, Petersen LA. The neglected purpose of comparative-effectiveness research. N Engl J Med. 2009; 360(19):1929-31.
    • (2009) N Engl J Med. , vol.360 , Issue.19 , pp. 1929-1931
    • Naik, A.D.1    Petersen, L.A.2
  • 26
    • 0033517302 scopus 로고    scopus 로고
    • The effect of spironolactone on morbidity and mortality in patients with severe heart failure: Randomized Aldactone Evaluation Study Investigators
    • Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure: Randomized Aldactone Evaluation Study Investigators. N Engl J Med. 1999;341(10): 709-17.
    • (1999) N Engl J Med. , vol.341 , Issue.10 , pp. 709-717
    • Pitt, B.1    Zannad, F.2    Remme, W.J.3    Cody, R.4    Castaigne, A.5    Perez, A.6
  • 27
    • 3442886513 scopus 로고    scopus 로고
    • Rates of hyperkalemia after publication of the Randomized Aldactone Evaluation Study
    • Juurlink DN, Mamdani MM, Lee DS, Kopp A, Austin PC, Laupacis A, et al. Rates of hyperkalemia after publication of the Randomized Aldactone Evaluation Study. N Engl J Med. 2004;351(6):543-51.
    • (2004) N Engl J Med. , vol.351 , Issue.6 , pp. 543-551
    • Juurlink, D.N.1    Mamdani, M.M.2    Lee, D.S.3    Kopp, A.4    Austin, P.C.5    Laupacis, A.6
  • 28
    • 34247106224 scopus 로고    scopus 로고
    • Clinical trials in the elderly-a concept comes of age
    • Siu LL. Clinical trials in the elderly-a concept comes of age. N Engl J Med. 2007;356(15):1575-6.
    • (2007) N Engl J Med. , vol.356 , Issue.15 , pp. 1575-1576
    • Siu, L.L.1
  • 29
    • 68549110395 scopus 로고    scopus 로고
    • Under-representation of women in high-impact published clinical cancer research
    • Jagsi R, Motomura AR, Amarnath S, Jankovic A, Sheets N, Ubel PA. Under-representation of women in high-impact published clinical cancer research. Cancer. 2009; 115(14):3293-301.
    • (2009) Cancer. , vol.115 , Issue.14 , pp. 3293-3301
    • Jagsi, R.1    Motomura, A.R.2    Amarnath, S.3    Jankovic, A.4    Sheets, N.5    Ubel, P.A.6
  • 30
    • 0141684982 scopus 로고    scopus 로고
    • Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy
    • Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290(12): 1624-32.
    • (2003) JAMA , vol.290 , Issue.12 , pp. 1624-1632
    • Tunis, S.R.1    Stryer, D.B.2    Clancy, C.M.3
  • 31
    • 84872233249 scopus 로고    scopus 로고
    • Center for Medicine in the Public Interest. ALLHAT and CATIE reconsidered: reflections on big studies and evidence based medicine as the measure of comparative effectiveness. New York (NY): The Center
    • Center for Medicine in the Public Interest. ALLHAT and CATIE reconsidered: reflections on big studies and evidence based medicine as the measure of comparative effectiveness. New York (NY): The Center; 2007.
    • (2007)
  • 32
    • 0344373794 scopus 로고    scopus 로고
    • Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)
    • Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002;288(23):2981-97.
    • (2002) JAMA , vol.288 , Issue.23 , pp. 2981-97
  • 33
    • 0037357939 scopus 로고    scopus 로고
    • The ALLHAT study: if you believe in evidence-based medicine, stick to it! J Hypertension
    • Julius S. The ALLHAT study: if you believe in evidence-based medicine, stick to it! J Hypertension. 2003; 21:453-4.
    • (2003) , vol.21 , pp. 453-454
    • Julius, S.1
  • 34
    • 0346250908 scopus 로고    scopus 로고
    • Guidelines for antihypertensive treatment: an update after the ALLHAT study
    • Salvetti A, Ghiadoni L. Guidelines for antihypertensive treatment: an update after the ALLHAT study. J Am Soc Nephrol. 2004;15:S51-4.
    • (2004) J Am Soc Nephrol. , vol.15
    • Salvetti, A.1    Ghiadoni, L.2
  • 35
    • 84872253159 scopus 로고    scopus 로고
    • The minimal impact of a big hypertension study. New York Times, Nov 27
    • Pollack A. The minimal impact of a big hypertension study. New York Times. 2008 Nov 27:B1.
    • (2008) , vol.B1
    • Pollack, A.1
  • 37
    • 66749112971 scopus 로고    scopus 로고
    • Improving mental health treatments through comparative effectiveness research
    • Wang PS, Ulbricht CM, Schoenbaum M. Improving mental health treatments through comparative effectiveness research. Health Aff (Millwood). 2009;28(3):783-91.
    • (2009) Health Aff (Millwood). , vol.28 , Issue.3 , pp. 783-791
    • Wang, P.S.1    Ulbricht, C.M.2    Schoenbaum, M.3
  • 38
    • 50149121484 scopus 로고    scopus 로고
    • NAMI perspective on CATIE: policy and research implications
    • Duckworth K, Fitzpatrick MJ. NAMI perspective on CATIE: policy and research implications. Psychiatr Serv. 2008;59(5):537-9.
    • (2008) Psychiatr Serv. , vol.59 , Issue.5 , pp. 537-539
    • Duckworth, K.1    Fitzpatrick, M.J.2
  • 39
    • 84863223096 scopus 로고    scopus 로고
    • Drug makers are advocacy group's biggest donors
    • Harris G. Drug makers are advocacy group's biggest donors. New York Times. 2009 Oct 21:A23.
    • (2009) New York Times. , vol.21
    • Harris, G.1
  • 40
    • 0038075468 scopus 로고    scopus 로고
    • A randomized trial comparing lungvolume-reduction surgery with medical therapy for severe emphysema
    • Fishman A, Martinez F, Naunheim K, Piantadosi S, Wise R, Ries A, et al. A randomized trial comparing lungvolume-reduction surgery with medical therapy for severe emphysema. N Engl J Med. 2003; 348(21):2059-73.
    • (2003) N Engl J Med. , vol.348 , Issue.21 , pp. 2059-2073
    • Fishman, A.1    Martinez, F.2    Naunheim, K.3    Piantadosi, S.4    Wise, R.5    Ries, A.6
  • 41
    • 12844280744 scopus 로고    scopus 로고
    • Using clinical trials as a condition of coverage: lessons from the National Emphysema Treatment Trial
    • Carino T, Sheingold S, Tunis S. Using clinical trials as a condition of coverage: lessons from the National Emphysema Treatment Trial. Clin Trials. 2004;1(1):108-21.
    • (2004) Clin Trials. , vol.1 , Issue.1 , pp. 108-121
    • Carino, T.1    Sheingold, S.2    Tunis, S.3
  • 42
    • 33644939601 scopus 로고    scopus 로고
    • Medicare says it will pay, but patients say "no thanks."
    • Mar 3.
    • Kolata G. Medicare says it will pay, but patients say "no thanks." New York Times. 2006 Mar 3.
    • (2006) New York Times
    • Kolata, G.1
  • 43
    • 79951684079 scopus 로고    scopus 로고
    • Why observational studies should be among the tools used in comparative effectiveness research
    • Dreyer NA, Tunis SR, Berger M, Ollendorf D, Mattox P, Gliklich R. Why observational studies should be among the tools used in comparative effectiveness research. Health Aff (Millwood). 2010;29(10):1818-25.
    • (2010) Health Aff (Millwood). , vol.29 , Issue.10 , pp. 1818-1825
    • Dreyer, N.A.1    Tunis, S.R.2    Berger, M.3    Ollendorf, D.4    Mattox, P.5    Gliklich, R.6
  • 44
    • 79952116758 scopus 로고    scopus 로고
    • The critical role of observational evidence in comparative effectiveness research
    • Fleurence R, Naci H, Jansen JP. The critical role of observational evidence in comparative effectiveness research. Health Aff (Millwood). 2010;29(10):1826-33
    • (2010) Health Aff (Millwood). , vol.29 , Issue.10 , pp. 1826-1833
    • Fleurence, R.1    Naci, H.2    Jansen, J.P.3
  • 47
    • 77956088537 scopus 로고    scopus 로고
    • Adaptive clinical trial design: has its time come?
    • Epub ahead of print
    • Nelson NJ. Adaptive clinical trial design: has its time come? JNCI. 2010. Epub ahead of print.
    • (2010) JNCI.
    • Nelson, N.J.1
  • 49
    • 84872242289 scopus 로고    scopus 로고
    • Congressional Budget Office. Research on the comparative effectiveness of medical treatments. Washington (DC): CBO
    • Congressional Budget Office. Research on the comparative effectiveness of medical treatments. Washington (DC): CBO; 2007.
    • (2007)
  • 50
    • 36549040492 scopus 로고    scopus 로고
    • In defense of pharmacoepidemiology-embracing the yin and yang of drug research
    • Avorn J. In defense of pharmacoepidemiology-embracing the yin and yang of drug research. N Engl J Med. 2007;357(22):2219-21.
    • (2007) N Engl J Med. , vol.357 , Issue.22 , pp. 2219-2221
    • Avorn, J.1
  • 51
    • 0037199837 scopus 로고    scopus 로고
    • Network meta-analysis for indirect treatment comparisons
    • Lumley T. Network meta-analysis for indirect treatment comparisons. Stat Med. 2002;21(16):2313-24.
    • (2002) Stat Med. , vol.21 , Issue.16 , pp. 2313-2324
    • Lumley, T.1
  • 52
    • 63349088318 scopus 로고    scopus 로고
    • Coronary artery bypass surgery compared with percutaneous coronary interventions for multivessel disease
    • Hlatky MA, Boothroyd DB, Bravata DM, Boersma E, Booth J, Brooks MM, et al. Coronary artery bypass surgery compared with percutaneous coronary interventions for multivessel disease. Lancet. 2009;373(9670):1190-7.
    • (2009) Lancet. , vol.373 , Issue.9670 , pp. 1190-1197
    • Hlatky, M.A.1    Boothroyd, D.B.2    Bravata, D.M.3    Boersma, E.4    Booth, J.5    Brooks, M.M.6
  • 55
    • 41649106758 scopus 로고    scopus 로고
    • Does ENHANCE diminish confidence in lowering LDL or in ezetimibe?
    • Brown BG, Taylor AJ. Does ENHANCE diminish confidence in lowering LDL or in ezetimibe? N Engl J Med. 2008;358(14):1504-7.
    • (2008) N Engl J Med. , vol.358 , Issue.14 , pp. 1504-1507
    • Brown, B.G.1    Taylor, A.J.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.