메뉴 건너뛰기




Volumn 31, Issue 25, 2012, Pages 2944-2954

Current development in clinical trials: Issues old and new

Author keywords

Adaptive design; Noninferiority design; Randomized trials; Surrogate markers

Indexed keywords

ADAPTIVE TRIAL; ARTICLE; CLINICAL EVALUATION; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); COMPARATIVE EFFECTIVENESS; GENETICS; GENOMICS; GOLD STANDARD; HUMAN; INFORMATION PROCESSING; INFORMATIVE CENSORING; MEDICAL PRACTICE; NONINFERIORITY TRIAL; PATIENT CARE; RISK ASSESSMENT; STATISTICAL CONCEPTS; STUDY DESIGN; TYPES OF STUDY;

EID: 84867468040     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.5405     Document Type: Article
Times cited : (7)

References (39)
  • 2
    • 0025121261 scopus 로고
    • Early methodological developments for clinical trials at the National Heart, Lung, and Blood Institute
    • Halperin M, DeMets DL, Ware JH. Early methodological developments for clinical trials at the National Heart, Lung, and Blood Institute. Statistics in Medicine 1990; 9:881-892.
    • (1990) Statistics in Medicine , vol.9 , pp. 881-892
    • Halperin, M.1    DeMets, D.L.2    Ware, J.H.3
  • 4
    • 33745929924 scopus 로고    scopus 로고
    • Time-to-event analysis for long term prevention trials - the APPROVe trial
    • Lagakos SW. Time-to-event analysis for long term prevention trials - the APPROVe trial. New England Journal of Medicine 2006; 355:113-117.
    • (2006) New England Journal of Medicine , vol.355 , pp. 113-117
    • Lagakos, S.W.1
  • 6
    • 0034687072 scopus 로고    scopus 로고
    • Placebo-controlled trials and active-control in the evaluation of new treatments. Part 1: ethical and scientific issues
    • Temple R, Ellenberg SS. Placebo-controlled trials and active-control in the evaluation of new treatments. Part 1: ethical and scientific issues. Annals of Internal Medicine 2000; 133:455-463.
    • (2000) Annals of Internal Medicine , vol.133 , pp. 455-463
    • Temple, R.1    Ellenberg, S.S.2
  • 7
    • 15244357900 scopus 로고    scopus 로고
    • A regulatory perspective on choice of margin and statistical inference issue in non-inferiority trials
    • Hung HM, Wang SJ, O'Neill R. A regulatory perspective on choice of margin and statistical inference issue in non-inferiority trials. Biometrical Journal 2005; 47:28-36.
    • (2005) Biometrical Journal , vol.47 , pp. 28-36
    • Hung, H.M.1    Wang, S.J.2    O'Neill, R.3
  • 8
    • 38949173080 scopus 로고    scopus 로고
    • Current issues in non-inferiority trials
    • Fleming TR. Current issues in non-inferiority trials. Statistics in Medicine 2008; 27:317-332.
    • (2008) Statistics in Medicine , vol.27 , pp. 317-332
    • Fleming, T.R.1
  • 11
    • 84867442045 scopus 로고    scopus 로고
    • Cook T, DeMets DL (eds). Chapman & Hall/CRC; Taylor & Francis Group, LLC: Boca Raton, FL
    • Cook T, DeMets DL (eds). Introduction to Statistical Methods for Clinical Trials. Chapman & Hall/CRC; Taylor & Francis Group, LLC: Boca Raton, FL, 2008. p. 87.
    • (2008) Introduction to Statistical Methods for Clinical Trials , pp. 87
  • 12
    • 0030668967 scopus 로고    scopus 로고
    • Rationale, design, and organization of the metoprolol CR/XL randomized intervention trial in heart failure (MERIT-HF)
    • The International Steering Committee on Behalf of the MERIT-HF Study Group.
    • The International Steering Committee on Behalf of the MERIT-HF Study Group. Rationale, design, and organization of the metoprolol CR/XL randomized intervention trial in heart failure (MERIT-HF). American Journal of Cardiology 1997; 30(9B):54J-58J.
    • (1997) American Journal of Cardiology , vol.30 , Issue.9 B
  • 14
    • 0033514046 scopus 로고    scopus 로고
    • The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): A randomized trial
    • CIBIS-II Investigators and Committees.
    • CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): A randomized trial. Lancet 1999; 353:9-13.
    • (1999) Lancet , vol.353 , pp. 9-13
  • 15
    • 0021810226 scopus 로고
    • Intravenous and intracoronary fibronolytic therapy in acute myocardial infarction: overview of results on mortality, reinfarction and side-effects from 33randomized controlled trials
    • Yusuf S, Collins R, Peto R, Furberg C, Stampfer MJ, Goldhaber SZ, Hennekens CH. Intravenous and intracoronary fibronolytic therapy in acute myocardial infarction: overview of results on mortality, reinfarction and side-effects from 33randomized controlled trials. European Heart Journal 1985; 6:556-585.
    • (1985) European Heart Journal , vol.6 , pp. 556-585
    • Yusuf, S.1    Collins, R.2    Peto, R.3    Furberg, C.4    Stampfer, M.J.5    Goldhaber, S.Z.6    Hennekens, C.H.7
  • 16
    • 0023278397 scopus 로고
    • Obtaining medically meaningful answers from an overview of randomized clinical trials
    • Yusuf S. Obtaining medically meaningful answers from an overview of randomized clinical trials. Statistics in Medicine 1987; 6:281-286.
    • (1987) Statistics in Medicine , vol.6 , pp. 281-286
    • Yusuf, S.1
  • 19
    • 84877580161 scopus 로고    scopus 로고
    • Community Cancer Oncology Program:
    • Community Cancer Oncology Program:http://prevention.cancer.gov/programs-resources/programs/ccop.
  • 21
    • 33845978362 scopus 로고    scopus 로고
    • Translational Research: Moving Discovery to Practice
    • Zerhouni EA. Translational Research: Moving Discovery to Practice. Clinical Pharmacology & Therapeutics 2007; 81:126-128.
    • (2007) Clinical Pharmacology & Therapeutics , vol.81 , pp. 126-128
    • Zerhouni, E.A.1
  • 22
    • 0029049462 scopus 로고
    • Epidemiology faces its limits
    • Taubes G. Epidemiology faces its limits. Science 1995; 269:164-169.
    • (1995) Science , vol.269 , pp. 164-169
    • Taubes, G.1
  • 23
    • 0015216518 scopus 로고
    • Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. IV. A preliminary report on phenformin results
    • University Group Diabetes Program.
    • University Group Diabetes Program. Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. IV. A preliminary report on phenformin results. Journal of the American Medical Association 1971; 217:777-784.
    • (1971) Journal of the American Medical Association , vol.217 , pp. 777-784
  • 24
    • 0014952170 scopus 로고
    • The Coronary Drug Project: initial findings leading to modifications of its research protocol
    • Coronary Drug Project Research Group.
    • Coronary Drug Project Research Group. The Coronary Drug Project: initial findings leading to modifications of its research protocol. Journal of the American Medical Association 1970; 214:1303-1313.
    • (1970) Journal of the American Medical Association , vol.214 , pp. 1303-1313
  • 29
    • 0017695033 scopus 로고
    • Monitoring treatment differences in long-term clinical trials
    • Canner PL. Monitoring treatment differences in long-term clinical trials. Biometrics 1977; 33:603-615.
    • (1977) Biometrics , vol.33 , pp. 603-615
    • Canner, P.L.1
  • 31
    • 1842730273 scopus 로고    scopus 로고
    • Increasing the sample size when the unblinded interim result is promising
    • Chen JYH, DeMets DL, Lan KKG. Increasing the sample size when the unblinded interim result is promising. Statistics in Medicine 2004; 23(7):1023-1038.
    • (2004) Statistics in Medicine , vol.23 , Issue.7 , pp. 1023-1038
    • Chen, J.Y.H.1    DeMets, D.L.2    Lan, K.K.G.3
  • 34
    • 77951163222 scopus 로고    scopus 로고
    • Deriving chemosensitivity from cell lines: Forensic bioinformatics and reproducible research in high-throughput biology
    • Baggerly KA, Coombes KR. Deriving chemosensitivity from cell lines: Forensic bioinformatics and reproducible research in high-throughput biology. Annals of Applied Statistics 2009; 3:1309-1334.
    • (2009) Annals of Applied Statistics , vol.3 , pp. 1309-1334
    • Baggerly, K.A.1    Coombes, K.R.2
  • 35
    • 78651401851 scopus 로고    scopus 로고
    • Cancer trial errors revealed
    • Reich ES. Cancer trial errors revealed. Nature 2011; 469:139-140.
    • (2011) Nature , vol.469 , pp. 139-140
    • Reich, E.S.1
  • 36
    • 77950571895 scopus 로고    scopus 로고
    • Gene expression based prognostic signatures in lung cancer, ready for clinical use?
    • Subramanian J, Simon R. Gene expression based prognostic signatures in lung cancer, ready for clinical use? Journal of the National Cancer Institute 2010; 102:464-474.
    • (2010) Journal of the National Cancer Institute , vol.102 , pp. 464-474
    • Subramanian, J.1    Simon, R.2
  • 37
    • 0019976346 scopus 로고
    • Multiple Risk Factor Interventional Trial: Risk factor changes and mortality results
    • Multiple Risk Factor Intervention Trial Research Group.
    • Multiple Risk Factor Intervention Trial Research Group. Multiple Risk Factor Interventional Trial: Risk factor changes and mortality results. Journal of the American Medical Association 1982; 248:1465-1477.
    • (1982) Journal of the American Medical Association , vol.248 , pp. 1465-1477


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.