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Volumn 279, Issue 3, 1998, Pages 222-225

Run-in periods in randomized trials: Implications for the application of results in clinical practice

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PRACTICE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; HUMAN; MAJOR CLINICAL STUDY; MEDICAL LITERATURE; PATIENT SELECTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SAFETY; SCREENING;

EID: 2642616191     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.279.3.222     Document Type: Article
Times cited : (135)

References (37)
  • 1
    • 0002628092 scopus 로고
    • Statistical aspects of clinical trial design
    • Pocock SJ. Statistical aspects of clinical trial design. Statistician. 1982;31:1-18.
    • (1982) Statistician , vol.31 , pp. 1-18
    • Pocock, S.J.1
  • 2
    • 0017042882 scopus 로고
    • Design and analysis of randomized clinical trials requiring prolonged observation of each patient, part I
    • Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient, part I. Br J Cancer. 1976;34:585-612.
    • (1976) Br J Cancer , vol.34 , pp. 585-612
    • Peto, R.1    Pike, M.C.2    Armitage, P.3
  • 3
    • 0029968685 scopus 로고    scopus 로고
    • From trial outcomes to clinical practice
    • From trial outcomes to clinical practice. Drug Ther Bull. 1996;34:38-40.
    • (1996) Drug Ther Bull , vol.34 , pp. 38-40
  • 5
    • 0021686411 scopus 로고
    • Issues in the design and conduct of clinical trials
    • Hennekens CH. Issues in the design and conduct of clinical trials. J Natl Cancer Inst. 1984;73:1473-1476.
    • (1984) J Natl Cancer Inst. , vol.73 , pp. 1473-1476
    • Hennekens, C.H.1
  • 7
    • 0023147319 scopus 로고
    • Patient compliance and the conduct and interpretation of therapeutic trials
    • Haynes RB, Dantes R. Patient compliance and the conduct and interpretation of therapeutic trials. Control Clin Trials. 1987;8:12-19.
    • (1987) Control Clin Trials , vol.8 , pp. 12-19
    • Haynes, R.B.1    Dantes, R.2
  • 8
    • 0014076761 scopus 로고
    • The determination of sample size in treatment-control comparisons for chronic disease studies in which drop-out or non-adherence is a problem
    • Schork MA, Remington RD. The determination of sample size in treatment-control comparisons for chronic disease studies in which drop-out or non-adherence is a problem. J Chronic Dis. 1967;20:233-239.
    • (1967) J Chronic Dis , vol.20 , pp. 233-239
    • Schork, M.A.1    Remington, R.D.2
  • 10
    • 0026492539 scopus 로고
    • Intention-to-treat analysis
    • Newell DJ. Intention-to-treat analysis. Int J Epidemiol. 1992;21:837-841.
    • (1992) Int J Epidemiol , vol.21 , pp. 837-841
    • Newell, D.J.1
  • 11
    • 0021350001 scopus 로고
    • The Lipid Research Clinics Coronary Primary Prevention Trial results, I: Reduction in incidence of coronary heart disease
    • Lipid Research Clinics Program. The Lipid Research Clinics Coronary Primary Prevention Trial results, I: reduction in incidence of coronary heart disease. JAMA. 1984;251:351-364.
    • (1984) JAMA , vol.251 , pp. 351-364
  • 12
    • 0024406369 scopus 로고
    • Final report on the aspirin component of the ongoing Physicians' Health Study
    • Steering Committee of the Physicians' Health Study Research Group. Final report on the aspirin component of the ongoing Physicians' Health Study. N Engl J Med. 1989;321:129-135.
    • (1989) N Engl J Med , vol.321 , pp. 129-135
  • 13
    • 0024995464 scopus 로고
    • The use of a run-in to enhance compliance
    • Lang JM. The use of a run-in to enhance compliance. Stat Med. 1990;9:87-95.
    • (1990) Stat Med , vol.9 , pp. 87-95
    • Lang, J.M.1
  • 14
    • 0342894667 scopus 로고    scopus 로고
    • Randomised, double-blind, placebo-controlled trial of pindolol in combination with fluoxetine antidepressant treatment
    • Perez V, Gilabert I, Faries D, Alvarez E, Artigas F. Randomised, double-blind, placebo-controlled trial of pindolol in combination with fluoxetine antidepressant treatment. Lancet. 1997;349:1594-1597.
    • (1997) Lancet , vol.349 , pp. 1594-1597
    • Perez, V.1    Gilabert, I.2    Faries, D.3    Alvarez, E.4    Artigas, F.5
  • 15
    • 0024321898 scopus 로고
    • Preliminary report: Effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction
    • The CAST (Cardiac Arrhythmia Suppression Trial) Investigators. Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. N Engl J Med. 1989;321:406-412.
    • (1989) N Engl J Med , vol.321 , pp. 406-412
  • 16
    • 0026756286 scopus 로고
    • A double-blind, placebo-controlled multicenter study of tacrine for Alzheimer's disease
    • Davis KL, Thal LJ, Gamzu ER, et al, and the Tacrine Collaborative Study Group. A double-blind, placebo-controlled multicenter study of tacrine for Alzheimer's disease. N Engl J Med. 1992;327:1253-1259.
    • (1992) N Engl J Med , vol.327 , pp. 1253-1259
    • Davis, K.L.1    Thal, L.J.2    Gamzu, E.R.3
  • 17
    • 0029006613 scopus 로고
    • Effects of carvedilol, a vasodilator-β-blocker, in patients with congestive heart failure due to ischemic heart disease
    • Australia-New Zealand Heart Failure Research Collaborative Group. Effects of carvedilol, a vasodilator-β-blocker, in patients with congestive heart failure due to ischemic heart disease. Circulation. 1995;92:212-218.
    • (1995) Circulation , vol.92 , pp. 212-218
  • 18
    • 0029937949 scopus 로고    scopus 로고
    • The effect of carvedilol on morbidity and mortality in patients with chronic heart failure
    • Packer M, Bristow MR, Cohn JN, et al, for the US Carvedilol Heart Failure Study Group. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. N Engl J Med. 1996;334:1349-1355.
    • (1996) N Engl J Med , vol.334 , pp. 1349-1355
    • Packer, M.1    Bristow, M.R.2    Cohn, J.N.3
  • 19
    • 0025827072 scopus 로고
    • Estimating the effect of the run-in on the power of the Physicians' Health Study
    • Lang JM, Buting JE, Rosner B, Cook N, Hennekens CH. Estimating the effect of the run-in on the power of the Physicians' Health Study. Stat Med. 1991;10:1585-1593.
    • (1991) Stat Med , vol.10 , pp. 1585-1593
    • Lang, J.M.1    Buting, J.E.2    Rosner, B.3    Cook, N.4    Hennekens, C.H.5
  • 20
    • 0023845856 scopus 로고
    • Randomised trial of prophylactic daily aspirin in British male doctors
    • Peto R, Gray R, Collins R, et al. Randomised trial of prophylactic daily aspirin in British male doctors. BMJ. 1988;296:313-316.
    • (1988) BMJ , vol.296 , pp. 313-316
    • Peto, R.1    Gray, R.2    Collins, R.3
  • 22
    • 0027413406 scopus 로고
    • A comprehensive algorithm for determining whether a run-in strategy will be a cost-effective design modification in a randomized clinical trial
    • Schechtman KB, Gordon ME. A comprehensive algorithm for determining whether a run-in strategy will be a cost-effective design modification in a randomized clinical trial. Stat Med. 1993;12:111-128.
    • (1993) Stat Med , vol.12 , pp. 111-128
    • Schechtman, K.B.1    Gordon, M.E.2
  • 23
    • 0025598872 scopus 로고
    • The run-in period in clinical trials: The effect of misclassification on efficiency
    • Brittain E, Wittes J. The run-in period in clinical trials: the effect of misclassification on efficiency. Control Clin Trials. 1990;11:327-338.
    • (1990) Control Clin Trials , vol.11 , pp. 327-338
    • Brittain, E.1    Wittes, J.2
  • 25
    • 0003594381 scopus 로고
    • Pacific Grove, Calif: Wadsworth & Brooks/Cole Advanced Books & Software; section 7.4.2
    • Casella G, Berger RL. Statistical Inference. Pacific Grove, Calif: Wadsworth & Brooks/Cole Advanced Books & Software; 1990:section 7.4.2.
    • (1990) Statistical Inference
    • Casella, G.1    Berger, R.L.2
  • 26
    • 0000280377 scopus 로고
    • Should worsening heart failure early after initiation of beta-blocker therapy for chronic heart failure preclude long-term treatment?
    • Abstract 1881
    • Sackner-Bernstein JD, Krum H, Goldsmith RL, et al. Should worsening heart failure early after initiation of beta-blocker therapy for chronic heart failure preclude long-term treatment? Circulation. 1995;92(suppl I):395. Abstract 1881.
    • (1995) Circulation , vol.92 , Issue.1 SUPPL. , pp. 395
    • Sackner-Bernstein, J.D.1    Krum, H.2    Goldsmith, R.L.3
  • 27
  • 28
    • 0027216221 scopus 로고
    • Withdrawal of digoxin from patients with chronic heart failure treated with angiotensin-converting enzyme inhibitors
    • Packer M, Gheorghiade M, Young JB, et al, for the RADIANCE Study. Withdrawal of digoxin from patients with chronic heart failure treated with angiotensin-converting enzyme inhibitors. N Engl J Med. 1993;329:1-7.
    • (1993) N Engl J Med , vol.329 , pp. 1-7
    • Packer, M.1    Gheorghiade, M.2    Young, J.B.3
  • 29
    • 0031051347 scopus 로고    scopus 로고
    • The effect of digoxin on mortality and morbidity in patients with heart failure
    • The Digitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med. 1997;336:525-533.
    • (1997) N Engl J Med , vol.336 , pp. 525-533
  • 30
    • 0025290010 scopus 로고
    • Clinical trials and epidemiology
    • Senn SJ. Clinical trials and epidemiology. J Clin Epidemiol. 1990;43:628-632.
    • (1990) J Clin Epidemiol , vol.43 , pp. 628-632
    • Senn, S.J.1
  • 31
    • 0019336207 scopus 로고
    • The competing objectives of randomized trials
    • Sackett DL. The competing objectives of randomized trials. N Engl J Med. 1980;303:1059-1060.
    • (1980) N Engl J Med , vol.303 , pp. 1059-1060
    • Sackett, D.L.1
  • 32
    • 0028086561 scopus 로고
    • The relationship between clinical trials and clinical practice: The risks of underestimating its complexity
    • Liberati A. The relationship between clinical trials and clinical practice: the risks of underestimating its complexity. Stat Med. 1994;13:1485-1491.
    • (1994) Stat Med , vol.13 , pp. 1485-1491
    • Liberati, A.1
  • 33
    • 0028047157 scopus 로고
    • Users' guides to the medical literature, II: How to use an article about a therapy or prevention, B: What were the results and will they help me in caring for my patients?
    • Guyatt GH, Sackett DL, Cook DJ, for the Evidence-Based Medicine WorkingGroup. Users' guides to the medical literature, II: how to use an article about a therapy or prevention, B: what were the results and will they help me in caring for my patients? JAMA 1994;271:59-63.
    • (1994) JAMA , vol.271 , pp. 59-63
    • Guyatt, G.H.1    Sackett, D.L.2    Cook, D.J.3
  • 34
    • 0026663647 scopus 로고
    • The once-daily dose regimen of carvedilol: A meta-analysis approach
    • Stienen U. The once-daily dose regimen of carvedilol: a meta-analysis approach. J Cardiovasc Pharmacol. 1992;19(suppl 1):S128-S133.
    • (1992) J Cardiovasc Pharmacol. , vol.19 , Issue.1 SUPPL.
    • Stienen, U.1
  • 35
    • 0028510646 scopus 로고
    • Statistical analysis of cost outcomes in a randomized controlled clinical trial
    • Rutten-van Molken MP, van Doorslaer EK, van Vliet RC. Statistical analysis of cost outcomes in a randomized controlled clinical trial. Health Econ. 1994;3:333-345.
    • (1994) Health Econ , vol.3 , pp. 333-345
    • Rutten-van Molken, M.P.1    Van Doorslaer, E.K.2    Van Vliet, R.C.3
  • 36
    • 0029872417 scopus 로고    scopus 로고
    • Checklist of information for inclusion in reports of clinical trials
    • The Asilomar Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Checklist of information for inclusion in reports of clinical trials. Ann Intern Med. 1996;124:741-743.
    • (1996) Ann Intern Med , vol.124 , pp. 741-743
  • 37
    • 9444255722 scopus 로고    scopus 로고
    • Improving the quality of reporting of randomized controlled trials: The CONSORT statement
    • Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA. 1996;276:637-639.
    • (1996) JAMA , vol.276 , pp. 637-639
    • Begg, C.1    Cho, M.2    Eastwood, S.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.