Statistical Methods for Comparison to Placebo in Active-Control Trials

Vic Hasselblad1, David F. Kong1
11 Duke Clinical Research Institute , Durham, North Carolina.

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Tài liệu tham khảo

Hasselblad, V. Meta-analysis of multi-treatment studies. Med Decis Making. 1998;18:37–43.

CAPRI E Steering Committee. A randomized, blinded, trial of Clopidogrel versus aspirin in patients at risk of ischemic events (CAPRIE). Lancet. 1996;348:1329–1339.

Antiplatelet Trialists’ Collaboration. Collaborative overview of randomized trials of antiplatelet therapy-I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. Br Med, J. 1994;308:81–106.

Eddy, DM, Hasselblad, V, Shachter, RD. In: The Statistical Synthesis of Evidence: Meta-analysis By the Confidence Profile Method. Boston, MA: Academic Press; 1992.

Fisher, LD. Active control trials: What about a placebo? A method illustrated with Clopidogrel, aspirin and placebo. 7 Am Coll Cardiol. 1998;31:49A.

Bucher, HC, Guyatt, GH, Griffith, LE, et al. The results of direct and indirect treatment comparisons in metaanalysis of randomized controlled trials. J Clin Epidemiol. 1997;50:683–691.

Hauck, WW, Anderson, S. Some issues in the design and analysis of equivalence trials. Drug Inf, J. 1999;33: 109–118.

Simon, R. Bayesian design and analysis of active control clinical trials. Biometrics. 1999;55:18–21.

Fleming, TR. Evaluation of active control trials in AIDS. J Acquired Immune Deficiency Syndromes. 1990; 3(Supp 2):S82–S87.

Hasselblad, V, Mosteller, F, Littenberg, B, et al. A survey of current problems in meta-analysis: Discussion from the AHCPR inter-PORT Work Group on Meta-Analysis. Med Care. 1995;33:202–220.

Kendall, MG, Stuart, A. In: The Advanced Theory of Statistics. Vol. 1. New York, NY: Hafner Publishing, Co.; 1961.

The PURSUIT Trial Investigators. Inhibition of platelet glycoprotein Iib/IIIa with eptifibatide in patients with acute coronary syndromes. New Engl J Med. 1998;339:436–443.

Alexander, JH, Al-Khatib, S, Canter, W. Highlights from the American College of Cardiology 48th Annual Scientific Sessions: March 7 to 10, 1999. Am Heart, J. 1999;138:183.

The GUSTO Trial Investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med. 1993;329:673–682.

The GISSI-I Trial Investigators. Long-term effects of intravenous thrombolysis in acute myocardial infarction: Final report of the GISSI study. Lancet. 1987; October 17:871–874.

The ISIS-2 Trial Investigators. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. Lancet. 1988; August 13:349–360.

Califf, RM. A perspective on the regulation of the evaluation of new antithrombotic drugs. Am J Cardiol. 1998; 82:25–35.

Koch, GG, Amara, IA. Statistical issues in the design and analysis of ulcer healing and recurrence studies. Drug Inf, J. 1993;27:805–824.

D’Agostino, RB, Heeren, TC. Multiple comparison in over-the-counter drug clinical trials with both positive and placebo controls. Stat Med. 1991;10:1–6.

Dunnett, CW, Tamhane, AC. Comparisons between a new drug and active and placebo controls in an efficacy clinical trial. Stat Med. 1992;11:1057–1063.