Design Issues in Noninferiority/Equivalence Trials
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Hwang IK. ICH E-10 Guideline: Design Issues in Non-Inferiority/Equivalence Trials. Presented at the DIA 5th Annual Biostatistics Meeting, September 4-5, 1998, Tokyo, Japan.
ICH E-10 Guideline. Choice of Control Groups in Clinical Trials. Step 2 Document, December 23, 1998.
ICH E-9 Guideline. Statistical Principles for Clinical Trials. Step 4 Document, 1998.
Anderson S, Hauck WW. A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Comm Stat A. 1983,12:2663–2692.
Dunnett CW, Gent M. An alternative to the use of two-sided tests in clinical trials. Stat Med. 1996;15:1729–1738.
Garbe E, Röhmel J, Gundert-Remy U. Clinical and statistical issues in therapeutic equivalence trials. Eur J Clin Pharmacol. 1993;45:1–7.
Hauck WW. Equivalence trials: A statistical overview. Presented at the DIA Meeting “Statistical Issues in the Pharmaceutical Industry,” March 9-11, 1997, Hilton Head, SC.
Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. Br Med J. 1996;313:36–39.
Morikawa T, Yoshida M. A useful testing strategy in Phase III trials: Combined test of superiority and test of equivalence. J Biopharm Stat. 1995;5(3):297–306.
Ng TH. Broad-sense equivalence in active control equivalence studies. Presented at the 3rd ICSA Applied Statistics Symposium, Plymouth Meeting, PA, 1993.
Ng TH. A specification of treatment difference in the design of clinical trials with active controls. Drug Inf]. 1993;27:705–719.
Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokin Biopharm. 1987;15:657–680.
Temple R. Clinical trials in seriously ill patients— design considerations. PAACNOTES. 1990; 133–143.
The CONSENSUS Study Group. Effects of Enalapril on mortality in severe congestive heart failure: Results of the cooperative North Scandinavian Enalapril survival study (CONSENSUS). N Engl J Med. 1987;316:1429–1435.
The SOLVD Investigators. Effects of Enalapril on survival in patients with reduced ejection fractions and congestive heart failure. N Engl J Med. 1991;325:293–302.
The Acute Infarction Ramipril Efficacy (AIRE) Study Investigators. Effect of Ramipril on mortality of survivors of acute myocardial infarction with clinical evidence of heart failure. The Lancet. 1993;342: 821–828.
ICH E-5 Guideline. Ethnic Factors in the Acceptability of Foreign Clinical Data. Step 4 Document. 1998.