Design and interpretation of equivalence trials

American Heart Journal

Volumn 139, Issue 4, 2000, Pages

  Fleming, Thomas R ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARDIOVASCULAR SYSTEM; CLINICAL RESEARCH; CLINICAL TRIAL; CONFERENCE PAPER; CORONARY ARTERY; HUMAN; OUTCOMES RESEARCH; PRIORITY JOURNAL; SAMPLE; STATISTICS;

EID: 0034038181     PISSN: 00028703     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0002-8703(00)90067-X     Document Type: Conference Paper

References (12)

1. 1. GUSTO Investigators. A comparison of reteplase with alteplase For acute myocardial infarction. N Engl J Med 1997;337:1118-23.
2. 2. White HD. Thrombolytic therapy and equivalence trials. J Am Coll Cardiol 1998;31:494-6.
3. 3. Lang TA, Secic M. Differences between clinical and statistical significance. In: Lang TA, Secic M. How to report statistics in medicine: annotated guidelines for authors, editors, and reviewers. ACP Series Medical Writing and Communication. Philadelphia: American College of Physicians; 1997. p. 23-5.
4. 4. Borenstein M. The case for confidence intervals in controlled clinical trials. Control Clin Trials 1994;15:411-28.
5. 5. Jolley D. The glitter of the t table. Lancet 1993;342:27-9.
6. 6. Bailor JC, Mosteller F. Guidelines for statistical reporting in articles for medical journals. Ann Intern Med 1988;108:266-73.
7. 7. Bode C, Smalling RW, Berg G, et al. Randomized comparison of coronary thrombolysis achieved with double-bolus reteplase (recombinant plasminogen activator) and front-loaded, accelerated alteplase (recombinant tissue plasminogen activator) in patients with acute myocardial infarction. Circulation 1996;94:891-8.
8. 8. Smalling RW, Bode C, Kalbfleisch J, et al. More rapid, complete, and stable coronary thrombolysis with bolus administration of reteplase compared with alteplase infusion in acute myocardial infarction. Circulation 1995;91:2725-32.
9. 9. Continuous Infusion versus Double-Bolus Administration of Alteplase (COBALT) Investigators. A comparison of continuous infusion of alteplase with double-bolus administration for acute myocardial infarction. N Engl J Med 1997:337:1124-30.
10. 10. Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med 1996;125:605-13.
11. 11. Berman E, Heller G, Santorsa J, et al. Results of a randomized trial comparing idarubicin and cytosine arabinoside with daunorubicin and cytosine arabinoside in adult patients with newly diagnosed acute myelogenous leukemia. Blood 1991;77:1666-74.
12. 12. Vogler WR, Velez-Garcia E, Weiner RS, et al. A phase III trial comparing idarubicin and daunorubicin in combination with cytarabine in acute myelogenous leukemia: a Southeastern Cancer Study Group study. J Clin Oncol 1992; 10:1103-11.