The data monitoring experience in the Cardiac Arrhythmia Suppression Trial: The need to be prepared early

Data Monitoring in Clinical Trials: A Case Studies Approach

Volumn , Issue , 2006, Pages 198-208

  Demets, David L ^a   Friedman, Lawrence M ^b  

^a UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

EID: 36849049765     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1007/0-387-30107-0_18     Document Type: Chapter

References (15)

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2. Ruberman W, Weinblatt E, Goldberg JD, Frank CW, Shapiro S. 1977. Ventricular premature beats and mortality after myocardial infarction. N Engl J Med 297:750-757.
3. Morganroth J, Bigger JT, Jr, Anderson JL. 1990. Treatment of ventricular arrhythmia by United States cardiologists: a survey before the Cardiac Arrhythmia Suppression Trials results were available. Am J Cardiol 65:40-48.
4. Furberg CD. 1983. Effect of antiarrhythmic drugs on mortality after myocardial infarction. Am J Cardiol 52:32C-36C.
5. The Cardiac Arrhythmia Pilot Study (CAPS) Investigators. 1988. Effects of encainide, flecainide, imipramine and moricizine on ventricular arrhythmias during the year after acute myocardial infarction: The CAPS. Am J Cardiol 61:501-509.
6. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators. 1989. Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. N Engl J Med 321:406-412.
7. Lan K K G, Friedman L. 1986. Monitoring boundaries for adverse effects in long-term clinical trials. Control Clin Trials 7:1-7.
8. Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, et al. 1991. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med 324:781-788.
9. Cardiac Arrhythmia Suppression Trial II Investigators. 1992. Effects of the antiarrhythmic agent moricizine on survival after myocardial infarction. N Engl J Med 327:227-233.
10. Friedman LM, Bristow JD, Hallstrom A, Schron E, Proschan M, Verter J, De Mets D, et al. 1993. Data monitoring in the cardiac arrhythmia suppression trial. Online Journal of Current Clinical Trials Doc 79, ISSN 1059-2725, July 31.
11. Lan K K G, De Mets DL. 1983 Discrete sequential boundaries for clinical trials. Biometrika 70:659-663.
12. Pawitan Y, Hallstrom A. 1990. Statistical interim monitoring of the Cardiac Arrhythmia Suppression Trial. Stat Med 9:1081-1090.
13. Fleming TR, De Mets DL. 1993. Monitoring of clinical trials: issues and recommendations. Control Clin Trials 14:183-197.
14. Canner PL: 1977. Monitoring treatment differences in long-term clinical trials. Biometrics 33:603-615.
15. Ellenberg S, Fleming T and De Mets D. 2002. Data Monitoring Committees in Clinical Trials: A Practical Perspective. John Wiley & Sons, Ltd., West Sussex, England.