Data monitoring and large apparent treatment effects [1]

Controlled Clinical Trials

Volumn 25, Issue 1, 2004, Pages 67-69

  Korn, Edward L ^a   Freidlin, Boris ^a   George, Stephen L ^b  

^a NATIONAL CANCER INSTITUTE   (United States)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PROTOCOL; DATA ANALYSIS; FOLLOW UP; LETTER; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; STATISTICAL SIGNIFICANCE;

EID: 1242293690     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(03)00109-0     Document Type: Letter

References (5)

1. Wheatley K., Clayton D. Be skeptical about unexpected large apparent treatment effects: the case of an MRC AML12 randomization. Control Clin Trials. 24:2003;66-70.
2. Ellenberg S.S., Fleming T.R., DeMets D.L. Data monitoring committees in clinical trials. 2002;22-23 Wiley, Chichester.
3. Freidlin B., Korn E.L., George S.L. Data monitoring committees and interim monitoring guidelines. Control Clin Trials. 20:1999;395-407.
4. Freidlin B., Korn E.L. A comment on futility monitoring. Control Clin Trials. 23:2002;355-366.
5. U.S. Food and Drug Administration. Guidance for industry, providing clinical evidence of effectiveness for human drugs and biologic products. May 1998.