Experience collecting interim data on mortality: An example from the RALES study

Current Controlled Trials in Cardiovascular Medicine

Volumn 2, Issue 1, 2001, Pages 59-62

  Wittes, Janet ^a   Palensky, Jolie ^a   Asner, Debra ^b   Julian, Desmond ^c   Boissel, Jean Pierre ^d   Furberg, Curt D ^e   Kulbertus, Henri ^f   Pocock, Stuart ^g   Roniker, Barbara ^b  

^a University of Iowa   (United States)

^b PFIZER INC   (United States)

^c Hospital Neuro Cardiologique ^*

^d HÔPITAL NEUROLOGIQUE   (France)

^e WAKE FOREST SCHOOL OF MEDICINE   (United States)

^f UNIVERSITY OF LIÈGE   (Belgium)

^g LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

Author keywords

Data safety monitoring boards; Data sweeps; Interim analysis; Randomized clinical trials

Indexed keywords

PLACEBO; SPIRONOLACTONE;

ARTICLE; CLINICAL PROTOCOL; CLINICAL STUDY; CLINICAL TRIAL; COMPUTER SIMULATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DATA ANALYSIS; DEATH; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG MONITORING; FOLLOW UP; HUMAN; INFORMATION PROCESSING; MAJOR CLINICAL STUDY; MORTALITY; RANDOMIZED CONTROLLED TRIAL; STATISTICAL ANALYSIS;

EID: 0035099250     PISSN: 14686708     EISSN: None     Source Type: Journal    
DOI: 10.1186/CVM-2-1-059     Document Type: Article

References (6)

1. Data safety monitoring boards: A brief introduction
2. Clinical trials and treatment effects monitoring
3. Toward vital status sweeps: A case history in sequential monitoring
4. The effect of spironolactone on morbidity and mortality in patients with severe heart failure
5. Discrete sequential boundaries for clinical trials
6. A multiple testing procedure for clinical trials