Guidelines for the design of clinical trials with longitudinal outcomes

Controlled Clinical Trials

Volumn 23, Issue 3, 2002, Pages 257-273

  Galbraith, Sally ^a,b   M Stat, ^a,b   Marschner, Ian C ^a,b  

^a UNIVERSITY OF SYDNEY   (Australia)

^b PFIZER INC   (United States)

Author keywords

Clinical trials design; Dropout; Longitudinal outcomes; Power; Random effects models; Rates of change; Sample size

Indexed keywords

CLINICAL TRIAL; COST; MEASUREMENT; METHODOLOGY; MODEL; PRACTICE GUIDELINE; REVIEW; SAMPLE SIZE;

EID: 0036275456     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(02)00205-2     Document Type: Article

References (15)

1. Sample size estimation using repeated measurements on biomarkers as outcomes
2. Repeated measures in clinical trials: Analysis using mean summary statistics and its implications for design
3. Linearly divergent treatment effects in clinical trials with repeated measures: Efficient analysis using summary statistics
4. Planning group sizes in clinical trials with a continuous outcome and repeated measures
5. Sample size calculations for studies with correlated observations
6. Sample size for comparison of changes in the presence of right censoring caused by death, withdrawal and staggered entry
7. The effect of drop-out on the efficiency of longitudinal experiments
8. Sample size requirements and the cost of a randomized clinical trial with repeated measurements
9. Intentionally incomplete longitudinal designs: I. Methodology and comparison of some full span designs
10. Estimation and comparison of rates of change in longitudinal studies with informative drop-outs
11. Estimation and comparison of changes in the presence of informative right censoring by modeling the censoring process
12. Adjusting for dropout in clinical trials with repeated measures: Design and analysis issues
13. Handling missing data in clinical trials: An overview