Type I error in sample size re-estimations based on observed treatment difference

Statistics in Medicine

Volumn 20, Issue 4, 2001, Pages 497-513

  Shun, Zhenming ^a,b   Yuan, William ^a   Brady, William E ^a   Hsu, Huang ^a  

^a BRISTOL MYERS SQUIBB   (United States)

^b NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; ANALYTICAL ERROR; ARTICLE; CALCULATION; CLINICAL TRIAL; COMPUTER SIMULATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DECISION MAKING; MATHEMATICAL ANALYSIS; SAMPLE;

CLINICAL TRIALS; DRUG APPROVAL; HUMANS; SAMPLE SIZE; STATISTICS;

EID: 0035961515     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.531     Document Type: Article

References (9)

1. Designed extension of studies based on conditional power
2. Modification of sample size in group sequential clinical trials
3. The use of interim analysis for sample size adjustment
4. Estimation of parameters and sample size re-estimation
5. A regulatory perspective on data monitoring and interim analysis
6. Interim analyses: An FDA reviewer's experience and perspective
7. Discrete sequential boundaries for clinical trials
8. Interim analyses for monitoring clinical trials that do not materially affect the type I error rate
9. Sample size reestimation without unblinding for normally distributed outcomes with unknown variance