Overview of clinical trials

Required Reading:

1. Historical overview of RCTs

Optional Reading:

1. UCSF notes on Public Law 110-85

Note/Slide Files: BiostatV10-RCT1.pdf (337 KB)

Study designs: Noninferiority versus superiority trials

Optional Reading:

1. FDA, file 1
2. FDA, file 2
3. Hilton JF, 2010

Note/Slide Files: BiostatV09-RCT2.pdf (152 KB)

Assignment Files: Assignment 1.pdf (99 KB)

Monitoring: Group sequential designs for RCTs

Required Reading:

1. Monitoring of clinical trials
2. Shiffman et al, 2007
3. Anderson et al, 2007

Note/Slide Files: BiostatV10-RCT3l.pdf (190 KB)

Assignment Files: Assignment 2.doc (41 KB)

Bayesian monitoring of RCTs

Required Reading:

1. Berry, 2006

Note/Slide Files: BiostatV10-RCT4.pdf (98 KB)

Tool Files: Bayes3.xls (93 KB)

Bayesian adaptation of RCTs

Required Reading:

1. Barker et al, 2009

Optional Reading:

1. Brown et al, 2009

Note/Slide Files: BiostatV10-RCT5.pdf (146 KB)

Bayesian analysis of RCTs

Required Reading:

1. Brophy & Joseph, 2010
2. FDA Guidance, 2006

Optional Reading:

1. Pennello & Thompson, 2008