The what, why and how of Bayesian clinical trials monitoring.
We discuss the advantages and limitations of group sequential methods for monitoring clinical trials data. We describe a Bayesian approach, based upon the use of sceptical prior distributions, that avoids some of the limitations of group sequential methods. We illustrate its use with data from a trial of levamisole plus 5-Fluorouracil for colorectal cancer.
Biometry Branch, Division of Cancer Prevention and Control, National Institutes of Health, Bethesda, MD 20892.
L S
LS
Freedman
D J
DJ
Spiegelhalter
M K
MK
Parmar
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001499:Bayes Theorem; D015982:Bias; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D015179:Colorectal Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D003627:Data Interpretation, Statistical; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D007978:Levamisole / Q000627:therapeutic use; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D016019:Survival Analysis; D015996:Survival Rate
D007978:Levamisole; D005472:Fluorouracil