Designs for efficient clinical trials

R Simon
Oncology (Williston Park, NY) 1989, 3 (7): 43-9; discussion 51-3
This article reviews statistical designs for the conduct of efficient Phase II and Phase III clinical trials. Two stage designs for Phase II trials are tabulated which minimize the number of patients entered when the experimental treatment is inactive or not promising. Randomized Phase II trials for selecting the most promising of several experimental regimens are also described. Phase III designs are presented with simple early stopping rules for dropping experimental regimens. Inappropriate sequential analysis of interim data is a likely cause of many spurious claims of treatment effectiveness. General methods for the valid calculation of confidence limits for differences in treatment effectiveness based on sequentially accumulating data are described. Factorial designs for answering "two questions for the price of one" are also discussed.

Full Text Links

Find Full Text Links for this Article


You are not logged in. Sign Up or Log In to join the discussion.

Trending Papers

Remove bar
Read by QxMD icon Read

Save your favorite articles in one place with a free QxMD account.


Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"