A unified theory for sequential clinical trials

J Whitehead
Statistics in Medicine 1999 September 15, 18 (17): 2271-86
The theory underlying sequential clinical trials is now well developed, and the methodology is increasingly being implemented in practice, both by the pharmaceutical industry and in the public sector. The consequences of conducting interim analyses for frequentist interpretations of data are now well understood. A large number of approaches are available for the calculation of stopping boundaries and for the eventual terminal analysis. In this paper, the principles of the design and analysis of sequential clinical trials will be presented. Existing methods will be reviewed, and their relationships with the general principles will be clarified. Controversies and gaps within the methodology will be highlighted. It is intended that presentation of the subject as a single unified theory will allow the few essential underlying features to be better appreciated.

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"