ABSTRACT
The focus of this chapter is on issues pertaining to cancer prevention trials. In particular, interest is in large randomized controlled trials with cancer occurrence as the primary endpoint, as these are considered to exhibit rigorous study design [1,2]. It is recognized that many issues discussed here are relevant to a wider group of trials. Additional information regarding such trials can be found in other sources [1,3-10]. Following is a description of relevant considerations in the design, summarization,
analysis, and interpretation of cancer prevention trials. Specific aspects of these considerations are illustrated using the reduction by dutasteride of prostate cancer events (REDUCE) prostate cancer (PCa) risk reduction study [11] as an example.
