An investigator's introduction to statistical considerations in clinical trials.

The purpose of this paper is to provide an introduction for investigators to many of the statistical considerations for clinical trials that will aid in their collaborations with statisticians for clinical trial research endeavors and when reading the clinical trials literature. The purpose of this paper is not to turn a physician into a statistician, that takes formal training and education, as well as day in and day out immersion in the statistical design and analysis of clinical trials, hence statistician as a profession. Successful clinical trials, not to be confused with only positive clinical trials, are ones that are well designed to answer the trial question, well conducted, and appropriately reported and published, regardless of the results. Physicians and statisticians each play integral roles in the realm of clinical trials and successful clinical trials are the result of collaborations between physicians and statisticians from the beginning of an idea through the manuscript publication.