Key statistical concepts in cancer research.

In this article, we provide a high-level overview of statistical concepts related to study design and data analysis in oncology research. These concepts are discussed for 2 main types of clinical research: (1) observational studies, which focus on biomarker discovery in order to predict disease risk and prognosis, and (2) prospectively designed, well-controlled clinical trials, which are critical for the development of new cancer treatments. Throughout the article, we emphasize the importance of appropriate design and prospectively determined analysis plans. We also hope to promote effective collaboration between oncology investigators and statisticians who center their research on the development of cancer treatments.