An overview of competing risks data, with applications in clinical trials

This talk will survey competing risks, with an eye towards clinical trials applications. Conceptual issues related to endpoint definition will be explored, following by a discussion of standard analytic methods, including one sample estimation, two sample testing, and regression modelling. Issues related to summarizing treatment differences will be examined, including challenges in extending standard approaches for independently censored data to the competing risks setting. A primary focus will be a comparison of analyses based on the cause specific hazard and on the cumulative incidence functions. The current state of competing risks methodology in clinical trials will be reviewed, with potential areas for further development highlighted, particularly in the area of adaptive designs. Real data examples will illustrate the main points.