Missing data is a reality in clinical trials, and the practical complexities associated with analysis of missing data need attention. A case study comprising a recently completed Phase III randomized, double-blinded, placebo-controlled trial will be used to motivate the discussion. Scientific rationale for the trial, the a priori assumptions used at the design stage, issues encountered due to unplanned proportions of missing data that led to revisions of the study design and endpoints, and the involvement of the regulatory and oversight committees will be the background for this discussion. This session is intended to identify possible and practical ways to handle analyses of such data.