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Proceedings of the University of Pennsylvania 11th annual conference on statistical issues in clinical trials: Estimands, missing data and sensitivity analysis

This issue of Clinical Trials contains the proceedings of the 11th annual Conference on Statistical Issues in Clinical Trials, held at the University of Pennsylvania in April 2018. This symposium addressed ongoing and emerging issues related to estimands, missing data and sensitivity analysis in Clinical Trials. The Food and Drug Administration (FDA) and other international regulatory authorities have recently issued a revision of the guidance entitled ‘‘Statistical Issues in Clinical Trials,’’ that focuses on these issues, so this is an extremely timely topic. This one-day conference included speakers who were involved in developing this revision, as well as statisticians with substantial expertise in the methods for handling missing data and performing sensitivity analyses. Many other topics arose throughout the panel and general discussions. As in prior conferences, panel discussants and members of the audience offered additional interesting perspectives on the issues. In this issue, you will find papers presented at the conference as well as edited transcripts of the panel and general discussions (Table 1). The Penn series of one-day conferences on statistical issues in clinical trials is intended to provide intense focus on an area of statistical methodology of continued and/or emerging interest related to the design, conduct and analysis of clinical trials. Topics have ranged from ‘‘proof of concept’’ trials to comparative effectiveness studies. All conference proceedings except the first have been published in Clinical Trials.