Guest Editors’ Note

Abstract

“Value to Patients: Benefits, Risks, and Costs” was the theme of the 2017 American Statistical Association Biopharmaceutical Section Regulatory-Industry Statistics Workshop (the Biopharm Workshop). The theme explains why more than 800 medical product statisticians gather at Washington, DC annually for the last 20 some years: We are thrilled to go to work every day because we generate, collect, analyze, and present unbiased and precise information about interventions to inform treatment decisions made by patients and their care providers. We all share the same undisputedly important responsibility to serve patients, regardless of our fields: preclinical or clinical, theoretical or applied, biostatistics or epidemiology, pre-market and post-market approval, interventional or observational studies, drugs/biologics or devices, program evaluations or medical products, animal or clinical (our pets and live stocks can be patients too). “Value” in the theme of the 2017 Biopharm Workshop recognized patients’ key role in choosing the best treatments for their own circumstances by weighing relative importance of benefits, risks, and burdens of treatments. Since 2014, Statistics in Biopharmaceutical Research has dedicated a Special Issue for articles submitted by organizers, presenters, or panelists from any session or short course of the annual Biopharm Workshops. The manuscripts of this Special Issue reflect how the Biopharm Workshop participants’ research interests have evolved to be broader and more multidisciplinary in recent years. It features a balanced mix of traditional statistical topics, such as inference of differences in restricted mean survival times and Bayesian noninferiority study of three-arm trials, and patient-focused topics. For example, a manuscript discusses elicitation of patient preferences by applying Bayesian methods for experimental design of discretechoice experiments. Another manuscript in the issue discusses biosimilar analyses, which can increase access to medical products and thus, reduce various burdens on patients and health care in general. In addition, a manuscript on sequential parallel