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Special Issue of Journal of Biopharmaceutical Statistics dedicated to 2016 Trends and Innovations in Clinical Trial Statistics (TICTS) Conference

Should the Food and Drug Administration (FDA) approve a new weight loss drug if Pr (weight loss of 5kg) > 0.95 instead of using the usual two-sided p-value < 0.05 paradigm? This was just one of the intriguing questions from the 2nd Trends and Innovations in Clinical Trial Statistics (TICTS) conference held in May of 2016 in Durham, North Carolina. Among the highlights were the keynote address on the need of efficient evidence generation system to inform decisions by Robert Califf, the inspirational talk on generating real-world evidence by David Madigan, Steve Ruberg’s talk on making what is novel today routine tomorrow, and thoughts on how to raise the new generation of statisticians by Lisa LaVange. Presenters and panelists discussed a broad range of topics including statistical challenges and opportunities for innovation, novel trial designs and their implementation, Bayesian methods and applications, quantitative evaluation of safety, big data and analytics, clinical trial optimization and visualization, use of modeling and simulations to improve decision making, and clinical trials in small population. This special issue is dedicated to the 2nd TICTS conference, which was co-organized by Quintiles, the Department of Statistics at North Carolina State University, and the North Carolina Chapter of the American Statistical Association. The issue includes articles on missing data, multiple comparisons, sample size re-estimation, Bayesian methods and applications, strategies for estimating a homogeneous treatment effect in observational studies, use of modeling and simulations to improve decision making, and methods in oncology. Oncology is well represented with papers covering methods for phase 1 dose-finding studies up to phase 2/phase 3 program optimization. Some articles are based on the actual talks presented at the conference and some are based on the topics covered at the conference but not necessarily presented. We thank the authors of the original articles for their contributions to this special issue. We believe these contributions, taken together, will provide readers with new insights and perspectives on current trends and innovations in clinical trial statistics. Additionally, we are grateful to the Journal’s Editor-in-Chief, Prof. Shein-Chung Chow, for the opportunity to organize this special issue and Ms. Victoria Chang for her extensive editorial assistance.