On Sept. 6-8 more than 200 participants from across the country attended the 5th Annual Duke-Industry Statistics Symposium (DISS 2017) “Real World Experience and Randomized Clinical Trials.”
Dr. Mary Klotman, Dean of Duke University School of Medicine, provided welcoming remarks. Representatives from industry, including Dr. Thomas Hastings of PPD and Dr. Sudhakar Rao of Janssen also addressed attendees. Dr. Warren Kibbe, Professor of Duke Department of Biostatistics and Bioinformatics and Chief Data Officer for the Duke Cancer Institute gave the opening keynote address, titled “Real World Evidence, EHR’s and Cancer Surveillance.”
The first day of the Symposium was devoted to six short courses with topics: safety and benefit-risk assessment in pharmaceutical development; model-based dose finding in clinical development; weighting methods for comparative effectiveness research; modern methods in Phase I and II Oncology Trials; Bayesian adaptive designs; and causal treatment effect analysis using SAS/STAT software.
Seventeen parallel sessions were held on the remaining days. The final day included a special presentation by Dr. Robert Califf, who has returned to Duke as Professor of Medicine and is also an advisor for Verily Life Sciences after serving as Commissioner of Food and Drug Administration (FDA). Dr. Califf spoke about Evidence Generation in Real World Studies.
Prizes for best posters were awarded for: “A Modified Promising Zone Sample Size Re-estimation Design with Fixed Critical Value” by Xiaoyu Cai, Yi Tsong, Meiyu Shen of FDA and “A new approach for detecting safety signals in clinical trials” by Xianming Tan from University of North Carolina at Chapel Hill.
