Tempe, AZ, January 23, 2020 – Dale W. Usner, PhD, Chief Scientific Officer & Sr. Vice President, Strategic Scientific Consulting at SDC, will present “Considerations and Impact of Various Hypothetical Strategies for Handling Intercurrent Events” at the Duke-Industry Statistics Symposium (DISS) on Thursday, April 2, 2020.
Hosted by the Department of Biostatistics and Bioinformatics at Duke University School of Medicine, the annual symposium promotes research and collaboration among statisticians from industry, academia and regulatory agencies. Concluding with a job fair on Friday afternoon, the three-day event will focus on “Emerging Clinical Initiatives in Pharmaceutical Development: Methodology and Regulatory Perspectives.”
Usner’s presentation will be held during the Thursday afternoon session on ICH E9 (R1)-Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials. Co-organized by Roann Seay, Senior Biostatistician at SDC, this session features five presenters to explain the ICH E9 (R1) addendum and provide important guidance for understanding and implementing estimands in clinical trials.
“Estimands and intercurrent events have been an interest of mine since the ICH E9 (R1) draft was first released a couple years ago,” said Usner. “I am particularly interested in the impact of differential handling of intercurrent events on the outcomes of primary and sensitivity/robustness analyses. I look forward to discussing these in detail at the symposium.”
“On behalf of the organizing committee, we are very grateful for Dale to share his expertise in the area of estimands and sensitivity analyses at the symposium,” said Seay. “With statistical leaders from CROs, sponsors, regulatory bodies and academia addressing key topics like ICH E9 (R1), data monitoring committees, adaptive trial designs and artificial intelligence, DISS is shaping up to be a must-attend event this year.”
For more information or to register for DISS 2020, please visit https://sites.duke.edu/diss.