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SUMMARY:Special Seminar from the Center for Innovative Study Design: Issues in confirmatory clinical trial design for cancer immunotherapies
DESCRIPTION:With Keaven M. Anderson\, Ph.D.\, Merck Research Laboratories \n11:00AM-12:00PM \nLocation: Medical School Office Building (MSOB) x303 \nAbstract: Several issues have arisen in designing clinical trials for immunotherapies to maximize the chance of success. Progression free survival benefit has not been a great surrogate for an overall survival benefit. Immunotherapy may not provide efficacy early either due to a delay in treatment effect or to a possibly unidentified subgroup where treatment is less effective. Thus\, the trials may evaluate multiple endpoints in multiple populations at multiple points in time during the course of the trial. In addition to this large multiple testing issue\, standard methods assuming proportional hazards are likely inefficient for detecting a treatment benefit. Despite all of these challenges\, many trials have proven very successful. An FDA-initiated effort has considered alternatives to logrank tests. The current status of these efforts will be discussed. \nAbout the Speaker: Dr. Keaven Anderson is a Distinguished Scientist working in Late Development Statistics at Merck Research Laboratories where he has performed in various roles since the end of 2003. Keaven is a fellow of the ASA. His primary research interests are in group sequential design\, particularly for studies with time-to-event endpoints. Multiple testing and non-proportional hazards are current areas of interest. Keaven has developed the gsDesign R package and associated Web interface for group sequential design. His PhD in Mathematical Statistics is from Stanford University. Since graduating\, he has been at the Harvard School of Public Health\, the Framingham Heart Study and Centocor/J&J prior to coming to Merck.
URL:https://cisd.staging1140.pendari.com/event/special-seminar-from-the-center-for-innovative-study-design-issues-in-confirmatory-clinical-trial-design-for-cancer-immunotherapies/
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SUMMARY:The 2nd OncoStat Annual Symposium
DESCRIPTION:Location: University of Chicago \nThe two-day symposium aims to bring oncologists and statisticians together to share new research\, discuss novel ideas\, ask questions and provide solutions for cancer clinical trials. In the era of big data\, precision medicine\, and genomics and immune-based oncology\, it is crucial to provide a platform for interdisciplinary dialogues among clinical and quantitative scientists. The OncoStat Annual Symposium serves as a venue for oncologists and statisticians to communicate their views on trial design and conduct\, drug development\, and translations to patient care. To be discussed includes big data and genomics for oncology clinical trials\, novel dose-finding designs\, drug combinations\, immune oncology clinical trials\, and umbrella/basket oncology trials. An important aspect of OncoStat is the participation of researchers across academia\, industry\, and regulatory agency. \nThis annual symposium was started from Stanford last year (http://med.stanford.edu/cisd/events/symposium-May2017.html) and is rotated to U Chicago this year. The event website is at  http://health.bsd.uchicago.edu/yji/oncostat/. Registration from Stanford participants is at a discount rate of $50 for the two day event.
URL:https://cisd.staging1140.pendari.com/event/the-2nd-oncostat-annual-symposium/
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