TL39: Crossover Design in Clinical Studies
*Steven Bai, U.S. Food and Drug Administration *Tao Wang, Eli Lilly and Company Keywords: crossover design, clinical trial, carryover effect, switch treatments, washout period, baseline selection For decades, crossover design has been widely applied to pharmaceutical studies, such as PK/PD, bioequivalence, medical device (preference and safety endpoints), and all-phase clinical trials. However, in spite of the unique benefits crossover studies can bring to patients (e.g. evaluate safety/efficacy when patients switch treatments); discussions about its applicability and interpretability are still an on-going effort among academia, industry, and regulators, especially for late-phase clinical trials. We will take this opportunity to discuss key topics including suitable disease states and patient populations, carryover effect, washout period, baseline selection, proper/novel analysis methods, benefit/risk evaluation, and the design's future in clinical studies to help patients. Any other relevant topics are welcome to be brought to the table as well.
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC