TL15: Statistical Design and Analysis Challenges for Monitoring Devices
*Shanti V Gomatam, FDA/CDRH/DBS Keywords: Monitoring devices can be defined as devices that are used to repeatedly examine patient condition to assess potential changes in status (that may dictate changes in treatment). These repeated measurements can be either qualitative or quantitative. Types of devices include continuous monitors (for eg. blood glucose monitors, continuous blood pressure monitors, fetal monitors), event monitors (cardiovascular event monitors, seizure detection monitors etc.), and intermittent patient status monitors (tumor monitoring assays, mammograms etc.) Statistical design and analysis challenges for such devices will be the topic of discussion at this roundtable.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC