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Mixing Modes of Clinical Outcome Assessments in Response to COVID-19
Session Chair(s)
Bill Byrom, PHD
Vice President, Product Intelligence and Positioning; Principal, eCOA Science, Signant Health , United Kingdom
The COVID-19 pandemic has led us to change the way that site-based assessments have been conducted. This session explores the impact of mixing modes, the use of analytics methods to assess data consistency and how/when to use sensitivity analyses.
Learning Objective : Describe the data integrity considerations associated with mixing modes, and review current evidence on the impact of mixing modes; Identify the value of analytics methods to assess data consistency resulting in mixing modes of data collection; Discuss how and when to use formal sensitivity analyses in studies where mixing modes was implemented as a result of COVID-19.
Speaker(s)
Paul O'Donohoe, MS, MSC
Senior Director, eCOA Product and Science, Medidata Solutions, United States
Measurement Equivalence of Clinical Outcome Assessments Collected Across Mixed Modes
Alan Kott, MD
Clinical Vice President and Practice Lead, Data Analytics, Signant Health, Czech Republic
Analytics Approaches to Assessing Ongoing Clinical Endpoint Data Consistency
Andrew Potter, PHD
Associate Director, Biostatics, United States
General Regulatory View and Sensitivity Analyses Topic
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