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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)
Measurement Equivalence of Clinical Outcome Assessments Collected Across Mixed Modes
Paul O'Donohoe, MS, MSc
Medidata Solutions, United States
Senior Director, eCOA Product and Science
Analytics Approaches to Assessing Ongoing Clinical Endpoint Data Consistency
Alan Kott, MD
Signant Health, Czech Republic
Clinical Vice President and Practice Lead, Data Analytics
General Regulatory View and Sensitivity Analyses Topic
Andrew Potter, PhD
FDA, United States
Mathematical Statistician, OB, OTS, CDER
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