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DIA 2021 Global Annual Meeting
Mixing Modes of Clinical Outcome Assessments in Response to COVID-19
Bill Byrom, PhD
- 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.
Measurement Equivalence of Clinical Outcome Assessments Collected Across Mixed Modes
Paul O'Donohoe, MS, MSc
- Senior Director, eCOA Product and Science
- Medidata Solutions, United States
Analytics Approaches to Assessing Ongoing Clinical Endpoint Data Consistency
Alan Kott, MD
- Clinical Vice President and Practice Lead, Data Analytics
- Signant Health, Czech Republic
General Regulatory View and Sensitivity Analyses Topic
Andrew Potter, PhD
- Mathematical Statistician, OB, OTS, CDER
- FDA, United States