DIA 2021 Global Annual Meeting

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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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