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DIA 2021 Global Annual Meeting


Mixing Modes of Clinical Outcome Assessments in Response to COVID-19

Session Chair(s)

Bill  Byrom, PhD

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.

Speaker(s)

Paul  O'Donohoe, MS, MSc

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
Alan  Kott, MD

Analytics Approaches to Assessing Ongoing Clinical Endpoint Data Consistency

Alan Kott, MD

  • Clinical Vice President and Practice Lead, Data Analytics
  • Signant Health, Czech Republic
Andrew  Potter, PhD

General Regulatory View and Sensitivity Analyses Topic

Andrew Potter, PhD

  • Mathematical Statistician, OB, OTS, CDER
  • FDA, United States