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Wednesday, June 30 • 2:00pm - 3:00pm
#344 SL: Mixing Modes of Clinical Outcome Assessments in Response to COVID-19

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-624-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Bill Byrom, PhD

Speaker

Measurement Equivalence of Clinical Outcome Assessments Collected Across Mixed Modes
Paul O'Donohoe, MS, MSc

Analytics Approaches to Assessing Ongoing Clinical Endpoint Data Consistency
Alan Kott, MD

General Regulatory View and Sensitivity Analyses Topic
Andrew Potter, PhD


Speakers
avatar for Bill Byrom

Bill Byrom

Vice President, Product Intelligence and Positioning; Principal, eCOA Science, Signant Health , United Kingdom
Bill is an eCOA scientist and VP of product intelligence and positioning at Signant Health. He has worked in the Pharmaceutical industry for over 30 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable... Read More →
avatar for Paul O'Donohoe

Paul O'Donohoe

Senior Director, eCOA Product and Science, Medidata Solutions, United States
Paul O’Donohoe is Senior Director, eCOA Product and Science at Medidata Solutions, a clinical software platform provider. He is responsible for providing strategic oversight of the development of Medidata's electronic clinical outcome assessment technologies, and supporting internal... Read More →
avatar for Andrew Potter

Andrew Potter

Mathematical Statistician, OB, OTS, CDER, FDA, United States
Andrew Potter is a mathematical statistician in the Division of Biometrics I at the Center for Drug Evaluation and Research of the US Food and Drug Administration, supporting the review work in the Division of Psychiatry. He also leads digital health technology initiatives in the... Read More →
AK

Alan Kott

Clinical Vice President and Practice Lead, Data Analytics, Signant Health, Czech Republic
Dr. Alan Kott is a Practice Leader for Data Analytics at Signant Health. Having led the development of the Data Analytics Program at Signant he has supervised the design and implementation of this program across a large number of studies across indications. He has also provided training... Read More →

Wednesday June 30, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session
  • Beginner Intermediate
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming COVID-19 - Pandemic,Regulator Thinking
  • Tags Session