How to Generate Reliable Clinical Trial Results: An Increasing Challenge in the COVID Era
Wednesday, October 21st at 2:00pm ET (1 Hour Webinar)
Current regulatory guidance requires that sponsors ensure the reliability of data generated by clinical trials. Yet, the concept of reliability is not defined in these guidance documents, nor is it made clear how to determine whether reliability has been achieved. The concepts of accuracy and reliability in other arenas of measurement science have been well-defined – and these concepts can be applied to clinical trials, to drive the reliability of critical processes and measurement activities within the trial. Unfortunately, during the COVID-19 crisis problems in critical processes that can impact study results are more likely- and require even greater attention than before, particularly where study endpoints are subjective.
In this presentation, Dr. Nathaniel Katz, WCG’s Analgesic Solutions Chief Scientific Officer and expert on clinical research methodology and former FDA Advisory Committee chair, will present a systematic approach to evaluating and ensuring reliability of data in clinical trials, including:
- Defining the concepts of accuracy and reliability of clinical trial data
- Determining what drives reliability
- Presenting evidence-based options for ensuring trial data reliability
- Discussing several considerations regarding the relationship between the COVID pandemic and trial reliability, including new threats to clinical data reliability and the need to protect the reliability of subjective endpoints in clinical trials of treatments for COVID-19
- Nathaniel Katz, MD, MS, Chief Science Officer, WCG Analgesic Solutions
- Lindsay McNair, MD, MPH, MSBioethics, Chief Medical Officer, WCG
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