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Session 3: Adapting Safety Data Collection and Management in Clinical Trials During a Pandemic – Potential Implications and Lessons Learned from COVID-19
Session Chair(s)
Lesley Wise, PhD, MSc
Managing Director
Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom
During the COVID-19 pandemic, hospital and clinic resources and personnel have been stretched, and there has been a need to keep clinical trial subjects away from environments where they may be at greater risk of exposure to COVID-19. This has implications for safety management (eg scheduled visits and lab assessments) and potentially for efficacy reporting (eg for patients who complete the study but cannot attend for outcome measurements). Regulatory authorities have produced guidance on potential safety amendments, but the implications for the clinical trials finalization, reporting and assessment are unclear. This session will hear from an industry representative outlining the challenges the COVID situation brings for clinical trial management and regulatory authority representative outlining the expectations for protocol amendments.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand the need to change clinical trial data collection during public health emergencies
- Understand the need to assess potential long term implications on clinical trial data assessment of changes in clinical trial monitoring/conduct
- Identify options for addressing potential data “gaps” caused by changes to routine data collection
Speaker(s)
Speaker
Lesley Wise, PhD, MSc
Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom
Managing Director
Speaker
John Concato, MD, MPH, MS
FDA, United States
Associate Director for Real-World Evidence Analytics, OMP, CDER
COVID-19 Lessons Learned: Challenges (and Opportunities!) in Data Collection and Assessment
Jeremy Jokinen, PhD, MS
Bristol-Myers Squibb Company, United States
Vice President and Head, Safety Evidence and Sciences
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