Clinical Trials & Human Factors Studies during a Pandemic
The COVID-19 pandemic has required a new approach to clinical trials and human factors studies. Normally these studies require considerable face-to-face interaction, which has been difficult during the pandemic. Those designing and conducting studies have been forced to develop new methods and protocols that safeguard subjects and coordinators without sacrificing study integrity and validity. Some of these approaches created by necessity suggest procedures that can be used post-pandemic to conduct more efficient and cost-effective studies.
· Clinical trials
o The challenges of clinical trials during the pandemic
o FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Public Health Emergency
o Strategies and procedures for clinical trial conduct
o Questions and concerns by manufacturers, sites, and IRBs
o Case study
· Human factors studies
o Unique challenges of human factors studies during the pandemic
o Considerations and strategies for remote or in-person HF studies
o Issues that continue to pose challenges
o Case Study
· Q&A on clinical trials and human factors studies
· Lessons learned that can streamline or enhance procedures post-pandemic
· Q&A on changes in future studies.
· Deb Billings, PhD is a Senior Human Factors Consultant at Agilis,
· Sophia Kalita – Senior Human Factors Consultant at Agilis Consulting
· Marc Bonaca, MD, MPH, FAHA, FACC – Executive Director, CPC Clinical Research, & Professor of Medicine, Cardiology, & Vascular Medicine, Director of Vascular Research, University of Colorado
· Nicole Jaeger – Associate Director, Research & Community Health Operations, CPC Clinical Research
Who should attend:
· Human factors specialists
· Instructional learning experts
What you will learn:
· Study challenges during a pandemic
· FDA guidance on clinical studies during COVID-19
· Strategies and procedures for clinical trials during a pandemic
· Strategies and procedures for human factors studies during a pandemic
· Long-term opportunities for more efficient clinical and human factors research based on lessons from COVID-19
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Medical Technology Organization:
If you register a group of more than 2 registrations at the same time, each registration after the 1st receives a 50% discount. Remember, in order to receive this discount, registrations MUST BE MADE AT THE SAME TIME. There will be no retroactive refunds of registration fees.
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