Clinical Trials & Human Factors Studies during a Pandemic
A Virtual Event
December 07, 2020

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:

·      Clinical

·      Human factors specialists

·      Instructional learning experts

·      Regulatory

·      Quality


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


Monday, December 7
12:00 PM - 1:30 PM
12:00 PM - 1:30 PM
Sr. Human Factors Consultant
Agilis Consulting Group
Executive Director, CPC Clinical Research; Cardiologist & Vascular Medicine Specialist
Associate Director, Research & Community Health Operations
CPC Clinical Research
Sr. Human Factors Consultant
Agilis Consulting

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What are the registration prices:

Medical Technology Organization:

  • Early bird registration is $95 - Available until Nov. 12, 2020
  • Regular Registration is $125 - Available between Nov 13- Nov. 30, 2020
  • Late Registration is $150 - After Nov. 30, 2020

Group Registrations:

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. 

How do I log in to the event?

  • A log in link to GoToWebinar will be included in your Registration Confirmation Email. You MUST Register with GoToWebinar in order to join the event on the day of. Also please note that this will be a live event.

Can I ask questions of the speakers?

  • Yes! You will be able to type your questions into a chat dialog box and the moderator will read it out loud to the speakers.

What happens if I miss the event:

  • There are no refunds or cancellations within 7 business days of the starting date of the event.

Cancellation and Refund Policy:

  • All cancellations must be made via email. Should you not be able to attend the virtual event, you may have someone else from your organization take your place or use your registration fee as credit towards a future MedTech event. If these options are not possible, you can receive a refund of the registration fee less a 20% processing fee up until 7 business days prior to the virtual event. There are no refunds for cancellations within the 7 day period prior to the virtual event or for "no-shows" to the virtual event.