Are you a digital health innovator? Are you building sensors, wearables, or other digital health tools to be used in clinical trials to capture information about how patients feel, function, or survive?

Join the U.S. Food and Drug Administration, the Yale University and Mayo Clinic CERSI and the Yale School of Medicine Center for Outcomes Research and Evaluation (CORE) for an immersive mini-boot camp March 9, being held virtually and in a condensed format due to the COVID-19 pandemic.

Be empowered to navigate the Digital Health Technology development and evaluation journey from patient needs assessment, to product development and validation tailored to supporting the context of use, to measuring patient outcomes and preferences.

The hands-on training will provide an opportunity for early-stage innovators to become fluent with terminology and aware of regulatory considerations and resources, enabling them to:

• Have more informed interactions with regulators.
• Improve their evidence generation.
• Bring safe and effective medical technologies into the health care system in a timely manner.

The emphasis of this boot camp will be on Digital Health Technologies used to facilitate assessment of patient outcomes in clinical trials, i.e., Clinical Outcome Assessments (COAs). 

NOTE: This bootcamp is targeted to beginner and intermediate learners.

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Participants must apply by Feb. 10, and will be notified by Feb. 12 if they are selected to attend.

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IMPACT Bootcamp

Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes

• Date:  Tuesday, March 9, 2021
• Time: 10:30 am to 3:30 pm Eastern Time (9:30 am to 2:30 pm Central Time)
• Location: Online Course, delivered virtually by FDA staff

This event is brought to you by the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI), the Yale School of Medicine Center for Outcomes Research and Evaluation (CORE), and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery.

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Registration

This is an invitation-only event.  Participants are required to complete an interest form/application and will be notified if they are selected and invited to attend. There is no registration fee.

Requests for invitations will be accepted through Feb. 10, 1 p.m. Eastern Time (Noon Central Time).

Pre-boot camp activities: Selected participants must complete approximately one hour of pre-boot camp activities on their own in advance of the live event.

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Speaker Biographies

All instructors for the Impact Bootcamp hold leadership roles at the U.S. Food and Drug Administration.

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Agenda

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Learning Objectives

• Develop high-level understanding of the regulation of medical devices and use vocabulary used by FDA when communicating about patient outcome measurements and DHTs.
• Describe important considerations for development, validation, and use of DHTs and outcome measurement tools for regulatory purposes.
• Differentiate between PPI and PROs, and describe how PPI can inform on unmet needs and tool development.
• Develop practical expertise applying boot camp concepts to cases relevant as an innovator developing and bringing medical technologies to the market.

Key Words

• Digital Health Technologies (DHTs)
• Clinical Outcome Assessments (COAs)
• Patient-Reported Outcomes (PROs)
• Performance Outcomes (PerfOs)
• Observer-Reported Outcomes (ObsROs)
• Patient Preference Information (PPI)

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Questions?

For more information, please contact Allen Chen, Ph.D., U.S. Food and Drug Administration, or cersi@mayo.edu.

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