Session ID: 
172

Digital Models and Telehealth for Clinical Trials Evidence

1:00pm - 2:00pm Wednesday, March 11
Orlando - Orange County Convention Center
W414D

Description

The cost of clinical trials has continued to grow, resulting in delays in bringing therapeutics to market. Also, the explosion of tech and IOT is revolutionizing care. These same technologies should be applied to research. The Apple Heart Study, an app-based, investigational device exemption study to identify atrial fibrillation using a smartwatch algorithm, enrolled 420,000 adults in less than 9 months. The study demonstrated innovative features, including the fully app-based design for enrollment and patient-reported outcomes, as well as the virtual nature of its design and execution which included telehealth visits. No physical “brick and mortar” visits were performed, which afforded the opportunity to massively scale. The session shares findings and pertinent examples from AHS for enabling virtual, telehealth focused clinical trials at scale and how academic medical centers and technology partners can effectively collaborate to build innovative digital models that promote collaborative research.

Learning Objectives

  • Describe key best operational practices that enable highly scalable virtual clinical trials
  • Identify 3-5 emerging use cases for virtual clinical trials
  • Compare the efficiencies of a virtual-based study design with the traditional physical site approach
  • Recognize the clinical, regulatory, safety, and operational benefits and challenges to conducting virtual clinical trials

Speaker(s)

General Manager, Strategic Solutions & Senior Vice President, Corporate Development,
American Well
Associate Professor of Medicine (Cardiovascular Medicine) & Executive Director, ,
Stanford Medicine

Continuing Education Credits

ABPM
1.00
CAHIMS
1.00
CME
1.00
CNE
1.00
CPHIMS
1.00

Audience

Clinical Engineering Professional
CMIO/CMO
Life Sciences Professional

Level

Intermediate