Meeting Objectives

• Present findings from evidence gathering activities
• Discuss how this evidence may be used to provide direction for the appropriate utilization of mobile technology in clinical trials
• Describe what products CTTI should develop to equip change agents to overcome the legal and regulatory barriers that inhibit more widespread use of mobile technology in clinical trials, including for the purposes of regulatory submission

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

1. Introduction to the Clinical Trials Transformation Initiative by Annemarie Forrest
2. Offsite Trials by Leonard Sacks
3. Issue, Project Overview, and Meeting Objectives by Gerrit Hamre
4. Qualitative Sponsor Interview Findings by David Babaian
5. On the Ground and In the Cloud: Lessons Learned from Operating DCTs by Laura Podolsky
6. Combining Crowdsourced Protocol Design and Digital Study Execution by Marc Foster
7. Advancing Patient-Centered Clinical Trials by Implementing At-home Study Visits by Gail Adinamis
8. Conducting Trials Remotely via Telehealth by Michael O’Brien
9. Telehealth Public Policy Trends and Issues by Mario Gutierrez
10. Telemedicine: Expanding Access, Protecting Patients by Lisa Robin
11. Navigating State Telemedicine Laws by Ross Friedberg