Expert Meeting

Legal & Regulatory Issues Affecting the Adoption of Mobile Clinical Trials

CTTI Project: Decentralized Clinical Trials

Meeting Location

Sheraton Silver Spring Hotel 8777 Georgia Ave, Silver Spring, MD

 

CLICK HERE for the meeting summary.
CLICK HERE for the meeting agenda.
CLICK HERE for a list of the meeting attendees.

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 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

*The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.