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Are We Ready for Telemedicine-Powered Clinical Trials?
Session Chair(s)
Karen D. Weiss, MD
Vice President, Global Regulatory Affairs
Janssen Pharmaceutical Companies of Johnson & Johnson, United States
Telemedicine enables remote monitoring and interaction with patients to enhance care provision and treatment decisions. These tools used in routine care have enormous potential in providing ways to enable better monitoring of trial participants, and ease participation and engagement with less reliance on clinic visits. This session explores whether we are adequately primed to effectively use telemedicine. Where challenges exist what needs to be changed about the system or telemedicine approach to enable better usage? We will also consider how best telemedicine is used, or not, in clinical trials with reference to some practical examples. Are we driving to a world in which clinical care is not based on an in-person interaction with a health care provider?
Learning Objective : Describe telemedicine, including the drivers for and barriers to its use in clinical trials and care.
Speaker(s)
Straight From the Horse’s Mouth: Lessons Learned From Legal and Regulatory Challenges of Real Remote Trials
Gerrit Hamre, MA
Duke-Margolis Institute For Health Policy (DMI), United States
Research Director
A Telemedicine Proof of Concept Study Evaluating the Remote Detection of Alzheimer’s Disease and Categorization of Severity
Penny Randall, MD
IQVIA, United States
Vice President and Head, CNS Center of Excellence
Can Mobile Apps Faciltate the Use of Telemedicine
Wayne Amchin
FDA, United States
Senior Consumer Safety Officer, ORO, DRCHEN, OND, CDER