Using Mobile Technology to Facilitate Clinical Trials
Mobile technology[1] has been used in a variety of ways, but it has yet to be widely incorporated into clinical trials. Currently, in traditional clinical trials, study staff see participants directly at one or more research sites for screening, enrollment, and follow-up (“site-based trials”). Mobile technologies offer the potential to increase the quality and efficiency of clinical trials 1) by allowing participants to participate remotely for some or all study activities, and 2) by creating opportunities to develop novel endpoints[2].
The Clinical Trials Transformation Initiative is implementing four projects to identify and address the challenges related to planning for and conducting clinical trials that use mobile technology. The four projects focus on the following topics:
The scope of the program includes use of mobile technology in FDA-regulated clinical trials after the time of initial participant consent.
WHAT IS THE ANTICIPATED IMPACT OF CTTI’S WORK ON MCTs?
It is anticipated that the MCT program will promote the use of remote technologies in clinical trials in the most scientifically rigorous and ethical manner. CTTI will determine how mobile technologies can be used to improve clinical trials in areas of remote monitoring/engagement and new novel data collections methods to enhance knowledge of disease trajectory and treatment efficacy.
Potential benefits stemming from MCT program efforts include the following:
Expanded patient recruitment
Improved patient experience
Continuous high quality data acquisition
Reduced costs
Increased efficiency
Fewer losses to follow up
Top Deliverables from the MCT Program*
Recommendations & Tools for Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials (Released June 26, 2017)
*Note: You can a find a complete deliverables list from each of the MCT projects on the project pages.
[1] For purposes of this CTTI program, “mobile technology” encompasses mobile applications, telemedicine, and remote sensor devices.
[2] 1) new endpoints that are not currently used, or 2) existing endpoints that can now be measured in new and possibly better ways using mobile technology.
CTTI would like to thank the Program Committee* members for their contributions to this program:
Patrick Archdeacon - U.S. Food and Drug Administration
Cynthia Hahn - Feinstein Institute for Medical Research
Ellen Kelso - Chesapeake IRB
Matthew Kirchoff - National Institutes of Health
Martin Landray - University of Oxford, CTSU
Craig Lipset - Pfizer Inc
Stephen Mikita - Individual Patient/Caregiver
Kristen Miller - U.S. Food and Drug Administration
Leonard Sacks - U.S. Food and Drug Administration
Lisa Shipley - Merck & Co, Inc
Ken Skodacek - U.S. Food and Drug Administration
Pamela Tenaerts - CTTI
Kaveeta Vasisht U.S. Food and Drug Administration
Program Committee Manager: Annemarie Forrest - CTTI