Using Mobile Technology to Facilitate Clinical Trials
Mobile technology 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.
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
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)