Program: Mobile Clinical Trials (MCT)

Program:

Mobile Clinical Trials (MCT)

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:

  1. Decentralized Clinical Trials
  2. Novel Endpoints
  3. Stakeholder Perceptions 
  4. Mobile Technologies 

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*

*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

*The Program Committee is no longer active.