Program: Mobile Clinical Trials (MCT)

About This Program

Project:

Use of Mobile Devices

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Scientific and Technological Issues Surrounding the Use of Mobile Devices in Clinical Trials

Although many successful pilot studies utilizing mobile devices have been completed, mobile devices are not yet widely used in clinical trials for submission purposes. Particular scientific and technological issues associated with the use of mobile devices inhibit their widespread adoption into clinical trials. Such issues include, but are not limited to, data challenges (e.g., data origins and integrity) and device challenges (e.g., user authentication/access control).

The goal of this project within CTTI’s MCT Program is to propose recommendations that address the scientific and technological challenges inhibiting the widespread use of mobile devices in clinical trials. The scope of the program includes use of mobile technology in FDA-regulated clinical trials after the time of initial participant consent.

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Under development

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One reason why mobile technology is not yet widely used in clinical trials may be the scientific and technological issues associated with the use of mobile devices, including the data and device challenges listed below:

Data Challenges:

  • Origins
  • Integrity
  • Transmission
  • Analysis
  • Security
  • Backup
  • Archiving
  • Submission

Device Challenges:

  • User authentication/access control
  • Management of the physical device
  • Bring your own device (BYOD)
  • Device failure
  • Device reuse
  • Performance considerations

Until these issues are addressed, the benefits of using mobile technology to facilitate clinical trials cannot be realized.

Mobile Clinical Trials Program: Scientific and Technological Issues Surrounding the Use of Mobile Devices in Clinical Trials (2015 – ongoing)

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  • Identify solutions to the data challenges associated with using mobile devices in clinical trials.
  • Identify and describe the scientific and technical considerations associated with managing mobile devices for use in clinical trials and develop guiding principles to promote their inclusion.

The results from the MCT Mobile Devices Project will inform how to address the scientific and technical challenges related to the use of mobile devices in clinical trials.

Standard CTTI evidence-gathering methodology will be employed for this program, which includes gap analysis, comprehensive reviews and/or interviews, and expert/multi-stakeholder meetings.

Specific methods are currently being defined for each project within the program. Watch this space for new developments.

Project Team Members

Rolesort descending Name Affiliation
Project Manager Jen Goldsack CTTI
Team Lead Marisa Bolognese The Life Raft Group
Team Lead Phil Coran Medidata Solutions
Team Lead Cheryl Grandinetti U.S. Food and Drug Administration
Team Lead Seleen Ong Pfizer Inc
Team Lead Kaveeta Vasisht Food and Drug Administration
Team Member Chris Miller AstraZeneca Pharmaceuticals LP
Team Member Ashish Narayan Feinstein Institute for Medical Research
Team Member Dharmesh Patel U.S. Food and Drug Administration
Team Member Jane Shen PMG Research, Inc
Team Member Tom Switzer Genentech - A Member of the Roche Group
Team Member Evan Wearne U.S. Food and Drug Administration
Team Member Molly Flannery U.S. Food and Drug Administration
Team Member Adam Amdur Sleep Apnea Association
Team Member Aiden Doherty University of Oxford
Team Member Jonathan Helfgott Stage 2 Innovations
Team Member Matthew Kirchoff National Institutes of Health
Team Member Phil Kronstein U.S. Food and Drug Administration