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.
CLICK HERE to read more about the MCT Program.
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:
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)
CLICK HERE to view other projects within CTTI’s MCT Program.
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 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|