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 regulatory 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 develop recommendations and tools 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 devices (mobile applications and remote sensor devices that capture objective data, including both consumer and medical grade devices) in FDA-regulated clinical trials after the time of initial participant consent.
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.
Clinical trials will use mobile devices to collect objective data, which will improve the quality and efficiency of medical product development.
Interviews were conducted in two phases. First, we solicited input from research sponsors and clinical investigators experienced in using mobile devices in clinical trials. These preliminary results revealed challenges related to data management, validation, analysis, and security. Sponsors and investigators shared their approach to mobile device selection as well as to managing and reporting safety signals and adverse events. The preliminary results were shared in a webinar. A second phase of interviews with technical experts (device manufacturers, data management experts, data security experts, and data analysts and biostatisticians) examined evolving best practices among sponsors and investigators and probed solutions to specific technical issues that have continued to challenge studies relying on mobile devices for data capture.
Additional insights will be gathered at a multi-stakeholder expert meeting, after which CTTI will release recommendations designed to overcome the challenges hindering the wider use of mobile technologies in clinical trials.
In June 2017, CTTI convened a multi-stakeholder expert meeting to explore solutions to the scientific and technological challenges of using mobile devices in clinical trials. Themes from the meeting included:
A meeting summary is available that highlights themes from these discussions.
|Executive Committee Champion||John Hubbard||Bioclinica|
|Project Manager||Jen Goldsack||CTTI|
|Social Science Lead||Amy Corneli||CTTI|
|Team Leader||Seleen Ong*||Pfizer|
|Team Leader||Ken Babamoto*||Pfizer|
|Team Leader||Marisa Bolognese||The Life Raft Group|
|Team Leader||Phil Coran||Medidata Solutions|
|Team Leader||Christopher Dell||Pfizer|
|Team Leader||Ray Dorsey||URMC|
|Team Leader||Cheryl Grandinetti||U.S. Food and Drug Administration|
|Team Leader||Kaveeta Vasisht||U.S. Food and Drug Administration|
|Team Member||Barry Peterson||Philips Respironics|
|Team Member||Jessie Bakker||Philips Respironics|
|Team Member||Aaron Coleman||Fitabase|
|Team Member||Ernesto Ramirez||Fitabase|
|Team Member||Adam Amdur||Sleep Apnea Association|
|Team Member||Aiden Doherty||University of Oxford|
|Team Member||Jonathan Helfgott||Johns Hopkins University|
|Team Member||Matthew Kirchoff||National Institutes of Health|
|Team Member||Phil Kronstein||U.S. 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||Tom Switzer||Genentech - A Member of the Roche Group|
|Team Member||Evan Wearne||U.S. Food and Drug Administration|