Program: Mobile Clinical Trials (MCT)

About This Program

Project:

Mobile Technologies

overview icon Overview

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.

in detail icon In Detail

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 Considerations:

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

Scientific Considerations:

  • Providing real-time data to study participants   
  • Monitoring outcomes
  • Real-time safety signals

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.

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:

  • Best practices for studies using mobile devices for data capture do not differ significantly from many of the best practices already applied to clinical trials.
  • Studies using mobile devices for data capture should not be held to higher standards than traditional trials.
  • This effort should strive to engage patients in study design.
  • Existence of the technology should not drive the decision to incorporate a mobile device for data capture—rather, that decision should follow the identification of a technology-derived measure that is better than existing alternatives.
  • The device should be fit for the purpose of collecting data to support the endpoint for the particular patient population. 

A meeting summary is available that highlights themes from these discussions.

Project Team Members

Role Name Affiliationsort descending
Team Member Chris Miller AstraZeneca Pharmaceuticals LP
Project Manager Jen Goldsack Clinical Trials Transformation Initiative
Social Science Lead Amy Corneli Clinical Trials Transformation Initiative
Team Member Ashish Narayan Feinstein Institute for Medical Research
Team Member Aaron Coleman Fitabase
Team Member Ernesto Ramirez Fitabase
Team Member Dharmesh Patel Food and Drug Administration
Team Member Evan Wearne Food and Drug Administration
Team Leader Cheryl Grandinetti Food and Drug Administration
Team Leader Kaveeta Vasisht Food and Drug Administration
Team Member Phil Kronstein Food and Drug Administration
Team Member Tom Switzer Genentech - a member of the Roche Group
Executive Committee Champion John Hubbard Genstar Capital
Team Member Jonathan Helfgott Johns Hopkins University
Team Leader Phil Coran Medidata Solutions
Team Member Matthew Kirchoff National Institutes of Health
Team Leader Seleen Ong* Pfizer, Inc
Team Leader Ken Babamoto* Pfizer, Inc
Team Leader Christopher Dell Pfizer, Inc
Team Member Barry Peterson Philips Respironics
Team Member Jessie Bakker Philips Respironics
Team Member Adam Amdur Sleep Apnea Association
Team Leader Marisa Bolognese The Life Raft Group
Team Member Aiden Doherty University of Oxford
Team Leader Ray Dorsey URMC