Program: Mobile Clinical Trials (MCT)

About This Program

Project:

Stakeholder Perceptions

overview icon Overview

Stakeholder Perceptions of the Use of Mobile Technology in Clinical Trials

Adoption of mobile technology for use in clinical trials relies on positive reception from key stakeholders; yet, little is known about the possible barriers and facilitators of its use from the perspectives of clinical investigators and research participants. The goal of CTTI’s Stakeholder Perceptions Project within the Mobile Clinical Trials (MCT) Program is to evaluate perceptions of the use of mobile technology in FDA-regulated clinical trials in order to overcome perceived obstacles and facilitate adoption.

As part of this project, CTTI conducted a survey of potential research participants and in-depth interviews with investigators to assess their concerns and better understand perceived benefits. CTTI also convened an expert meeting to explore issues critical to acceptance by key stakeholders, including involving patients early and often in trial planning and design; ensuring that participants remain engaged and are able to easily communicate with site staff; selecting and tailoring devices based on study design; and addressing the unique concerns that stakeholders have around mobile clinical trials, including patient confidentiality, missing or inaccurate data, maintaining patient engagement, and a lack of uniformity among processes, devices, and platforms. As a next step, CTTI will work with stakeholders to develop recommendations to address barriers to, and incorporate preferences for, the use of mobile technology in clinical trials.

 

 

in detail icon In Detail

Understanding patients’ and site investigators’ familiarity with mobile technology as well as their concerns with using such technology is critical to encouraging adoption and limiting the burden of participation in clinical trials. Currently, information is sparse on how these stakeholders perceive the use of mobile technologies within clinical trials; therefore, CTTI is working to explore their perceptions and identify strategies for overcoming barriers.

Mobile Clinical Trials Program: Stakeholder Perceptions of the Use of Mobile Technology in Clinical Trials (2015 – ongoing)

View other projects within CTTI’s MCT Program.

Among potential research participants:

  • Determine familiarity and ease of use with mobile technologies
  • Identify perceived concerns of using mobile technologies to collect and share personal data in clinical trials
  • Identify preferred and undesirable attributes of mobile technologies when used in clinical trials
  • Determine the acceptability of and willingness to participate in clinical trials that use mobile technologies (and how those might be different from trials without use of mobile technology)

Among site investigators who have been involved in mobile clinical trials:

  • Describe site investigators’ insights on the advantages and disadvantages of mobile clinical trials
  • Explain site-level budgetary, training, and other support needs necessary to adequately prepare for and implement mobile clinical trials
  • Describe site investigators’ advice for other site investigators who are interested in participating in mobile clinical trials

Results from this project will encourage high-quality, efficient trials that successfully leverage the use of mobile technology in ways that incorporate the needs and expectations of potential research participants and site investigators.

What evidence has been gathered to assess patient and investigator perceptions?

  • Survey of potential research participants
  • In-depth interviews with site investigators
  • Expert meeting

What are the findings from this project?

The MCT Stakeholder Perceptions Project team conducted a survey among 193 potential research participants to determine their willingness to participate in mobile clinical trials, preferred attributes of mobile devices, and concerns and preferences regarding data privacy and communications. When presented with both mobile and traditional versions of the same trial, 76% of respondents said they preferred to participate in the mobile trial. Those who preferred the mobile trial said it would require less time and effort, reduce clinic visits, facilitate more accurate data collection, and allow patients to track their own health data. Respondents also said they would be willing to use a variety of mobile devices and that data confidentiality is important.

The project team also conducted in-depth interviews with investigators who had been involved in mobile clinical trials to determine perceived advantages and disadvantages of using mobile technology in trials, site needs and requirements, and lessons learned. Perceived advantages included the potential for continuous, high-frequency collection of real-world data, reduced burden on study participants, and improved ability to streamline study operations by allowing participants to be recruited, enrolled, and managed remotely. Key disadvantages included increased time and labor spent managing devices, the learning curve that accompanies the adoption of new technology, and the increased reliance on participants using devices as instructed for accurate data collection.

An expert meeting (see summary) was held Jan. 9-10, 2018, to review findings from these activities and discuss how the evidence gathered could be used to provide direction to the research enterprise for the appropriate use of mobile technology in clinical trials. At the meeting, attendees underscored that successful adoption of mobile technology requires rethinking how trials are designed and conducted. At the same time, they noted that many of the factors that define high-quality trial design remain the same, whether or not mobile technology is used. They also agreed on the importance of involving patients early and often in trial planning and design; ensuring that participants remain engaged and are able to easily communicate with site staff; selecting and tailoring devices based on study design; and addressing the unique concerns that stakeholders have around mobile clinical trials, including patient confidentiality, missing or inaccurate data, maintaining patient engagement, and a lack of uniformity among processes, devices, and platforms.

  • Survey of potential research participants
  • In-depth interviews with site investigators
  • Expert meeting

Project Team Members

Role Name Affiliationsort descending
Team Member Guy Eakin* Arthritis Foundation
Team Member Angie Botto-van Bemden Arthritis Foundation
Team Member Terri Hinkley* Association of Clinical Research Professionals
Team Member Hassan Kadhim Boehringer Ingelheim
Team Member Annick Anderson* CISCRP
Project Manager Zach Hallinan Clinical Trials Transformation Initiative
Social Science Lead Amy Corneli Clinical Trials Transformation Initiative
Team Member Ricky Bloomfield* Duke University
Team Member Kristine Nelson* EMMES
Team Member Ken Skodacek Food and Drug Administration
Team Member Junyang Wang Food and Drug Administration
Team Member Immo Zadezensky* Food and Drug Administration
Team Leader Steve Morin Food and Drug Administration
Team Member Ido Paz-Priel Genentech - a member of the Roche Group
Executive Committee Champion & Team Leader Virginia Nido Genentech - a member of the Roche Group
Team Member Amanda Niskar Individual Patient/Caregiver
Team Leader Cindy Geoghegan Individual Patient/Caregiver
Team Member Sue Dubman Individual Patient/Caregiver
Team Member Kara Dennis* Medidata Solutions
Team Member Paul O'Donohoe Medidata Solutions
Team Member Petros Okubagzi Medstar Health Research Institute
Team Member David Brennan* Medstar Health Research Institute
Team Member Les Jordan Target Health, Inc
Team Member Maria Ali The George Institute
Team Leader William Wood University of North Carolina-Chapel Hill
Team Member Dave Borasky WIRB-Copernicus IRB