Program: Mobile Clinical Trials (MCT)

About This Program

Project:

Engaging Patients and Sites

overview icon Overview

Adoption of mobile technologies for use in clinical trials relies on positive reception from key stakeholders; yet, until now, little was known about how to engage patients and research sites when planning and conducting mobile clinical trials.

CTTI’s Mobile Clinical Trials (MCT) Engaging Patients and Sites recommendations and resources fills that gap by addressing the concerns, perceived advantages, and preferences of sites and patients. Using these resources, sponsors, contract research organizations, and other stakeholders can maximize the opportunities of mobile technologies to advance the development of new medical products.

 

 

in detail icon In Detail

Understanding patients’ and site investigators’ familiarity with mobile technologies, as well as their concerns and perceived advantages to using these technologies in clinical trials, is critical to maximizing benefits and minimizing barriers to participation in clinical trials that incorporate these technologies. Previously, information was sparse on how these stakeholders perceived the use of mobile technologies within clinical trials; therefore, CTTI conducted research to assess their perceptions and identify strategies for overcoming barriers.

Mobile Clinical Trials Program: Engaging Patients and Sites (2015 – 2019)

View other projects within CTTI’s MCT Program.

Among potential research participants:

  • Determine familiarity and ease of use with mobile technologies
  • Identify perceived concerns and advantages 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 technologies)

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

The project team conducted a survey among 193 potential research participants to determine their willingness to participate in mobile clinical trials, preferred attributes of mobile technologies, 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 technologies 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 technologies 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 technologies 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 technologies in clinical trials. At the meeting, attendees underscored that successful adoption of mobile technologies 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 technologies are 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 mobile technologies 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.

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

Project Team Members

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