Program: Mobile Clinical Trials (MCT)

About This Program

Project:

Stakeholder Perceptions

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Stakeholder Perceptions of the Use of Mobile Technology in Clinical Trials

Adoption of mobile technology 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 trial participants. Early evidence-gathering activities conducted by CTTI suggest that key stakeholders may be more engaged in clinical trials when mobile technology is used; therefore, it is important to ensure their needs and concerns with using mobile technology are met.

The goal of this project within CTTI’s MCT Program is to propose recommendations to overcome barriers to the use of mobile technology in clinical trials as perceived by key stakeholders, including site investigators and potential research participants. The scope of the program includes use of mobile technology in FDA-regulated clinical trials after the time of participant consent.

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Understanding key stakeholders’ familiarity with mobile technology as well as their concerns with using such technology is critical to ensuring their adherence to the technology and limiting the burden of participation in clinical trials. Currently, information is sparse on how stakeholders feel about the use of mobile technologies within clinical trials; therefore, CTTI plans to explore the perceptions of key stakeholders regarding its use to allow for the identification of strategies for overcoming barriers.

Mobile Clinical Trials Program: Patient, Caregiver, Investigator and Provider Perceptions of the Use of Mobile Technology in Clinical Trials (2015 – ongoing)

CLICK HERE to 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.

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

Project Team Members

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