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.
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:
Among site investigators who have been involved 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.
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.
|Executive Committee Champion & Team Leader||Virginia Nido||Genentech - a member of the Roche Group|
|Project Manager||Zach Hallinan||Clinical Trials Transformation Initiative|
|Social Science Lead||Amy Corneli||Clinical Trials Transformation Initiative|
|Team Leader||William Wood||University of North Carolina-Chapel Hill|
|Team Leader||Cindy Geoghegan||Individual Patient/Caregiver|
|Team Leader||Steve Morin||Food and Drug Administration|
|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||Boehringer Ingelheim|
|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 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|