CTTI Unveils New Recommendations for Incorporating Patient and Site Perspectives in Mobile Trials

CTTI released new recommendations and resources today for engaging patients and sites when planning clinical trials using mobile technologies. These recommendations have the potential to help sponsors, CROs, and other stakeholders gain the full benefits of using mobile technologies in clinical trials, including remote participation, increased protocol adherence, and participation by a more diverse population.

While buy-in from stakeholders is critical to the success of mobile trials, little was known about patient and site perspectives until CTTI conducted surveys and interviews with patients and investigative site personnel to assess perceived benefits and barriers.

The resulting recommendations have the potential to help research sponsors:

• Engage patients and sites in protocol design, technology selection, and pilot testing
• Maximize value and minimize burden for study participants by setting patient expectations, protecting privacy, returning data, enhancing patient-site interactions, and providing technical support
• Address challenges for investigative sites, from contracting and budgeting to evaluating site readiness and implementing effective and streamlined training

“CTTI’s recommendations and resources are designed to take our understanding of patient and site needs in mobile clinical trials to the next level,” said Bill Wood, associate professor at the School of Medicine at the University of North Carolina at Chapel Hill. “With these new insights, sponsors and researchers can plan and conduct mobile trials that work better for everyone involved, streamlining the clinical research process and accelerating the development of critical new therapies.”

The recommendations are the fourth set generated through CTTI’s Mobile Clinical Trials (MCT) Program, following recommendations on developing novel endpoints generated by mobile technologies, using mobile technologies for data capture in clinical trials, and planning and conducting decentralized clinical trials. Additionally, they build on previous CTTI work—including our Quality by Design and Patients Groups and Clinical Trials recommendations—that emphasizes the involvement of many stakeholders, including patients and sites, in trial design.