Patients Help Improve Mobile Clinical Trial Designs
“Very little was known about patients’ and sites’ perspectives until our work shed light on what they see as significant benefits and barriers,” says Pamela Tenaerts, CTTI executive director. “Our new recommendations account for these perspectives and provide a valuable resource for optimally deploying mobile clinical trials.”
CTTI conducted surveys and in-depth interviews to better understand the viewpoints of patients and clinical investigators. They convened experts and leaders across the clinical trials enterprise to develop recommendations and resources.
The resulting recommendations are designed to assist research sponsors in:
- Engaging patient and site perspectives in planning clinical trials using mobile technologies, including protocol design, technology selection and pilot testing
-
Maximizing value and minimizing burdens for patients, including:
- setting patient expectations
- protecting privacy
- returning individual data
- enhancing patient-site interactions
- providing technical support
- Addressing site challenges, including contracting, budgeting and training.
“One of the key takeaways of CTTI’s work is the importance of engaging both patients and sites early, often and throughout a mobile clinical trial,” says Angela Botto-van Bemden, director of osteoarthritis programs at the Arthritis Foundation. “These new resources provide practical tools for communicating with stakeholders and ensuring their needs are factored into critical decisions, from technology selection to trial design to data dissemination.”
The use of these technologies has the potential to enhance clinical trial quality and efficiency by allowing remote participation, increasing protocol adherence and facilitating inclusion of a more diverse population. More information about CTTI’s recommendations can be found at the the Mobile Clinical Trials program’s Engaging Patients and Sites project.
The Arthritis Foundation is one of more than 80 organizations collaborating through CTTI. We currently work with CTTI on joint projects that include Mobile Clinical Trials and Real World Evidence.