The Clinical Trials Transformation Initiative (CTTI) announced the recommendations recently during a special event at the US Food and Drug Administration’s (FDA) White Oak Campus.
Pamela Tenaerts, executive director, CTTI said the recommendation outline an approach that has the potential to increase the quality and efficiency of clinical trials.
The recommendations offer guidance for selecting appropriate mobile technologies and capturing complete, attributable, and high-quality data, as well as managing data. It also addresses protocol design and preparing for FDA submission and inspection.
CTTI defines mobile technologies as mobile applications and other wearables, ingestibles, implantables, and portable technologies containing sensors for the remote capture of outcomes data.
“Our new recommendations and resources—including case examples and decision tools—offer practical guidance for using mobile technologies in clinical trials, from selecting a technology at the beginning of a trial to preparing for FDA submission using data generated from the technology,” Tenaerts told us.
The recommendations were developed by a multi-stakeholder group, including regulators, sponsors, academic medical centers, technology companies, and patients, among others.
Tenaerts said, “The clinical research community has long discussed an exciting future of using mobile technologies to collect objective, reliable data in clinical trials—now, we can make this vision a reality.”
As she explained, the recommendations provide a pathway for using mobile technologies to capture more informative real-world data from patients, reduce barriers to trial participation, and lower costs associated with conducting clinical trials.
“Sponsors and service providers now have valuable information to meet technical requirements, support collaborations, and understand each other’s needs and expectations,” she added.
Response: FDA, Pfizer, Verily
Owen Faris, clinical trials director in the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said the recommendations will help complement the FDA’s efforts “to help to bridge a gap in the widespread adoption of mobile technologies for data capture in clinical trials.”
“To date, leveraging mobile technologies for data capture in clinical trials has been a daunting effort—mainly because much of the work is unprecedented,” added Seleen Ong, clinical sciences group lead for global product development at Pfizer.
With the new recommendations, Ong said the industry now has “a practical and user-friendly” road map, one which she looks forward to using. “We look forward to using this guidance to efficiently employ mobile technologies in clinical trials and pave the way for improving how we develop medicines,” she added.
Robert Califf, vice chancellor for health data science at Duke Health and adviser at Verily Life Sciences said the latest recommendations “provide approaches for the enterprise to move forward with mobile technology innovations that will help improve data quality and reduce costs in clinical research.”
The recommendations are CTTI’s second, following its 2017 release of recommendations for developing novel endpoints generated by mobile technologies.
Looking ahead, Tenaerts said the initiative also will announce recommendations “to overcome challenges associated with conducting decentralized trials in the US, and addressing patients’ and investigators’ needs regarding the use of mobile technologies in clinical trials.”