The Clinical Trials Transformation Initiative (CTTI) has released new recommendations which emphasize considerations that are important for trials incorporating mobile technologies, explained CTTI Executive Director Pamela Tenaerts.
The recommendations stress the importance of engaging patient and sites early and often throughout a mobile clinical trial — “that is critical to success,” Tenaerts told us.
Additionally, she said mobile technology should not add “undue burden,” and steps should be taken to ensure any anticipated burdens are offset with corresponding benefits. Additionally, the use of mobile technology should provide value to both participants as well as researchers, according to the recommendations.
“Investigators see mobile technology as bringing substantial value to research. At the same time, the use of mobile technologies can increase the logistical burden on investigative sites—it is important to recognize and plan for these burdens during the budgeting and contracting process and throughout trial execution,” explained Tenaerts.
The recommendations – the fourth in CTTI’s Mobile Clinical Trials (MCT) Program – align with the 21st Century Cures Act, the US Food and Drug Administration (FDA) Reauthorization Act of 2017 (FDARA), and the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI).
“The use of mobile technologies holds the promise and potential for higher quality, more efficient clinical trials. However, to maximize opportunities and minimize challenges associated with mobile technologies, it is critical to understand the perspectives of patients and investigative site personnel and incorporate those perspectives into trial design and execution,” Tenaerts said.
The organization last year provided recommendations to help researchers deploy mobile technologies in clinical trials – guidance that helps “pave the way” for improving how the industry develops medicines, a Pfizer executive told us at the time.
Additionally, CTTI in 2017 released recommendations for developing novel endpoints generated by mobile technologies.
All of the recommendations have been developed with input from various stakeholders, such as potential research participants and site investigators.