New Recommendations and Resources Provide Road Map for Using Mobile Technologies for Data Capture in Clinical Research

 

In a special event today at the U.S. Food and Drug Administration’s (FDA) White Oak Campus, CTTI unveiled new recommendations for the use of mobile technologies in clinical research. The evidence-based recommendations and resources address an unmet need by outlining best practices for the use of mobile devices and applications to capture objective data—an approach that has the potential to increase the quality and efficiency of clinical trials.

 

“The clinical research community has long discussed an exciting future of using mobile technologies to collect objective, reliable data in clinical trials,” said CTTI Executive Director Pamela Tenaerts. “Today, we are excited to start making this vision a reality—sharing recommendations for capturing more informative real-world data from patients, reducing barriers to trial participation, and lowering costs associated with conducting clinical trials.”

 

The full set of recommendations and resources includes case examples and decision tools that offer practical guidance for:

 

• Selecting mobile technologies for data capture that are appropriate to the trial.
• Capturing complete, attributable, and high-quality data.
• Managing the data generated by mobile technologies—including safety considerations, data integrity, and security issues.
• Designing and executing a protocol that uses mobile technologies for data capture.
• Preparing for FDA submission and inspection.

 

This is the second set of recommendations from CTTI’s Mobile Clinical Trials Program for FDA-regulated trials. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies. Later this year, recommendations will be released addressing patients’ and investigators’ needs regarding the use of mobile technologies in clinical trials and overcoming challenges to conducting decentralized trials in the U.S.

Thank you for your interest in CTTI’s Mobile Technologies Event. As of June 8, seating is full for this event. We hope you can join us for the live stream from FDA’s White Oak Campus on July 16.

 

The use of mobile technologies for data capture has the potential to transform clinical trials. What has been missing is a clear road map for making this vision a reality. This will change on July 16.

Leaders in clinical trials and mobile technologies will gather for a special event at the U.S. Food and Drug Administration’s (FDA) White Oak Campus, where CTTI will unveil its new Mobile Technologies recommendations. Representatives from the multi-stakeholder group of experts who developed the recommendations will offer insights and practical guidance throughout the day.

The event will culminate with an engaging panel discussion on the future of mobile technologies in clinical trials. Panelists will include Francesca Cerreta of the European Medicines Agency; Ray Dorsey of the University of Rochester Medical Center; Pat Furlong of Parent Project Muscular Dystrophy; John Hubbard of Genstar Capital; and Leonard Sacks of the FDA.

MORE INFORMATION

• Date and Time: Mon., July 16, 2018; 9:30 a.m. – 5:00 p.m. (Add to Calendar)
• Location: FDA, White Oak Campus,  Silver Spring, Md.

Objectives:

• Selecting mobile technologies for data capture that are appropriate to the trial.
• Capturing complete, attributable, and high-quality data.
• Managing the data generated by mobile technologies—including safety considerations, data integrity, and security issues.
• Designing and executing a protocol that uses mobile technologies for data capture.
• Preparing for FDA submission and inspection.

Visit the project webpage to view the full set of Mobile Technologies recommendations and resources. 

A CTTI article recently published in Digital Biomarkers investigates the use of mobile devices to measure outcomes in clinical research from 2010-2016. The article provides a detailed accounting of where the field is currently, allowing researchers to see what measures exist for using or developing technology-derived endpoints, how they are being used, and how to access relevant literature.

The review found that, while mobile devices are widely used to assess outcomes in observational research, their use in interventional research is limited. Additionally, the absence of standardization across the measures used to assess outcomes of interest, units of measurement, sampling rate, device placement, and the technologies themselves indicates a pressing need for standards to interpret and compare results across studies and across therapeutic areas.

The article offers suggestions for incorporating mobile technology into interventional research—such as consolidating evidence supporting the clinical meaningfulness of specific technology-derived endpoints, and standardizing the use of mobile devices in clinical research to measure these endpoints.

The review also found that:

• The majority of technology-derived novel endpoints are currently being used in cardiac studies. However, in randomized controlled trials, technology-derived novel endpoints are most commonly used in Type I diabetes studies.
• Physical activity measures are the most commonly used technology-derived endpoints in clinical studies. Other commonly used endpoints are related to sleep, mobility, and pill adherence, as well as biomarkers such as cardiac, glucose, gastric reflux, respiratory measures, and intensity of head-related injury.
• There is a scarcity of technology-derived measures being used as actual outcome assessments in studies of neurological diseases such as Parkinson’s and Alzheimer’s, which have a considerable unmet need for measures. Oncology and nephrology are two other key therapeutic areas with unmet need for better assessments, but a dearth of technology-derived measures.