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CTTI Unveils Recommendations for Using Mobile Technologies in Clinical Research

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 a 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.