Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative.

Mobile technologies offer the potential to reduce the costs of conducting clinical trials by collecting high-quality information on health outcomes in real-world settings that are relevant to patients and clinicians. However, widespread use of mobile technologies in clinical trials has been impeded by their perceived challenges. To advance solutions to these challenges, the Clinical Trials Transformation Initiative (CTTI) has issued best practices and realistic approaches that clinical trial sponsors can now use. These include CTTI recommendations on technology selection; data collection, analysis, and interpretation; data management; protocol design and execution; and US Food and Drug Administration submission and inspection. The scientific principles underpinning the clinical trials enterprise continue to apply to studies using mobile technologies. These recommendations provide a framework for including mobile technologies in clinical trials that can lead to more efficient assessment of new therapies for patients.

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Copyright © 2019 by S. Karger AG, Basel.

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J.C.G., C.A.G., J.P.B., M.B., K.V., A.A., C.D., J.H., M.K., A.N., D.P., T.S., L.W., and A.D. have no conflicts of interest to declare. P.C. is an employee of Medidata Solutions with ownership interests. E.R.D. has received honoraria for speaking at American Academy of Neurology courses, American Neurological Association, and University of Michigan; received compensation for consulting services from 23andMe, Abbott, Abbvie, American Well, Biogen, Clintrex, DeciBio, Denali Therapeutics, GlaxoSmithKline, Grand Rounds, Karger, Lundbeck, MC10, MedAvante, Medical-legal services, Mednick Associates, National Institute of Neurological Disorders and Stroke, Olson Research Group, Optio, Prilenia, Putnam Associates, Roche, Sanofi, Shire, Sunovion Pharma, Teva, UCB, and Voyager Therapeutics; research support from Abbvie, Acadia Pharmaceuticals, AMC Health, Biosensics, Burroughs Wellcome Fund, Davis Phinney Foundation, Duke University, Food and Drug Administration, GlaxoSmithKline, Greater Rochester Health Foundation, Huntington Study Group, Michael J. Fox Foundation, National Institutes of Health/National Institute of Neurological Disorders and Stroke, National Science Foundation, Nuredis Pharmaceuticals, Patient-Centered Outcomes Research Institute, Pfizer, Prana Biotechnology, Raptor Pharmaceuticals, Roche, Safra Foundation, Teva Pharmaceuticals, University of California Irvine; editorial services for Karger Publications; and ownership interests with Blackfynn (data integration company) and Grand Rounds (second opinion service). C.J.M. is an employee of AstraZeneca and a shareholder of AstraZeneca, Abbott, Abbvie, and J&J. B.P. was at Philips Respironics from 2011 to 2017. D.S. has ownership interests in Validic. E.R. is an employee of Evidation Health. J.P.B. has been a full-time employee at Philips since 2017.