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

2019; Karger Publishers; Volume: 3; Issue: 3 Linguagem: Inglês

10.1159/000503957

2504-110X

Philip Coran, Jennifer C. Goldsack, Cheryl Grandinetti, Jessie P. Bakker, Marisa Bolognese, E. Ray Dorsey, Kaveeta P. Vasisht, Adam Amdur, Christopher A. Dell, Jonathan Helfgott, Matthew Kirchoff, Christopher J. Miller, Ashish Narayan, Dharmesh K. Patel, Barry W. Peterson, Ernesto Ramirez, Drew Schiller, Thomas Switzer, Liz Wing, Annemarie Forrest, Aiden Doherty,

Ethics in Clinical Research

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.