Open AccessAdvancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative
Author(s) -
Coran Philip,
Goldsack Jennifer C.,
Grandinetti Cheryl A.,
Bakker Jessie P.,
Bolognese Marisa,
Dorsey E. Ray,
Vasisht Kaveeta,
Amdur Adam,
Dell Christopher,
Helfgott Jonathan,
Kirchoff Matthew,
Miller Christopher J.,
Narayan Ashish,
Patel Dharmesh,
Peterson Barry,
Ramirez Ernesto,
Schiller Drew,
Switzer Thomas,
Wing Liz,
Forrest Annemarie,
Doherty Aiden
Publication year - 2019
Publication title -
digital biomarkers
Language(s) - English
Resource type - Journals
ISSN - 2504-110X
DOI - 10.1159/000503957
Subject(s) - viewpoint research article
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.