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

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

doi:10.1159/000503957

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

Digit Biomark. 2019 Nov 6;3(3):145-154. doi: 10.1159/000503957. eCollection 2019 Sep-Dec.

Authors

Philip Coran¹, Jennifer C Goldsack^{2

3}, Cheryl A Grandinetti⁴, Jessie P Bakker⁵, Marisa Bolognese⁶, E Ray Dorsey⁷, Kaveeta Vasisht⁴, Adam Amdur⁸, Christopher Dell⁹, Jonathan Helfgott¹⁰, Matthew Kirchoff¹¹, Christopher J Miller¹², Ashish Narayan¹³, Dharmesh Patel¹⁴, Barry Peterson¹⁵, Ernesto Ramirez¹⁶, Drew Schiller¹⁷, Thomas Switzer¹⁸, Liz Wing¹⁹, Annemarie Forrest², Aiden Doherty^{20

21}

Affiliations

¹ Medidata Solutions, New York, New York, USA.
² Clinical Trials Transformation Initiative, Durham, North Carolina, USA.
³ Digital Medicine (DiMe) Society, New York, New York, USA.
⁴ Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
⁵ Philips, Monroeville, Pennsylvania, USA.
⁶ The Life Raft Group, Wayne, New Jersey, USA.
⁷ Center for Health and Technology and Department of Neurology, University of Rochester Medical Center, Rochester, New York, USA.
⁸ American Sleep Apnea Association, Washington, District of Columbia, USA.
⁹ Pfizer Inc., Collegeville, Pennsylvania, USA.
¹⁰ Johns Hopkins University, Baltimore, Maryland, USA.
¹¹ National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
¹² AstraZeneca, Gaithersburg, Maryland, USA.
¹³ Icahn School of Medicine, Mount Sinai Health System, New York, New York, USA.
¹⁴ Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, USA.
¹⁵ Independent Consultant, Fort Mill, South Carolina, USA.
¹⁶ Evidation Health, San Mateo, California, USA.
¹⁷ Validic, Durham, North Carolina, USA.
¹⁸ Genentech Inc., South San Francisco, California, USA.
¹⁹ Duke Clinical Research Institute, Durham, North Carolina, USA.
²⁰ Big Data Institute, Li Ka Shing Centre for Health Information and Discovery, University of Oxford, Oxford, United Kingdom.
²¹ National Institute for Health Research, Oxford Biomedical Research Centre, Oxford University Hospitals National Health Service Foundation Trust, John Radcliffe Hospital, Oxford, United Kingdom.

Abstract

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.

Keywords: Clinical trials; Mobile technologies; Regulatory approval; Wearable sensors.

Abstract

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