REMOTE

• Year Posted: 2011
• Sponsor: Pfizer Inc.
• Disease: Overactive Bladder
• Intervention: Tolterodine ER versus Placebo
• Phase: Phase 4
• Digital Health Technology: Web-based trial design

REMOTE was the first randomized clinical trial using Web and mobile phone-based “patient recruitment, enrollment, and collection of study data without requiring patients to visit a physical study site” (Jhadhav, 2016). REMOTE was unable to recruit enough patients as most of the target patient group was older and less literate with the technology being used (Jhadhav, 2016), illustrating the need to appropriately use digital health technology in a trial. For more information on the trial, please view the study record (ClinicalTrials.gov, 2013).

VERKKO

• Year Posted: 2015
• Sponsor: Sanofi
• Disease: Diabetes
• Intervention: Observational
• Phase: Phase 4
• Digital Health Technology: Web-based and 3G-enabled wireless blood glucose meter

This study tested the use of an online platform and a 3G-capable, wireless glucose meter. VERKKO was the first clinical trial using an electronic informed consent approved by European regulatory agencies and indicated that compliance, convenience, and retention can increase by using a virtual platform (Business Wire, 2016; CenterWatch, 2017).

ALS AT HOME

• Year Posted: 2017
• Sponsor: Barrow Neurological Institute
• Disease: Amyotrophic lateral sclerosis (ALS)
• Intervention: Observational study
• Phase: Information not available
• Digital Health Technology: 3G-enabled biological functioning meters

A single-center study of up to 150 participants is being conducted to determine “the extent to which frequent sampling can improve the qualities of outcome measures collected at home by study participants” (ClinicalTrials.gov, 2018c). This study is yet to be completed, but potential benefits include increasing data measurement frequency and increased convenience for ALS patients who may have difficulty visiting a study center to be part of the trial (Barrow Nerulogical Institute, 2017). For more information, please view the study record (ClinicalTrials.gov, 2018c).

Sanofi/Science 37 Partnership

Sanofi has partnered with Science 37, a remote research technology company, to allow patients to participate from the comfort of their own homes and report data via an Apple iPhone, which is equipped with Science 37's Networked Oriented Research Assistant (NORA^®). Participants will be provided with a phone, other sensors needed for the trial, and medicines being researched. Study mobile devices allow participants to reach study staff at any time. Furthermore, patients' data are sent directly to researchers, who have ready access to the data. This process can eliminate months of searching for participants and travel time to study sites (Adams, 2017; CenterWatch, 2017).

Novartis/Science 37 Partnership

Novartis has partnered with Science 37 to boost its ability to run “remote trials.” Its partnership plans to “launch up to 10 trials, with increasing decentralization over 3 years” (Adams, 2018). Set to begin in late 2018 in the United States, trials will focus on dermatology, neuroscience, and cancer. Novartis will leverage Science 37's NORA^® technology to facilitate remote collection of data. Novartis is no stranger to this approach and has used a “virtual approach” for cluster headaches, acne, and non-alcoholic steatohepatitis (Adams, 2018; Taylor, 2018).

UCB/Science 37 Partnership

UCB has announced a partnership with Science 37 to bring clinical trials into participants' homes. UCB plans to use Science 37's NORA platform to evaluate its Neupro^® patch in pediatric restless leg syndrome (following its approval for adults). The trial plans to enroll 138 participants and will track their sleep, impact of the disease, and quality of life using the app (Hale, 2018).