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Appendix C Examples of Virtual Clinical Trials Included in Workshop Handout COMPLETED TRIALS REMOTE â¢ Year Posted: 2011 â¢ Sponsor: Pfizer Inc. â¢ Disease: Overactive Bladder â¢ Intervention: Tolterodine ER versus Placebo â¢ Phase: Phase 4 â¢ Digital Health Technology: Web-based trial design REMOTE was the first randomized clinical trial using web and mobile phone-based âpatient recruitment, enrollment, and collection of study data without requiring patients to visit a physical study siteâ (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 using digital health technology in a trial. For more information on the trial, please view the study record (ClinicalTrials.gov, 2013). VERKKO â¢ Year Posted: 2015 â¢ Sponsor: Sanofi â¢ Disease: Diabetes â¢ Intervention: Observational â¢ Phase: Phase 4 â¢ 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). PREPUBLICATION COPY: UNCORRECTED PROOFS 81
82 VIRTUAL CLINICAL TRIALS: CHALLENGES AND OPPORTUNITIES A Computerized Intervention for Depression â¢ Year Posted: 2016 â¢ Sponsor: William Stone â¢ Disease: Depression â¢ Intervention: Behavioralâinteractive, media-based problem-solving treatment â¢ Phase: Not applicable â¢ Digital Health Technology: Computer based This study was entirely automated and did not require involvement of a live clinician, with the goal of providing access to participants who did not have access to traditional therapy due to living conditions or individual preferences. The computer-based treatment offered several advantages, such as the ability to use it anywhere and its standardized and consistent approach. For more information, please view the study record (ClinicalTrials.gov, 2017a). ONGOING TRIALS ALS AT HOME â¢ Year Posted: 2017 â¢ Sponsor: Barrow Neurological Institute â¢ Disease: Amyotrophic lateral sclerosis (ALS) â¢ Intervention: Observational study â¢ Phase: Information not available â¢ Digital Health Technology: 3G-enabled biological functioning meters A single-center study of up to 150 participants is being conducted to determine âthe extent to which frequent sampling can improve the qualities of outcome measures collected at home by study participantsâ (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). Virtual-PND â¢ Year Posted: 2017 â¢ Sponsor: Womenâs College Hospital â¢ Disease: Perinatal depression â¢ Intervention: Behavioral â¢ Phase: Not applicable â¢ Digital Health Technology: Teleclinician visit This study consists of 12 weeks of supplemental real-time clinician video visits. Though the initial goal is to demonstrate the feasibility of a large-scale randomized controlled trial evaluation of virtual psychiatric care, this study will also inform the effectiveness of providing virtual psychiatric care. For more information, please view the study record (Clinicaltrials.gov, 2017d). PREPUBLICATION COPY: UNCORRECTED PROOFS
APPENDIX C 83 ELECTOR Treat-to-Target Via Home-Based Disease Activity Monitoring of Patients with Rheumatoid Arthritis â¢ Year Posted: 2018 â¢ Sponsor: Frederiksberg University Hospital â¢ Disease: Rheumatoid arthritis â¢ Intervention: Observational â¢ Phase: Not applicable â¢ Digital Health Technology: Telemonitoring This study is using telemonitoring tools to manage treatment of rheumatoid arthritis. It will furthermore assess if a virtual approach for home-based monitoring is superior to standard clinical monitoring strategy. For more information, please view the study record (ClinicalTrials.gov, 2018d). Enhancing Quality of Life Through Exercise: A Telerehabilitation Approach â¢ Year Posted: 2016 â¢ Sponsor: McGill University â¢ Disease: Spinal cord injury â¢ Intervention: Behavioralâphysical activity intervention â¢ Phase: Not applicable â¢ Digital Health Technology: Video-based telerehabilitation This study will evaluate video-based telerehabilitation intervention to enhance basic psychological needs, motivation, physical activity, and quality-of-lifeârelated outcomes for adults with spinal cord injury. This the first video-based physical activity telerehabilitation intervention and it is hypothesized that it will have moderate effects on self-determination theory variables, physical activity, life satisfaction, and depression. For more information, please view the study record (ClinicalTrials.gov, 2016b). Feasibility and Effect of a Follow-Up Telerehabilitation Program for Chronic Obstructive Lung Disease versus Standard Follow-Up (2-TELEKOL) â¢ Year Posted: 2018 â¢ Sponsor: University of Aarhus â¢ Disease: Chronic obstructive pulmonary disease (COPD) â¢ Intervention: Behavioral â¢ Phase: Not applicable â¢ Digital Health Technology: Telerehabilitation This study aims to assess and compare the feasibility of a telerehabilitation platform âto standard treatment with respect to exercise capacity, quality of life, and activities of daily living in patients with COPD.â For more information, please view the study record (ClinicalTrials.gov, 2018e). âRecovery 4 USââA Photovoice-Based Social Media Program (Boston University) PREPUBLICATION COPY: UNCORRECTED PROOFS
84 VIRTUAL CLINICAL TRIALS: CHALLENGES AND OPPORTUNITIES â¢ Year Posted: 2017 â¢ Sponsor: Boston University â¢ Disease: Mental illness, social isolation, and loneliness â¢ Intervention: Behavioral â¢ Phase: Not applicable â¢ Digital Health Technology: Social media program This study will evaluate a social media program, âRecovery 4 US,â on its ability to enhance community participation and overall recovery of individuals with psychiatric disabilities. The Recovery 4 US platform includes virtually delivered interventions, such as receipt of a hope- inspiring message paired with a corresponding visual image, in addition to community-oriented events initiated by members of the Recovery 4 US community. For more information, please view the study record (ClinicalTrials.gov, 2017c). Maraviroc to Augment Rehabilitation Outcomes After Stroke â¢ Year Posted: 2017 â¢ Sponsor: University of California, Los Angeles â¢ Disease: Stroke â¢ Intervention: Maravirov versus Placebo â¢ Phase: Phases 2 and 3 â¢ Digital Health Technology: Telemonitoring via mobile devices This study will investigate the effectiveness of Maraviroc (in supplement to usual post-stroke care) and will telemonitor all participants via mobile devices (ClinicalTrials.gov, 2017b). ANNOUNCED PARTNERSHIPS FOR VIRTUAL TRIALS AND PLANNED TRIALS 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 37âs Networked Oriented Research Assistant (NORA). Participants will be provided 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, patientsâ data are sent directly to researchers, who have ready access to 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 âremote trials.â Its partnership plans to âlaunch up to 10 trials, with increasing decentralization over 3 yearsâ (Adams, 2018). Set to begin in late 2018 in the United States, trials will focus on dermatology, neuroscience, and cancer. Novartis will leverage Science 37âs NORA technology to facilitate remote collection of data. Novartis is no stranger to this approach and has used a âvirtual approachâ for cluster headaches, acne, and non-alcoholic steatohepatitis (Adams, 2018; Taylor, 2018). PREPUBLICATION COPY: UNCORRECTED PROOFS
APPENDIX C 85 UCB/Science 37 Partnership UCB has announced a partnership with Science 37 to bring clinical trials into participantsâ homes. UCB plans to use Science 37âs NORA platform to evaluate its NeuproÂ® 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). PREPUBLICATION COPY: UNCORRECTED PROOFS