Affiliations: [a] Department of Neurology, University of Rochester, Rochester, NY, USA
| [b] Center for Health+Technology, University of Rochester, Rochester, NY | [c] Department of Neurology, University at Buffalo, Buffalo, NY, USA
University of Michigan Medical School, Ann Arbor, MI, USA
| [e] AMC Health, New York, NY, USA
| [f] Early Phase Clinical Development, Eli Lilly and Company, Indianapolis, IN, USA
| [g] Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
Correspondence to: Christopher G. Tarolli, MD, MS, 601 Elmwood Ave, Box MIND, Rochester, NY 14642, USA. Tel.: +1585 275 2427; Fax: +1 585 756 5189; E-mail: [email protected].
Abstract: Background:There is rising interest in remote clinical trial assessments, particularly in the setting of the COVID-19 pandemic. Objective:To demonstrate the feasibility, reliability, and value of remote visits in a phase III clinical trial of individuals with Parkinson’s disease. Methods:We invited individuals with Parkinson’s disease enrolled in a phase III clinical trial (STEADY-PD III) to enroll in a sub-study of remote video-based visits. Participants completed three remote visits over one year within four weeks of an in-person visit and completed assessments performed during the remote visit. We evaluated the ability to complete scheduled assessments remotely; agreement between remote and in-person outcome measures; and opinions of remote visits. Results:We enrolled 40 participants (mean (SD) age 64.3 (10.4), 29% women), and 38 (95%) completed all remote visits. There was excellent correlation (ICC 0.81–0.87) between remote and in-person patient-reported outcomes, and moderate correlation (ICC 0.43–0.51) between remote and in-person motor assessments. On average, remote visits took around one quarter of the time of in-person visits (54 vs 190 minutes). Nearly all participants liked remote visits, and three-quarters said they would be more likely to participate in future trials if some visits could be conducted remotely. Conclusion:Remote visits are feasible and reliable in a phase III clinical trial of individuals with early, untreated Parkinson’s disease. These visits are shorter, reduce participant burden, and enable safe conduct of research visits, which is especially important in the COVID-19 pandemic.