Virtual Clinical Trials Challenges and Opportunities: Proceedings of a Workshop (2019) / Chapter Skim
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2 Opportunities to Improve Clinical Trials
2 Opportunities to Improve Clinical Trials
Pages 7-18
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• Virtual clinical trials can be used to improve the comfort, convenience, and confidentiality for research participants com pared with what they might receive in a more traditional site based clinical trial. (Dorsey)
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of the Global Liver Institute, offered a patient perspective on considerations necessary for designing clinical trials to meet the needs of trial participants. Craig Lipset, head of clinical innovation within global product development at Pfizer Inc., provided an industry perspective on the potential for virtual clinical trials to improve the efficiency of Phase 3 clinical research.
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Cryer drew attention to the limited protocol flexibility of clinical trials, which often excludes large groups of patients from trials. Novel data mining techniques can shed light on which patient populations should be included in clinical trials, lead to more realistic inclusion/exclusion criteria, and result in better participant recruitment and retention.
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According to Lipset, the REMOTE trial did not operate at the available limit of technology when it was conducted in 2010, nor did it require any new legislation, safe harbor, or guidance from regulators. As a result, new regulatory or technical frameworks may not be necessary to successfully launch virtual trials.
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Additionally, it is likely, Lipset noted, that cost savings from virtual trials would occur in the long term. AN ACADEMIC PERSPECTIVE Ray Dorsey, Director, Center for Health and Technology, University of Rochester Current Model for Clinical Trials Clinical trials as currently conducted are expensive, inefficient, and inaccessible.
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New Models for Clinical Trials The pharmaceutical industry has already begun to leverage emerging digital health technologies to make clinical research accessible, convenient, and less costly. For example, Pfizer's REMOTE study conducted all aspects of the clinical trial remotely via Web-based approaches (ClinicalTrials.gov, 2013; Orri et al., 2014)
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However, Dorsey continued, there are likely to be more clinical trials that incorporate both traditional and decentralized models. Examples of Virtual Clinical Trials Dorsey provided three examples that illustrate how virtual trials can increase participant access and geographic representation, improve the participant experience, and enhance recruitment for patient subpopulations: (1)
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Parkinson's disease is typically visually diagnosed. The virtual platform used in the study allowed investigators to visually examine Parkinson's disease status remotely via videoconferencing, without requiring participants to leave their homes.
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; perhaps most importantly, they enable studies to be more participant centered. The geographic reach of a virtual trial, Dorsey noted, will not be determined by where someone lives, but by whether they have Internet access.
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Dorsey envisions that virtual trials could reduce costs in the long term. While the tools to conduct virtual trials already exist, the main barriers preventing industry from applying these tools may be creativity and will, which Dorsey hopes can be increased and galvanized.
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Nitin Desai, chief medical officer at Health Wizz, asked the speakers to comment on any legal or ethical barriers that may prevent engagement with potential trial participants. Lipset acknowledged this issue, but noted that a more significant upstream challenge is the lack of awareness by treating physicians about trials in which their patients could be enrolled.
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Emily Butler, a statistician from GlaxoSmithKline, commented that a not-insignificant proportion of data collected during a clinical trial is not examined, and asked the speakers if there should be a balance between optimal data collection upfront and collecting data that are valuable. According to Dorsey, overemphasizing data collection is not necessarily a bad thing, citing examples of medical discoveries such as nocturnal hyperglycemia and sleep disorders, which resulted from more intensive measurements.
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