Virtual Clinical Trials Challenges and Opportunities: Proceedings of a Workshop (2019) / Chapter Skim
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3 Exploring Virtual Clinical Trials
3 Exploring Virtual Clinical Trials
Pages 19-36
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From page 19... ...
• Virtual clinical trials embedded in a health care system work well when the trial outcome is captured in the electronic health record (EHR) , the health care system partner is interested in the study outcome, the intervention is familiar but being tested for a new indication, and few competing interventions or trials are ongoing in the health care system.
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From page 20... ...
Jenna B ollyky, vice president for clinical research and analytics at Livongo Health, and Joshua Denny, professor of biomedical informatics and medicine at the Vanderbilt University Medical Center, provided lessons learned from clinical care and observational studies, respectively. Insights on lessons learned from interventional virtual clinical trials were presented by Steven Cummings, director of the San Francisco Coordinating Center; Wendy Weber, acting deputy director at the National Institutes of Health's (NIH's)
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From page 21... ...
Livongo has developed a platform, Applied Health Signals,1 which aggregates real-world patient health data from multiple sources, interprets these data using medical literature and clinical insights, applies data to solutions, and iterates until desired patient outcomes are achieved. In addition to the data collected from digital health technologies, Livongo aggregates data on people's health behavior, physical activity, and medical and pharmacy claims, with the aim of helping people lead healthy lives and spend less time worrying about their conditions.
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From page 22... ...
LESSONS LEARNED FROM OBSERVATIONAL STUDIES Joshua Denny, Professor of Biomedical Informatics and Medicine, Vanderbilt University Medical Center All of Us Joshua Denny centered his presentation on cohort research and how it can facilitate clinical trials, using All of Us,3 U.K. Biobank,4 and Project 2 Glycated hemoglobin A1c (HbA1c)
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From page 23... ...
Currently, more than 200 sites enroll participants through health care providers or directly at numerous consumer health sites, such as Walgreens clinics, blood banks, Quest, EMSI,7 and QTC/Leidos.8 To ensure that similar information is collected for all individuals, All of Us uses a common interface for recruitment, a common process for consent (which includes sharing EHR data) , and common modules for health surveys.
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From page 24... ...
. Large, diverse observational study cohorts, Denny continued, stand to accelerate clinical trials by generating basic discoveries, enabling direct and targeted recruitment of diverse populations and facilitating their assessment through existing cohort technology platforms, and enabling more intelligent trial design.
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From page 25... ...
A retrospective mining of clinical trial data indicated that those with a loss of CYP2C19 function were 50 percent more likely to experience a stroke, heart attack, or other cause of death compared with patients with func tional enzyme. This effect size was confirmed in an analysis of electronic health records combined with DNA analysis that showed the same response.
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From page 26... ...
It used a participant-facing electronic data capture system, eConsent (use of multimedia on a digital platform to develop an interactive consent process) , and a quiz to confirm that the participant understood the study (Grady et al., 2017)
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From page 27... ...
approval to ship the investigational product directly to participants' homes, prescribing laws limited recruitment to nine states, some of which required physical examinations by a physician prior to dispensation. Furthermore, during the run-in period, participants were asked to carry a plastic container to measure urine volumes and enter this information into a digital health technology.
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From page 28... ...
Simplicity for the participant is essential, and recruitment from trusted communities and known providers may be more successful than solely Web-based recruitment. Such studies could reach participants in more states if prescribing laws were changed to allow for the shipment of study drugs without requiring physical examinations, said Cummings.
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From page 29... ...
The Collaboratory Coordinating Center assists the trials via working groups21 and releases lessons learned into The Collaboratory's knowledge repository.22 Materials posted include how to design and conduct trials embedded in health systems and disseminate their results for diffusion into learning health systems, noted Weber. Using these lessons learned, The Collaboratory is able to help projects troubleshoot real issues as they arise, such as transitioning from International Statistical Classification of Diseases and Related Health Problems (ICD)
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From page 30... ...
To fill in missing data in a pain study, for example, the project team augments data capture of the Brief Pain Inventory23 by emailing participants a link so they can complete the instrument themselves online. Those participants who did not respond to the email then received an automated call that enables them to enter in their pain scores using their touchtone phones.
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From page 31... ...
Emerging digital health technologies provide an opportunity to design decentralized clinical trials, which she called a disruptive approach to organizing the trial around the patient. In particular, Hawkins noted five opportunities that decentralized trials provide: 1.
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An important concern, however, is endpoint validation using a specific digital health technology, which requires implementing a time to validate the technology into a clinical development plan. Change Management Hawkins indicated that change management is likely the biggest challenge of adopting decentralized clinical trials.
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From page 33... ...
The technical challenges, however, will not be small, he added. Craft shared that when he was working with the innovation group at a large pharmaceutical company to help address the problem of slow, expensive, and burdensome clinical trials, he observed that neither academic medical centers, contract research organizations, nor technology companies were equipped to truly create a D2P clinical trials paradigm.
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From page 34... ...
Proposed rules have been issued from ONC and the Centers for Medicare & Medicaid Services that will lay out the federal government's policy for how it will regulate those health information systems to make the data available through application program interfaces without special effort. White reported that his office is going to work on freeing health data and challenged workshop participants to more actively partner with clinical trial participants -- not least of all because in the future participants will have their data and researchers will need to work directly with participants to study the data.
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From page 35... ...
Bollyky remarked that her company uses two-way digital health technologies to reach out to people and confirm reading accuracy.
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From page 36... ...
Additionally, due to the use of digital health technologies by research staff and participants, it is harder to commit fraud in a virtual clinical trial than in a regular trial. Craft also noted that participants are not required to provide photo identification in a traditional clinical trial, and it is wrong to set the bar higher for D2P trials.
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