Virtual Clinical Trials Challenges and Opportunities: Proceedings of a Workshop (2019) / Chapter Skim
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1 Introduction
1 Introduction
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. Narrow eligibility criteria for participation in clinical trials also creates an issue in that studies may not fully reflect the patient population for which a new therapeutic is intended to treat (i.e., patients in the real world who may receive a specific therapeutic intervention are generally more diverse than study participant cohorts when it comes to age, gender, race, ethnicity, disease severity, or comorbidities)
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Researchers and providers can use information collected through digital health technologies to enhance monitoring and improve understanding of treatment effects and disease progression. Despite the benefits, virtual clinical trials also come with risks, as described by workshop participants: • Patient privacy concerns, such as the risk of sharing sensitive health information over the Internet, said Deven McGraw from Ciitizen Corporation; • Operational challenges, such as the lack of community and pro vider engagement, said Craig Lipset from Pfizer Inc.
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The following workshop sessions aimed to advance discussions and common knowledge among key stakeholders about opportunities for a modern, patient-centric clinical trials enterprise in light of digital health technologies that could enable virtual clinical trials for new medical product approval (see Box 1-1 for the workshop Statement of Task)
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Subject-matter experts will be invited to participate in the workshop through presentations and discussions that will: • Highlight opportunities for systemic improvement to support virtual clinical trials, including o Potential implications of virtual trials for cost, speed, regulation, and knowledge generation and dissemination of clinical trials; and o Elements of an information technology infrastructure, including inte grating data from electronic health records, mobile health applications, remote monitoring, virtual visits, and other relevant technologies with the capability to enhance the interface between clinicians and clinical trial participants. • Explore potential opportunities to use digital health tools to engage with patients and potential research participants, facilitate recruitment of par ticipants to join a clinical trial, and maintain participation of diverse popu lations in the trial: o Collaborative approaches and incentives involving sponsors, re searchers, patient advocacy groups, patients living with the particular condition being studied, and health systems -- including regulations, quality measures and outcomes, or reimbursement strategies -- to support the implementation of virtual clinical trials; and o Opportunities and challenges to enhancing equity in access and par ticipation through virtual clinical trials.
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Chapter 2 summarizes workshop presentations and discussions regarding the inefficiencies of the current clinical trial enterprise, the boundaries of what might be considered a virtual clinical trial for medical product development, the opportunities to expand access for patients, and regulatory questions regarding the remote collection of endpoints. Chapter 3 explores perspectives and experiences with digital health technologies in interventional and observational studies, as well as in clinical care -- highlighting the impact on participant recruitment, engagement, and input on research and study design.
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