Envisioning a Transformed Clinical Trials Enterprise for 2030 Proceedings of a Workshop (2022) / Chapter Skim
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4 Practical Applications for Technology to Enhance the Clinical Trials Enterprise
4 Practical Applications for Technology to Enhance the Clinical Trials Enterprise
Pages 35-48
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From page 35... ...
(Chang) • Data are needed to characterize the performance of technol ogy-enabled, decentralized clinical trials based on parameters such as participant safety, participant and site experience, data privacy, and data integrity.
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Participants considered ways that thoughtful and deliberate use of digital technologies could support the goals of improving person-centeredness and inclusivity of clinical trials and ensuring resilience, sustainability, and transparency in the clinical trials enterprise. THE ROAD TO 2030: PERSPECTIVES FROM THE FIELD Frontline Experience: A Panel Discussion In this session, three panelists described how they are working to apply technology practically in pursuit of an improved clinical trials enterprise.
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This means it is important to find ways to be inclusive and to connect with those in the community who may not have wireless Internet access or the ability to use it, for example. Bidirectional Information Flow Hastings pointed out that technology is "a two-way street." It is not just about what trial participants may contribute to research, but also what the clinical trials enterprise can give back to participants and their providers that could better inform their own health care and choices.
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Solutions must correctly follow data privacy and security regulations to protect patient information and the integrity of trial data. What is needed, Hirsch said, is agreement among regulatory agencies on what policies and oversight are necessary to govern and coordinate use of digital health technologies in clinical trials, such that relevant policies are streamlined and more easily understood by developers working in different areas.
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. Hastings emphasized the need for co-development of clinical trial technologies with the people the products are intended to serve.
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Pamela Tenaerts, chief scientific officer at Medable and former executive director at CTTI, discussed implementing technology to enable decentralized clinical trials in a responsible way. The session was moderated by Anita Allen, professor of law and philosophy at the University of Pennsylvania Carey Law School.
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She added that it is critical to ensure that data integrity and privacy are not compromised when implementing new tools and technologies for data collection. She referred participants to the TransCelerate website for information on these and other resources, including a paper sharing best practices and assessing how the lessons learned from the COVID-19 response could inform modernization of the clinical trials enterprise after the pandemic.5 Stakeholders in the clinical trials ecosystem now have an opportunity to create lasting change by shifting to a collaborative mindset, she said.
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Several individual workshop participants, including Robert Califf of V erily Life Sciences (see Chapter 2) and breakout participants summarized in Chapter 3, emphasized that the practical application of digital health tech nologies can improve access to clinical trials for participants who may not live near traditional brick-and-mortar clinical trial sites.
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Tenaerts pointed out that the use of technology can potentially improve the data collection process, but without caution and careful monitoring can also introduce systematic bias or error. Data are also needed that demonstrate how conducting technology-enabled decentralized trials leads to a better trial experience for both participants and sites, and enhances trust in the clinical trials enterprise.
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In doing so, Goldsack explained, "we are able to deliver to the target user a product that is inherently valuable and inherently appealing." Long-Term Goals for Applying Technology to Improve Trial Diversity and Inclusivity: Panel and Breakout Discussion Highlights In this breakout session, groups focused on the role of technology in achieving the goal of establishing a clinical trials enterprise that is more diverse, equitable, and inclusive, and the goal of establishing a national network of community-based clinical trial sites. Participants discussed practical applications of technologies, barriers to implementation and use,
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REFLECTIONS ON REALIZING THE POTENTIAL OF TECHNOLOGY IN CLINICAL TRIALS Andy Coravos, co-founder and CEO of Elektra Labs (renamed HumanFirst since the time of the workshop) ; Eric Perakslis, chief science and digital officer at the Duke Clinical Research Institute; and Sam Roosz, cofounder and CEO of Crescendo Health reflected on realizing the vision of a transformed clinical trials enterprise through the thoughtful and responsible deployment of technologies.
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Patients should be able to trust that their information is secure 8 Coravos also referred participants to The Playbook, a guide for developing and deploying digital clinical measures in clinical trials, health care, and public health developed by the Digital Medicine Society. See https://playbook.dimesociety.org (accessed July 1, 2021)
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He advocated for considering how providers could better use patient care interactions as opportunities to engage people in clinical research, and using technologies to make the integration more seamless for patients and providers. Potential Next-Step Actions for Stakeholders Krofah asked panelists to suggest next-step actions by stakeholders in the clinical trials enterprise to begin implementing technologies toward their vision for 2030 now.
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Roosz emphasized that the problems with integrating and scaling new technologies in clinical trials do not need to be solved all at once. He encouraged those who are conducting studies to choose one or several new methodologies, use them, and solicit feedback from stakeholders on how they impacted the conduct of the trial and the patient experience.
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