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00:00:00 – 00:26:39
The video discusses the evolution of clinical trials towards decentralized approaches and the utilization of real-world data for personalized healthcare advancements. Key themes include leveraging real-world evidence, investing in software for data collection, addressing diversity issues in clinical trials, and ensuring participant safety while improving data quality. The importance of policy changes, investments, and regulatory considerations in advancing healthcare innovations is emphasized. The discussion also highlights collaborations with various stakeholders and the focus on inclusive and efficient research practices, particularly in light of the COVID-19 pandemic. Overall, the video emphasizes the shift towards more inclusive, efficient, and personalized clinical research practices with a focus on leveraging technology, real-world data, and continuous evidence generation.
00:00:00
In this segment of the video, Jessica Domason interviews Amy Abernethy, former FDA deputy commissioner and current president of Verily’s clinical studies platforms. Amy discusses her recent testimony to Congress focusing on personalized healthcare and clinical trials advancements. She highlights topics such as virtual and decentralized clinical trials, diversity in trial participation, leveraging sensors for data collection, and evaluating medical products like software as medical devices. Amy emphasizes the importance of investments and policy changes to advance personalized healthcare. Additionally, she shares insights into the sentiment and reception from Congress regarding these healthcare innovations and regulatory changes.
00:03:00
In this segment of the video, the speaker discusses the importance of the 21st Century Cures Act, passed in December 2016, which paved the way for leveraging real-world data to address diversity issues in clinical trials. The speaker highlights the significance of decentralized capabilities, new trial designs, and investments in software for patient-reported information collection. They mention the evolution of this legislation with Cures 2.0, emphasizing increased investment in decentralized trial capabilities, interoperability, and patient-reported outcomes. The discussion also delves into the need for more inclusive and accessible clinical trials, incorporating real-world data and virtual components to address health equity concerns. The speaker stresses the importance of meeting participants where they are, reducing data collection burden, and improving operational aspects of clinical trials to ensure more representative and efficient research practices.
00:06:00
In this segment of the video, the discussion centers around decentralized clinical trials and the importance of generating high-quality data while ensuring participant safety. The shift towards decentralized trials has challenges in terms of safety and data quality, which the FDA emphasizes. The concept of “omni-channel” clinical trials, incorporating in-person and virtual components, is highlighted as an emerging trend. Real world evidence, defined as data collected outside traditional clinical trials, is discussed in the context of its growing significance and regulatory considerations, particularly in the development and approval of vaccines. The conversation points towards the evolving landscape of clinical trials and the need to ensure data integrity and participant safety moving forward.
00:09:00
In this part of the video, the speaker discusses the concept of real-world evidence and data, which are generated outside traditional clinical trial settings and can include data from electronic health records, claims data, sensors, and prospective registries. Real-world evidence is derived from the analysis of real-world data and is often more generalizable and representative of larger populations. However, challenges include lower data quality and missing data points. The speaker highlights advancements in health tech and data innovation that have led to improved credibility in leveraging real-world data for evidence. They mention the FDA’s development of a framework for considering real-world evidence in regulatory decisions and recent draft guidances providing details on data quality and generation. The speaker encourages audience members to provide feedback for finalizing the guidance, which aims to provide a blueprint for leveraging real-world data for various research questions, including high-risk regulatory ones.
00:12:00
In this segment of the video, it is discussed how new capabilities in data and health tech have led to the realization of leveraging real-world data, particularly in light of the impact of Covid-19. Real-world data from sources like Israel have been crucial in understanding vaccine effectiveness and the need for boosters. There is a growing trend towards combining traditional clinical trial data with real-world data to gain a broader understanding of medical product performance over its entire lifecycle. The value of real-world data and evidence is highlighted in three key categories: aiding in clinical trial planning, enabling scientific discovery, informing post-market product performance, and potentially replacing control arms in trials.
00:15:00
In this segment of the video, the speaker discusses the importance of continuous assessment of AI-enabled devices over time, including post-approval evaluations. They emphasize the shift towards continuous evidence generation using real-world data and real-world evidence, moving away from traditional clinical trial structures. The speaker suggests that this evolution in evidence generation by the FDA, including leveraging real-world data, is likely to continue post-COVID due to its effectiveness in evaluating devices and products efficiently for unmet medical needs.
00:18:00
In this segment of the video, the speaker discusses the increasing need for personalized information, particularly in terms of identifying missed populations in clinical trials and exploring combined treatments. The pace is expected to shift towards more evaluation in the post-approval setting. The conversation then shifts to Verily, where the guest, Amy, is heavily involved in evolving the clinical research program. The focus is on utilizing software and technology to conduct clinical trials more efficiently and inclusively, aiming to reach all populations and generate continuous evidence while reducing participant burden. The team at Verily is planning to advance these goals in 2022.
00:21:00
In this segment of the video, the speaker discusses their focus on building solutions for daily life activities, such as electronic consenting and patient outcome reports. They are also emphasizing the development of longitudinal data sets by combining real-world data with traditional clinical trial data. The third major focus is on digital biomarkers and sensor data collection for movement and physical functioning analysis. Furthermore, they highlight their collaboration with various customers including large pharma, small pharma, device companies, and academic institutions like Duke and Stanford for projects like the HERO Together Registry evaluating the Pfizer vaccine. This registry enables prospective monitoring of vaccine performance and adverse effects over time.
00:24:00
In this segment of the video, the speaker discusses how they are working with large networks of clinical research sites to utilize software to quickly enroll participants, including offering language translations. They mention their focus on building software for research workflows, longitudinal data sets, and partnerships in 2022. The speaker hints at upcoming developments and acquisitions in the business, emphasizing the importance of thorough planning. The host appreciates the detailed insights provided and invites the speaker back for future updates.