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Decentralized: The Decentralized Trials & Research Podcast: Daily Summaries Delivered
by Decentralized Trials & Research Alliance (DTRA)
Decentralized: The Decentralized Trials & Research Podcast is brought to you by the Decentralized Trials & Research Alliance (DTRA). We are joined each week by passionate leaders in the DCT & Clinical Research community to share insight and vision into the future of research. The Podcast is a replay of the live Clubhouse conversation on Fridays at 12:00 PM ET. The replay of those episodes will drop every Monday, with additional episodes being posted from the archives of 2021-2022 along the way.
Latest Episodes
The most recent episodes — sign up to get AI-powered summaries of each one.
- Yesterday58 min
Project Loom: Can AI Orchestrate the Future of Clinical Trials?
2026-07-24 In this episode of TGIF-DTRA, hosts Jane Myles, Craig Lipset, and Dr. Amir Kalali are joined by Donna Parker and Christoph Hornick from Duke University's iCubed to explore Project Loom, an initiative testing how agentic AI can support clinical trial operations.The conversation covers where AI excelled, drafting protocols, informed consent forms, IRB submissions, and case report forms, and where it struggled, including participant pre-screening. The guests discuss what these findings mean for the future of clinical research, the critical role of human oversight, and how AI could help make trial design and execution more accessible.The episode also explores cybersecurity, workforce implications, and the growing need for standards to evaluate AI quality and interoperability across clinical research.You can join TGIF-DTRA Sessions live on LinkedIn Live on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.
- Jun 15, 202659 min
TGIF-DTRA: Protocol Simulations
2026-06-12 Hosts Jane Myles and Jean Sposaro were joined by Rachel McGovern (Boehringer Ingelheim) who shared how a simple but powerful “mock trial walkthrough” helped uncover protocol and operational challenges before a clinical trial ever enrolled a patient. By simulating key study visits from both patient and site perspectives, Rachel and her team identified opportunities to reduce burden, improve workflows, and strengthen protocol feasibility.The conversation explores lessons learned from the simulation, the value of incorporating site and patient insights earlier in protocol development, and how operational testing can improve recruitment, study execution, and overall trial success. Rachel also discusses the challenges and opportunities of scaling this approach across organizations and therapeutic areas, making a compelling case for protocol simulations as a best practice in clinical research.You can join TGIF-DTRA Sessions live on LinkedIn Live on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.
- Jun 8, 202612 min
The Digital Evolution of DTRA
2026-05-29 DTRA is entering a new chapter. In this special episode, Craig Lipset, Amir Kalali, and Jane Myles discuss the evolution of DTRA from the Decentralized Trials & Research Alliance to the Digital Trials & Research Alliance. Hear why the change reflects the needs of DTRA's membership, how decentralized research remains a cornerstone of the organization's mission, and what's ahead as DTRA expands its work across AI, digital health technologies, real-world data, and other digital innovations shaping the future of clinical research.You can join TGIF-DTRA Sessions live on LinkedIn Live on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.
- Apr 13, 202657 min
Recruitment: The more things change, the more they stay the same?
2026-04-10 Hosts Amir Kalali, Craig Lipset, and Jane Myles were joined by Paul Ivsin (First Patient In) for a discussion about the realities of clinical trial patient recruitment.The conversation explored the disconnect between centralized recruitment success and site-level performance, challenged common industry myths, and highlighted the gap between enrollment projections and real-world results. Paul also shared perspectives on study branding, the limits of recruitment technology and registries, and the role of trust in patient participation.We also discussed strategies for engaging underrepresented physicians and improving access to clinical research.You can join TGIF-DTRA Sessions live on LinkedIn Live on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.
- Mar 23, 20261h 0m
Building Bridges: How One Team Is Connecting Innovation to Practice
2026-03-20 Hosts Dr. Amir Kalali, Jane Myles, and Jean Stimola-Sposaro were joined by Patrick Lee and Dr. Suna Avcil from Amgen’s Digital Medicine team. They shared how they are bridging innovation and real-world practice across their organization. They discuss launching decentralized clinical trials (DCTs), including a hands-on workshop with 50+ medical colleagues, and their approach to change management, starting with open-minded teams, securing leadership support, and using real-world examples to drive adoption. The conversation highlights the importance of starting small, maintaining momentum, and enabling success through clear communication, accessible resources, and collaboration with partners like DTRA.You can join TGIF-DTRA Sessions live on LinkedIn Live on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.
- Feb 23, 202657 min
Selective Safety Data Collection: When "Less" Is Better
2026-02-20 Hosts Craig Lipset, Dr. Amir Kalali, and Jane Myles were joined my Meghana Chalaseni, Mary Thanh-Hai, and Mitch Psotka from the FDA.Today’s session focused on Selective Safety Data Collection (SSDC) and how it can streamline clinical trials when a drug’s safety profile is already well-established. Mary Thanh Hai and Mitch Psotka explained that SSDC, formalized through FDA guidance and ICH E19, allows for a planned reduction in low-value safety data while maintaining robust monitoring of serious adverse events and other critical outcomes. The panel addressed common misconceptions, emphasizing that SSDC does not lower safety standards or eliminate oversight, it simply focuses on collecting data that meaningfully informs the risk-benefit profile.Meghana Chalasani also highlighted FDA’s C3TI demonstration program and other innovative approaches like Bayesian methods and streamlined trials embedded in clinical practice. The discussion closed with practical site-level considerations, including how to integrate SSDC into existing workflows while maintaining consistency and regulatory alignment. Overall, the conversation underscored a shift toward smarter, more efficient trial design without compromising patient safety.You can join TGIF-DTRA Sessions live on LinkedIn Live on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.
- Dec 8, 202558 min
Pioneering DCTs - A Community Approach
2025-12-05 Hosts Dr. Amir Kalali, Craig Lipset, and Jane Myles were joined by Noelle Gaskill and Karla Polk from Tempus AI to unpack how DCTs are expanding access and accelerating research, especially in oncology. They explored how Tempus’ data-connected site network, genomics capabilities, and operational model help match patients faster, streamline startup timelines, and support community practices in running complex trials.The conversation covers real-world strategies for patient activation, managing variability across sites, partnering with CROs, and enabling rural and community-based providers to participate in research. They also touched on the future: global expansion plans and how DCT approaches could extend beyond oncology into other therapeutic areas.You can join TGIF-DTRA Sessions live on LinkedIn Live on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.
- Nov 17, 202556 min
Why People Stay (Or Don't)/ Rethinking Participation in Modern Trials
2025-11-14 - Hosts Amir Kalali and Jane Myles were joined by Alex Charge (ISPEP) and Stacey Davidson (Cuttsy+Cuttsy) on what today’s clinical trial participants experience from start to finish. Drawing on new research conducted by their organizations, the conversation unpacks how patients discover trials, why they join, and what drives both positive experiences and early dropout. Key themes include the importance of strong site support, clearer communication, caregiver involvement, and the operational challenges that trial sites face.The group also explores broader issues in patient engagement—from protocol design and long-term communication gaps to the role AI could play in improving support and retention. The Participation Equation: a webinar from Cuttsy+Cuttsy and ISPEPLink to sign up for the webinar on 11/19 at 9:00 AM ETThe participation equation: Understanding what drives participant engagement in clinical trialsLink to access the report hereYou can join TGIF-DTRA Sessions live on LinkedIn Live on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.
About Decentralized: The Decentralized Trials & Research Podcast
Decentralized: The Decentralized Trials & Research Podcast is brought to you by the Decentralized Trials & Research Alliance (DTRA). We are joined each week by passionate leaders in the DCT & Clinical Research community to share insight and vision into the future of research. The Podcast is a replay of the live Clubhouse conversation on Fridays at 12:00 PM ET. The replay of those episodes will drop every Monday, with additional episodes being posted from the archives of 2021-2022 along the way.
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