DTRA Download: The Digital Trials & Research Podcast

Episodes

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  Clinical Trials Beyond Walls: Building Choice Into Clinical Research 21.09.2026 51m

  2026-09-11 Hosts Craig Lipset and Jane Myles were joined by Becky Kottschade and Dr. Tufia Haddad from the Mayo Clinic to share the evolution of Clinical Trials Beyond Walls, Mayo Clinic’s program for bringing digital and decentralized capabilities into clinical research.Building on Mayo’s experience with remote patient monitoring, the team started by centralizing capabilities, establishing best practices, and testing new approaches in investigator-initiated trials before scaling more broadly. They discuss the importance of giving participants options for how and where they engage in a trial, what they’ve learned about reaching patients beyond traditional geographic boundaries, and the unexpected growth in participation from rural communities.The conversation also explores how Mayo is making these capabilities part of its standard trial approach, the challenge of measuring decentralization across studies, and what comes next—including expanding opportunities to involve local healthcare providers in research.Read their recent publication here -- https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2849940Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.
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  Reflections from the Life Science Technology Forum in China: Scale, Speed, and Ambition 31.08.2026 53m

  Our hosts, Dr. Amir Kalali, Craig Lipset, and Jane Myles were joined by Owen Muir (Radial) to share insights from Beijing from the Life Sciences Technology Forum earlier this year. Notes on what they saw, heard, and learned about the rapidly evolving life sciences landscape in China were shared.The conversation explores the speed and scale of technology adoption, China's growing sophistication in drug development and clinical research, and some eye-opening examples from neuromodulation and healthcare delivery. They also discuss what it takes to conduct global trials across markets, where the U.S. and China approach innovation differently, and why collaboration on shared challenges may be just as important as competition.Their takeaway: China is increasingly important to the future of global drug development—and understanding what's happening there firsthand matters.Follow the Digital Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.
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  Project Loom: Can AI Orchestrate the Future of Clinical Trials? 28.07.2026 58m

  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.
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  TGIF-DTRA: Protocol Simulations 15.06.2026 59m

  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.
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  The Digital Evolution of DTRA 08.06.2026 12m

  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.
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  Recruitment: The more things change, the more they stay the same? 13.04.2026 57m

  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.
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  Building Bridges: How One Team Is Connecting Innovation to Practice 23.03.2026 1h

  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.
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  Selective Safety Data Collection: When "Less" Is Better 23.02.2026 57m

  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.
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  Pioneering DCTs - A Community Approach 08.12.2025 58m

  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.
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  Why People Stay (Or Don't)/ Rethinking Participation in Modern Trials 17.11.2025 56m

  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.
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  AI, Apps and Audits: The new Compliance Chaos in Clinical Research 27.10.2025 52m

  2025-10-24 Hosts Amir Kalali, Craig Lipset, and Jane Myles were joined by Darshan Kulkarni, a pharmacist, lawyer, and educator, for a fantastic conversation around the intersection of healthcare innovation, regulatory law, and emerging technologies. Listeners will learn more on:Challenges in AI protocol protection and data privacy under HIPAA, GDPR, and global lawsThe tension between innovation and compliance in decentralized trialsThe importance of clear regulatory guidance in the evolving AI landscapeHow contractual and ethical frameworks can safeguard both sponsors and sitesYou 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.
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  Transcelerate's Sponsor Considerations for Obtaining Site Feedback 06.10.2025 56m

  2025-10-03 Hosts Amir Kalali, Craig Lipset, and Jane Myles were joined by representatives from TransCelerate BioPharma Inc.’s Modernizing Clinical Trial Conduct initiative for our discussion. This initiative is helping the industry move beyond pandemic-era adaptations toward lasting transformation. In this session, we highlighted a newly released tool designed to help sponsors collect meaningful site feedback to improve decentralized clinical trial (DCT) implementation. We discussed the importance of patient, site, and sponsor feedback in shaping trial design, and touch on other relevant resources that support more patient-centric, flexible, and resilient approaches. Hear from Laura Renton (GSK) and Anna Christiansson (AstraZeneca) in this practical discussion on these resources and how you can begin to apply them in your organization.Modernizing Clinical Trial Conduct Solutions ToolkitYou 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.
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  Digital Therapeutics in Decentralized Trials 15.09.2025 57m

  2025-09-12 Our hosts Dr. Amir Kalali and Jane Myles were joined by Cinja Nadana Koller and Marc Blanchard, affilated with CHUV | Lausanne university hospital to discuss their joint paper on an assessment of digital therapeutics in DCTs. In this episode, we dove into the intersection of decentralized clinical trials (DCTs) and digital health technologies (DHTs), with a spotlight on rheumatology and beyond. Our guests explored the challenges of patient engagement, onboarding, and adherence, and shared lessons learned from real-world implementations of digital tools in trials. We also discussed innovations in patient monitoring for inflammatory arthritis, Switzerland’s approach to scaling digital health, and opportunities for collaboration across healthcare systems.Link to Paper -- https://journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000905You 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.
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  Home visits for Rare Disease Research 25.08.2025 59m

  2025-08-22 Hosts Craig Lipset and Jane Myles hosted a conversation with Alpa Kushillani, VP of Customer Success & Delivery with Gooseberry Research and a rare disease advocate. Alpa shares her family’s journey with Duchenne muscular dystrophy and how those experiences inspired her to create new solutions for patient-centered research.We explore the realities of clinical trial participation for rare disease families—from challenges in home healthcare and nurse training to the promise of digital health tools and decentralized approaches. Alpa highlights how Gooseberry Research is working to improve trial accessibility through specialized nurse training, stronger site communication, and partnerships with technology providers.The episode also touches on trial design hurdles, the need for meaningful endpoints, and the future of decentralized clinical trials. Episode Resources:DCT Market TrendResearch About a Novel, Home-Based Assessment for Duchenne Muscular DystrophyYou 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.
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  A Pathway to use Site-Selected Technology in Clinical Trials 04.08.2025 56m

  2025-08-01 Hosts Dr. Amir Kalali and Jane Myles discussied DTRA's Bring Your Own Technology initiative with leaders Brandon Maggio (GSK) and Joe Dustin (Dauntless eClinical Strategies).Sites are managing 20+ systems per trial, leading to fatigue and friction. DTRA’s BYOT (Bring Your Own Technology) initiative aims to empower sites to use their own validated tools like eConsent and eSource. Hear how this approach streamlines workflows, improves data quality, and puts sites and patients first.BYOT Playbook -- https://www.dtra.org/bring-your-own-technology
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  Including HCPs in Clinical Trials 22.07.2025 59m

  2025-07-18 Hosts Craig Lipset, Jane Myles, and Dr. Amir Kalali were joined by Shelly Barnes (UCB), Brittany Niland (Eli Lilly and Company) and Erica Coles Jacobsen (Konovo) for a discussion around healthcare providers (HCPs) and their involvement in clinical research. DTRA has partnered with Eli Lilly and Company and Konovo to better understand the sentiment of these HCPs around participating in clinical research. Using HCPs in trials can provide greater access for all patients, as well as continuing to build trust in research with providers. You can join TGIF-DTRA Sessions 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.
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  DIA Roundup 30.06.2025 1h 1m

  2025-06-27 Hosts Craig Lipset and Jane Myles shared about all things DIA Global Annual Meeting 2025. They shared more about key discussions and themes seen on the stage and in sessions and shared insights from attending the event this year. Additionally, Jane Myles shared more about her panel discussion on HCPs participating in 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.
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  The Power of Site Networks in Innovation 16.06.2025 56m

  2025-06-16 Hosts Craig Lipset, Dr. Amir Kalali, and Jane Myles held a conversation with Jim Kremidas (Association of MultiSite Research Corporations) to share more about his personal journey as a clinical trials patient, his career in clinical research, and his work now with AMRC around innovation for sites.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.
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  Trial By Experience: Living both sides of Clinical Research 19.05.2025 58m

  2025-05-16 In honor of Clinical Trials Day (May 20), we look forward to featuring individuals who’ve not only worked behind the scenes in clinical research but have also stepped into the role of participant. Join us to hear how their personal experiences reshaped their professional perspectives, deepened their empathy, and changed how they think about the future of trials through their learned experiences. Our hosts Craig Lipset and Jane Myles were joined by Alicia Staley, Craig Serra, and Terttu Haring to share their experiences.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.
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  From Idea to Digital Measurement via DCT 09.05.2025 56m

  2022-06-10 Hosts Craig Lipset and Amir Kalali were joined by Francesca Rinaldo (prev. Sharecare, now SCAN) and Emily Lewis (UCB) around opportunities to impact myasthenia gravis patients and researchers with better digital measurements on a smartphone.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.