DTRA Download: The Digital Trials & Research Podcast

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/2849940

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.

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.

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.

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.

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.

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.

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.

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.

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.

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 ISPEP

• Link to sign up for the webinar on 11/19 at 9:00 AM ET

The participation equation: Understanding what drives participant engagement in clinical trials

• Link to access the report here

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.