Decentralized: The Decentralized Trials & Research Podcast
by Decentralized Trials & Research Alliance (DTRA)
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Recent episodes
Recruitment: The more things change, the more they stay the same?
Apr 13, 2026
Unknown duration
Building Bridges: How One Team Is Connecting Innovation to Practice
Mar 23, 2026
Unknown duration
Selective Safety Data Collection: When "Less" Is Better
Feb 23, 2026
Unknown duration
Pioneering DCTs - A Community Approach
Dec 8, 2025
Unknown duration
Why People Stay (Or Don't)/ Rethinking Participation in Modern Trials
Nov 17, 2025
Unknown duration
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| Date | Episode | Description | Length | ||||||
|---|---|---|---|---|---|---|---|---|---|
| 4/13/26 | 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. | — | ||||||
| 3/23/26 | 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. | — | ||||||
| 2/23/26 | 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. | — | ||||||
| 12/8/25 | 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. | — | ||||||
| 11/17/25 | 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. | — | ||||||
| 10/27/25 | AI, Apps and Audits: The new Compliance Chaos in Clinical Research | 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. | — | ||||||
| 10/6/25 | Transcelerate's Sponsor Considerations for Obtaining Site Feedback | 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. | — | ||||||
| 9/15/25 | Digital Therapeutics in Decentralized Trials | 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. | — | ||||||
| 8/25/25 | Home visits for Rare Disease Research | 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. | — | ||||||
| 8/4/25 | A Pathway to use Site-Selected Technology in Clinical Trials | 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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| 7/22/25 | Including HCPs in Clinical Trials | 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. | — | ||||||
| 6/30/25 | DIA Roundup | 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. | — | ||||||
| 6/16/25 | The Power of Site Networks in Innovation | 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. | — | ||||||
| 5/19/25 | Trial By Experience: Living both sides of Clinical Research | 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. | — | ||||||
| 5/9/25 | From Idea to Digital Measurement via DCT | 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. | — | ||||||
| 4/28/25 | Navigating US Regulatory Change in an unpredictable environment | 2025-04-25 Hosts Craig Lipset and Jane Myles were joined by Greg Dombal and Laura DiAngelo (Agency IQ) to discuss the rapidly changing regulatory environment in the US, particularly in the clinical research sector, and its implications for those operating in this highly regulated space. The participants discussed the impact of recent changes such as reductions in force and reorganizations on the industry, and the evolving policies at the FDA, including the concept of an intermediate clinical endpoint and the interpretation and mapping of these concepts. The team also discussed the potential changes in the FDA's organizational structure, its impact on the agency's role in international collaborations, and the need for a balance between safety and efficacy in drug development.Resources:Subscribe to AgencyIQs FDA Today Newsletter hereMegyn Kelly Show with Dr. Martin Makary, new FDA CommissionerYou 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. | — | ||||||
| 4/14/25 | Navigating the ICH E6 R3 with tools & solutions | 2025-04-11 Hosts Craig Lipset and Jane Myles were joined by our partners TransCelerate BioPharma Inc. and ACRO for a discussion on their tools & solutions that were developed to better understand the ICH E6 R3. We welcomed Christine Goffe (UCB), Paul Slagle (IQVIA), and Hasnaa Likaoui (BMS) to share about the data lifecycle framework tool and the trial design considerations tool that they have worked on to help better support trial planning and design.The tools can be found online at the following websites:Transcelerate ICH E6 Asset Library -- https://www.transceleratebiopharmainc.com/assets/ich-e6-asset-library/Transcelerate ICH E6 R3 Tools & Resources Webinar -- https://www.youtube.com/watch?v=W-6vM6hOLcU&feature=youtu.beACRO Interpreting ICH E6 R3 -- https://www.acrohealth.org/initiatives-hub/interpreting-ich-e6r3/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. | — | ||||||
| 4/7/25 | Bringing Community Oncologists into Trials | 2025-04-04 Hosts Craig Lipset and Jane Myles were joined by Kaitlin Morrison from UNC Lineberger Comprehensive Cancer Center. She shared her experiences with the potential of decentralized clinical trials, particularly in oncology, to expand participation beyond academic medical centers. We discussed the challenges of conducting clinical trials, the importance of trust and information sharing in building partnerships with local healthcare providers, and the potential benefits of working with these providers.Episode Resources:Conducting Clinical Trials With Decentralized ElementsIntegrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical PracticeYou 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 to see what sessions are coming next and get the link to join. Learn more about Membership options and our work at www.dtra.org. | — | ||||||
| 3/21/25 | Patient Experience Ratings & Decentralized Trials | 2022-03-18 Host Craig Lipset was joined by Irfan Khan (Circuit Clinical), Kelly McKee (Evinova), and Kerry Hicks (HW Investment Partners) for a conversation around the application of patient experience in clinical research, health ratings for providers, and more.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. | — | ||||||
| 3/7/25 | A Patient Perspective on the DCT Field | 2022-03-11 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Stacy Hurt (Parexel) for an insightful discussion around the perspective of a patient on the DCT field.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. | — | ||||||
| 3/3/25 | Breaking Barriers in Tech Adoption & AI | 2025-02-28 We welcomed Mike Wenger (FullStack Trials) and Melissa Holbrook (Clinical Research Advisory Group LLC) for a discussion around the biggest challenges in clinical trial technology adoption. We dived into getting feedback from sites, finding new ways to navigate using AI, and moreYou 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. | — | ||||||
| 2/10/25 | SCOPE Summit 2025 Recap | 2025-02-07 Hosts Craig Lipset & Jane Myles took the stage to share their thoughts around the SCOPE Summit that was held earlier this week in Orlando, FL. They covered high level findings and thoughts on the environment for 2025 and a download on a few panels they were moderated by the DTRA team.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. | — | ||||||
| 2/3/25 | From Chaos to Clarity: Defining Who Does What? | 2025-01-31 Hosts Jane Myles (DTRA) and Michelle Shogren (Innovate In What You Do!) were joined by Rebecca Kottschade (Mayo Clinic) and Caroline Redeker (Advanced Clinical) to share about the work they led at DTRA around Roles and Responsibilities when using decentralized elements in clinical trials.Sites are overburdened with technology and role ambiguity as the use of DCT methods in clinical trials evolve. It is often unclear to sites whose responsibility it is to do what when using DCT methods. Site considerations for implementation of DCTs include training, ongoing support, cost, risk, responsibility, logistics, integrations, and teaching patients how to use and enable the DCT offerings. This team developed a set of questions to be applied before site selection and at site activation to aid in study planning.The newly released work is now available on the DTRA website at: https://www.dtra.org/roles-and-responsibilities-colabYou 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. | — | ||||||
| 1/30/25 | Demystifying eConsent - The European Forum GCP eConsent Suite of Tools | 2025-01-29 Hosts Craig Lipset and Jane Myles hosted a great discussion with Hilde Vanaken (EFGCP - European Forum for Good Clinical Practice) and Katrin Ong (Boehringer Ingelheim) to share about the suite of tools created by the European Forum for Good Clinical Practice's eConsent initiative and how they can be used to demystify eConsent.There are many resources available for use. Review the resources, tools, articles, and more here --> https://efgcp.eu/project?initiative=eConsentYou 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. | — | ||||||
| 1/20/25 | What is needed for HCs to support routine care in clinical trials? | 2025-01-17 Irfan Khan, MD (Circuit Clinical) joined hosts Craig Lipset and Jane Myles for a discussion around what HCPs think about clinical research and how to gain their support on routine care in clinical trials. We discuss the journey of HCPs becoming investigators and what we need to drive this forward in the community.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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