Decentralized: The Decentralized Trials & Research Podcast

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

2024-12-20 Hosts Amir Kalali, Craig Lipset, and Jane Myles came together for the final TGIF-DTRA of the year, 2024 in Review! We shared more about what we did in 2024 at DTRA, what has been happening in the ecosystem, and some predictions for 2025!You can join TGIF-DTRA Sessions live on LinkedIn Live Audio 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.

2024-12-06 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Anna Yang and Elizabeth Mandel (Genentech) joined us for a discussion around defining, measuring, and benchmarking data quality with 2 ongoing hybrid studies.You can join TGIF-DTRA Sessions live on LinkedIn Live Audio 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.