Decentralized: The Decentralized Trials & Research Podcast

Decentralized Trials & Research Alliance (DTRA)
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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. You can find this podcast live every Fridays at 12:00 PM EST on Clubhouse at the Decentralized Trials Club (https://www.clubhouse.com/club/decentralized-trials). The Podcast will be a replay of the live Clubhouse conversation on Friday's 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. We encourage you to connect with us on LinkedIn at Decentralized Trials & Research Alliance (DTRA) and on Twitter @DTRAOrg to learn more about the organization.

  1. FEB 23

    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.

    58 min

  2. 12/08/2025

    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.

    58 min

  3. 11/17/2025

    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 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.

    57 min

  4. 10/27/2025

    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 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.

    52 min

  5. 10/06/2025

    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 Toolkit 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.

    57 min

  6. 09/15/2025

    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.0000905 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.

    57 min

  7. 08/25/2025

    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 Trend Research About a Novel, Home-Based Assessment for Duchenne Muscular Dystrophy 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.

    59 min

  8. 08/04/2025

    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

    56 min
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About

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. You can find this podcast live every Fridays at 12:00 PM EST on Clubhouse at the Decentralized Trials Club (https://www.clubhouse.com/club/decentralized-trials). The Podcast will be a replay of the live Clubhouse conversation on Friday's 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. We encourage you to connect with us on LinkedIn at Decentralized Trials & Research Alliance (DTRA) and on Twitter @DTRAOrg to learn more about the organization.

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