Decentralized: The Decentralized Trials & Research Podcast

Decentralized Trials & Research Alliance (DTRA)
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Decentralized: The Decentralized Trials & Research Podcast

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. NOV 4

    Unlocking the Potential of Clinical Trial Data: New CRDSA Standards

    2024-10-31 Clinical Research Data Sharing Alliance (CRDSA) published two new standards earlier this year: the Standard for Sharing Clinical Study Data and the Standard for Secondary Analysis of Clinical Study Data. We held a great discussion on how these standards aim to facilitate the responsible sharing and use of anonymized individual patient data from clinical studies to support the research community and accelerate the discovery and delivery of new therapies to patients. Data Reuse in Regulatory Submissions: The Role of Data Platforms resource was discussed during the live session as well. 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.

    58 min

  2. OCT 15

    The Venn Diagram of Point of Care Trials, DCTs, and RWE

    2024-10-10 Hosts Craig Lipset, Dr. Amir Kalali, and Jane Myles were joined by Matt Veatch and Aaron Kamauu, hosts of the Real World Wednesday's Club on Clubhouse. We joined forces for a TGIF-DTRA + RWW Crossover Episode! With the release of the FDA Draft Guidance on Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice, it was the perfect topic to bring together the DCT and RWE community for a conversation around this guidance. We discussed why this guidance was aligned to RWE, the distinctions between decentralized, pragmatic, point-of-care trials, and real-world evidence, and how RCTs and DCTs can drive access for all patients. Read the guidance here --> https://www.fda.gov/media/181871/download 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.

    53 min

  3. OCT 14

    How can Academic Health Centers inject innovation back into clinical trial conduct?

    2024-10-11 Hosts Craig Lipset, Jane Myles, and Dr. Amir Kalali were joined by Donna O'Brien and Rachel Sher (Manatt) and how their work is expanding access and enrollment and driving innovation for clinical trials in academic centers. 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.

    58 min

  4. OCT 7

    Protocol Changes - Covid and Beyond

    2024-10-04 Hosts Jane Myles and special guest host Jean Sposaro (BMS) welcomed Joe Unger (Fred Hutch) for a conversation. The COVID-19 pandemic significantly decreased cancer clinical trial enrollment and swift changes were needed from researchers, regulators, and policymakers to ensure research and care could continue. He shares more about a task force created to better understand the impact of the pandemic on the conduct of oncology clinical trials. 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.

    1 hr

  5. SEP 23

    Conducting Clinical Trials with DCT Elements Guidance

    2024-09-20 Hosts Craig Lipset and Jane Myles hosted a discussion around the long-awaited FDA Final Guidance on DCTs: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties. A host of guests were brought to the stage to share perspectives on what they are excited for about this new guidance, what ambiguity was cleared up, and more! 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.

    57 min

  6. SEP 16

    DCT Adoption in Covid and Beyond

    2024-09-13 Hosts Craig Lipset and special guest hosts, Ali Holland and Pamela Tenaerts (Medable) hosted a discussion around DCT Adoption in Covid and Beyond with Dr. Pablo Cure and Thomas Radman (NCATS). In 2023, NIH NCATS posted an RFI to understand the role of decentralized methods in trials and DTRA held a listening session and created a response to the RFI with the input of our membership community. This RFI lead to an NIH NCATS 2024 DCT Report released in June 2024. We held a conversation with Dr. Cure and Thomas around catalyzing the use of these innovative methods to drive access for more patients. Blog mentioned in episode --> https://ccos-cc.ctsa.io/news/mikes-blog/you-say-po-tay-toe-and-i-say-po-tah-toe 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.

    59 min

  7. SEP 9

    Recruitment & Retention through Innovation

    2024-09-06 Hosts Craig Lipset and Dr. Amir Kalali were joined for a conversation about the Trial Innovation Network's Recruitment Innovation Center and their focus on becoming an evidence-based center for recruitment and retention strategies to improve the quality of trials and increase enrollment & health outcomes across America. We'll be joined by Paul Harris, Terri Edwards, Leslie Boone, M.P.H., Mary Stroud, and Brooklyn Henderson (Vanderbilt University) for the discussion. 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.

    56 min

  8. AUG 23

    Inspection Readiness for Decentralized Trials

    2022-12-22 Host Craig Lipset held a conversation around Inspection Readiness for Decentralized Trials. He was joined by special guests Sheila Gwizdak, Doug Shaw and John Sikora for the conversation around inspection readiness for decentralized trials and what to be thinking of, with a focus on patient safety and data integrity. 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.

    1 hr
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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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