{"podcast":{"title":"Decentralized: The Decentralized Trials & Research Podcast","slug":"decentralized-the-decentralized-trials-research-podcast-6281264","podcast_index_feed_id":6281264,"rss_url":"https://feeds.captivate.fm/decentralized-podcast/","website_url":"https://www.dtra.org","image_url":"https://artwork.captivate.fm/196acf6b-0c14-4480-94cb-365b0129ceca/WP9VB6OATbVh2ov42feJLjKF.jpg","author":"Decentralized Trials & Research Alliance (DTRA)","episode_count":116,"summary":"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.","last_synced_at":"2026-06-09T04:17:52.611525+00:00","page_url":"https://stenobird.com/podcast/decentralized-the-decentralized-trials-research-podcast-6281264"},"episode":{"title":"Navigating US Regulatory Change in an unpredictable environment","slug":"navigating-us-regulatory-change-in-an-unpredictable-environment","published_at":"2025-04-28T13:00:00+00:00","page_url":"https://stenobird.com/podcast/decentralized-the-decentralized-trials-research-podcast-6281264/navigating-us-regulatory-change-in-an-unpredictable-environment","show_page_url":"https://stenobird.com/podcast/decentralized-the-decentralized-trials-research-podcast-6281264","url":"https://www.dtra.org","audio_url":"https://dts.podtrac.com/redirect.mp3/podcasts.captivate.fm/media/02a1693b-3c7f-43d8-aa4b-ec0e88d1fdea/My-Movie-3-converted.mp3","summary":"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 here Megyn Kelly Show with Dr. Martin Makary, new FDA Commissioner 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 .","meta_description":"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 enviro…","key_points":[],"chapters":[],"topics":[],"duration_seconds":3565,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/decentralized-the-decentralized-trials-research-podcast-6281264/episodes/navigating-us-regulatory-change-in-an-unpredictable-environment/transcription-requests","description":"Idempotently request low-priority transcript generation for this episode."},{"name":"read_markdown","method":"GET","url":"https://stenobird.com/podcast/decentralized-the-decentralized-trials-research-podcast-6281264/navigating-us-regulatory-change-in-an-unpredictable-environment.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}