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Artwork for Decentralized: The Decentralized Trials & Research Podcast

Decentralized: The Decentralized Trials & Research Podcast

Decentralized Trials & Research Alliance (DTRA)
Decentralized Clinical Trials
Clinical Trials
Decentralized Trials
FDA
FDA Guidance
Patient Engagement
Clinical Research
Regulatory Compliance
Patient Privacy
Patient Safety
Covid-19
Science 37
Econsent
Data Management Plan
Healthcare Providers
Data Governance
Artificial Intelligence
ICH E6 R3
Cancer Clinical Trials
Data Integrity

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 (www.clu... more

PublishesMonthlyEpisodes115Founded3 years ago
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ScienceHealth & FitnessLife Sciences

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Artwork for Decentralized: The Decentralized Trials & Research Podcast

Latest Episodes

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 recruitm... more

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. ... more

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 tri... more

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-conne... more

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Recent Guests

Paul Ivsin
Writer and consultant focused on patient recruitment
First Patient In
Episode: Recruitment: The more things change, the more they stay the same?
Patrick Lee
Senior Manager within the Digital Medicine team at Amgen
Amgen
Episode: Building Bridges: How One Team Is Connecting Innovation to Practice
Mary Thanh Hai
Director for the Office of New Drugs at CEDAR
CEDAR, FDA
Episode: Selective Safety Data Collection: When "Less" Is Better
Mitch Satka
Medical Officer in the Division of Cardiology and Nephrology
CEDAR, FDA
Episode: Selective Safety Data Collection: When "Less" Is Better
Noelle Gaskell
Executive/leader at Tempus Time Network
Tempus Time Network
Episode: Pioneering DCTs - A Community Approach
Carla Polk
Executive/leader at Tempus Time Network
Tempus Time Network
Episode: Pioneering DCTs - A Community Approach
Jane Kalali
Psychiatrist discussed in introduction
Episode: AI, Apps and Audits: The new Compliance Chaos in Clinical Research
Anna Christiansson
Site feedback and digital solutions lead at TransCelerate (AstraZeneca)
AstraZeneca
Episode: Transcelerate's Sponsor Considerations for Obtaining Site Feedback
Laura Renton
Digital enablement lead at GSK
GSK
Episode: Transcelerate's Sponsor Considerations for Obtaining Site Feedback

Hosts

Craig Lipset
Co-host and an advocate for decentralized trials, emphasizing innovation in the clinical research landscape.
Jane Myles
Co-host with a focus on improving collaboration and insights in decentralized trials.

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Talking Points

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The Power of Site Networks in Innovation
Q: Amir, I know you've got a question on your mind. Let's jump into your mind as you're thinking about the future of multi-site research.
Jim describes AMRC's aims to establish the organization, keep members informed about the political environment, and eventually provide stakeholder feedback to regulators while pursuing data collection on performance to demonstrate how MCRCs can streamline study startup and site contracts.
A Pathway to use Site-Selected Technology in Clinical Trials
Q: How do you address validation and data integrity when sites bring their own tech?
A structured validation package and ongoing validation lifecycle are essential, with sponsor accountability and interop considerations to ensure data integrity across platforms.
A Pathway to use Site-Selected Technology in Clinical Trials
Q: What is the core rationale for BYOT in trials?
BYOT aims to reduce site burden by allowing sites to use their own validated technologies, improving efficiency and data quality while maintaining regulatory compliance.
Recruitment: The more things change, the more they stay the same?
Q: What should companies do differently to make enrollment projections more realistic and data-based?
They should maintain two numbers: a fixed benchmark and a separate projection based on best available evidence, acknowledging that they may not match; this creates space to understand gaps and plan concrete actions to close them.
AI, Apps and Audits: The new Compliance Chaos in Clinical Research
Q: How should sponsors and sites approach IP and data ownership with AI tools?
Sponsors should consider robust contractual frameworks, clearly define ownership of data and workflows, and possibly implement private or on-premise AI solutions to maintain control. They should be aware of fair-use limits in AI models, potential copyright or trade-secret implications, and the need to align with evolving enforcement regimes so as to avoid inadvertent disclosure or data leakage.

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Frequently Asked Questions About This Podcast

What is This Podcast about and what kind of topics does it cover?

This podcast explores crucial topics surrounding decentralized clinical trials (DCTs), focusing on innovations, regulatory challenges, and strategies for enhancing patient engagement in clinical research. It features discussions with leaders in the clinical research community who share their insights on various aspects such as FDA regulations, data governance, and the integration of emerging technologies like AI in clinical trials. Additionally, the format allows for real-time interaction with audiences during live sessions, making the content both timely and relevant. With a strong emphasis on community voices and patient-centric designs, the discussions provide a forward-looking perspective on the future of clinical research.

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1. Anderson Cooper 360

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this podcast launched 3 years ago and published 115 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on this podcast?

Recent guests on this podcast include:

1. Paul Ivsin
2. Patrick Lee
3. Mary Thanh Hai
4. Mitch Satka
5. Noelle Gaskell
6. Carla Polk
7. Jane Kalali
8. Anna Christiansson

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