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

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Publishes	Monthly	Episodes	118	Founded	3 years ago
Number of Listeners		Categories	Life SciencesHealth & FitnessScience

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Latest Episodes

Project Loom: Can AI Orchestrate the Future of Clinical Trials?

2026-07-24 In this episode of TGIF-DTRA, hosts Jane Myles, Craig Lipset, and Dr. Amir Kalali are joined by Donna Parker and Christoph Hornick from Duke University's iCubed to explore Project Loom, an initiative testing how agentic AI can support clin... more

28 Jul 2026 • 58 min

TGIF-DTRA: Protocol Simulations

2026-06-12 Hosts Jane Myles and Jean Sposaro were joined by Rachel McGovern (Boehringer Ingelheim) who shared how a simple but powerful “mock trial walkthrough” helped uncover protocol and operational challenges before a clinical trial ever enrolled ... more

15 Jun 2026 • 59 min

The Digital Evolution of DTRA

2026-05-29 DTRA is entering a new chapter. In this special episode, Craig Lipset, Amir Kalali, and Jane Myles discuss the evolution of DTRA from the Decentralized Trials & Research Alliance to the Digital Trials & Research Alliance. Hear why the chan... more

8 Jun 2026 • 12 min

Recruitment: The more things change, the more they stay the same?

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

13 Apr 2026 • 57 min

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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

Jane Miles

Host of the TGIF DTRA conversations and show facilitator, frequently guiding discussions with guests.

Amir Kalali

Host and discussion facilitator with a focus on DCT strategy, change management, and cross-functional collaboration.

Chart Rankings

How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.

Apple Podcasts	#229	United Kingdom/Science/Life Sciences
Apple Podcasts	#91	Finland/Science/Life Sciences
Apple Podcasts	#114	Russia/Science/Life Sciences
Apple Podcasts	#130	Israel/Science/Life Sciences

Talking Points

Recent interactions between the hosts and their guests.

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 program focuses on decentralized trials and the broader clinical research ecosystem, with recurring conversations around DCT adoption, site and sponsor dynamics, regulatory considerations, and patient engagement. Episodes often feature senior industry leaders, regulatory perspectives, and researchers discussing practical implementations, governance, and real-world challenges in scaling decentralized approaches. A standout pattern is the emphasis on balancing innovation with safety, data quality, and sponsor-site collaboration, along with hands-on frameworks, playbooks, and case studies that listeners can map to their own programs. The show tends to blend operational detail with strategic insight, making it useful for sponsors, CROs, si... more

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this podcast launched 3 years ago and published 118 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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