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PODCAST

Decentralized: The Decentralized Trials & Research Podcast

Decentralized Trials & Research Alliance (DTRA)

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

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All Episodes

54:22

Increasing Adoption of Wearables in Clinical Trials

Decentralized: The Decentralized Trials & Research... ·

2024/11/25

2024-11-22 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Keith Robinson, MD, MS, FCCP and Megan Parisi, MS, CCRP from Syneos Health and Nick Delmonico from Strados Labs for a discussion around wearables. We discussed challenges in increasing adoption of wearables, factors that are holding things back from greater widespread adoption, and the benefits/ROI of wearables and novel measurements.You can join TGIF-DTRA Sessions live on LinkedIn Live Audio on Friday's at 12:00 PM ET by

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57:34

Unlocking the Potential of Clinical Trial Data: New...

Decentralized: The Decentralized Trials & Research... ·

2024/11/04

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

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53:20

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

Decentralized: The Decentralized Trials & Research... ·

2024/10/15

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 With the release of the FDA Draft Guidance on Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice, it was the perfect topic to bring together the DCT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

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57:41

How can Academic Health Centers inject innovation...

Decentralized: The Decentralized Trials & Research... ·

2024/10/14

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.

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01:00:12

Protocol Changes - Covid and Beyond

Decentralized: The Decentralized Trials & Research... ·

2024/10/07

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

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57:14

Conducting Clinical Trials with DCT Elements Guidance

Decentralized: The Decentralized Trials & Research... ·

2024/09/23

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

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59:23

DCT Adoption in Covid and Beyond

Decentralized: The Decentralized Trials & Research... ·

2024/09/16

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

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56:20

Recruitment & Retention through Innovation

Decentralized: The Decentralized Trials & Research... ·

2024/09/09

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

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59:48

Inspection Readiness for Decentralized Trials

Decentralized: The Decentralized Trials & Research... ·

2024/08/23

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

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58:39

Decentralized Clinical Trials in the Trial Innovation...

Decentralized: The Decentralized Trials & Research... ·

2024/07/29

2024-07-26 Hosts Craig Lipset and Jane Myles were joined by Sarah Dunsmore (NIH/NCATS), Paul Harris (Vanderbilt University), and Daniel Hanley (Johns Hopkins University) for a discussion around the use of decentralized elements and methods in the Trial Innovation Network. Read more about the trials conducted that included decentralized elements in their paper here --> https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10465321/Learn more about the Trial Innovation Network on their website -->

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01:00:17

Patient Centricity by Design

Decentralized: The Decentralized Trials & Research... ·

2024/07/22

2024-07-19 Hosts Jane Myles and Angela Radcliffe were joined by Alicia C. Staley from Medidata Solutions for a fabulous conversation about her whitepaper on Medidata's Patient Centricity by Design (PCbD) process and the work they are doing toaccommodate the perspectives and preferences of patients and caregivers.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

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57:55

Navigating eConsent Implementation Chaos

Decentralized: The Decentralized Trials & Research... ·

2024/07/15

2024-07-12 Hosts Craig Lipset and Jane Myles joined us for a discussion with Irina Grishina and Liz Quinlan (CSL Behring) about eConsent and challenges and successes with implementation.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.

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58:41

Building Clinical Trial and Health Research Access...

Decentralized: The Decentralized Trials & Research... ·

2024/07/01

2024-06-28 Hosts Dr. Amir Kalali and Jane Myles were joined by Pete Fronte (Altura Health), Ruma Bhagat (Genentech) and Dr. Jim Schultz (Neighborhood Health) to discuss a white paper and toolkit released about Building Clinical Trial & Research Access via Community Health Centers. We look forward to hearing more about their work to engage underrepresented populations to diversify research enrollment.View the white paper/toolkit here -->

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56:29

FDA Inspection of a Decentralized Meta-Site

Decentralized: The Decentralized Trials & Research... ·

2024/06/24

2024-06-21 Hosts Craig Lipset, Dr. Amir Kalali, and Jane Myles were joined by Jonathan Cotliar (Science 37) for a discussion around their recent successful FDA Inspection of a decentralized meta-site, which is a huge milestone in virtual site quality assurance and compliance.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

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01:01:30

Data Diversity, Data Access, and Rights

Decentralized: The Decentralized Trials & Research... ·

2024/06/17

2024-06-14 Hosts Dr. Amir Kalali and Jane Myles were joined by Anthony Costello (Medidata) for a conversation around data diversity, data access, and rights, and his experience at Medidata, as well as industry wide.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.

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57:51

Data on the Adoption of Decentralized Methods in...

Decentralized: The Decentralized Trials & Research... ·

2024/06/12

2024-06-11 Hosts Craig Lipset, Dr. Amir Kalali, and Jane Myles were joined by Dr. Timil Patel, a Medical Oncologist with the FDA for a discussion around the recently released ASCO abstract around adoption of decentralized trial elements in cancer clinical trials during the pandemic.Clinical Trials Transformation Initiative (CTTI) and FDA (with support from Decentralized Trials & Research Alliance (DTRA) collected data from research sponsors to understand the methods that were adopted, the

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57:54

Sponsor Experience Implementing DCTs

Decentralized: The Decentralized Trials & Research... ·

2024/06/10

2024-06-07 Host Craig Lipset was joined by a special guest host, Jean Sposaro (BMS) for our session around Sponsor Experience Implementing DCTs. TransCelerate Bio Pharma conducted a survey in 2023 to better understand the collective experience of TransCelerate members deploying decentralized clinical trial (DCT) elements beyond the COVID-19 pandemic. Ashley Butler (TransCelerate) and Joachim Lovin (Novo Nordisk) joined us for the discussion. TransCelerate's recently released whitepaper can be found

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50:10

TGIF-DTRA Ask Us Anything DCT Edition

Decentralized: The Decentralized Trials & Research... ·

2024/06/05

2024-05-31 Hosts Amir Kalali and Jane Myles joined allowed guests to join as ask their burning questions about all things DCT. A discussion about the EX-US Market in Japan, adoption of DCT methods, and more were addressed during the live session.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

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55:06

RBQM and Decentralized Trials

Decentralized: The Decentralized Trials & Research... ·

2024/05/24

2022-10-21 Hosts Craig Lipset and Jane Myles chatted with John Hall (CluePoints), Joe Dustin (previously Medable) and Daniel DiJohnson (Parexel) about risk based quality monitoring and how it fits into DCTs.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.

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57:50

Let's Celebrate Clinical Trials Day!

Decentralized: The Decentralized Trials & Research... ·

2024/05/20

2024-05-17 Hosts Amir Kalali, MD, Craig Lipset, and Jane Myles were joined by industry champions Terttu Haring (Syneos Health), Kelly McKee (Evinova), and Beth Brooks (Sanofi) to discuss raising awareness of clinical trials, why clinical trials day matters, and how they embody this in their day-to-day work.We are excited to celebrate Clinical Trials Day on Monday, May 20.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

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