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Decentralized: The Decentralized Trials & Research Podcast

Decentralized: The Decentralized Trials & Research Podcast

A space for all who want to improve access for clinical research and participation.

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.
September 23, 2024

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-toeYou 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.
September 16, 2024

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.
September 9, 2024

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.
August 23, 2024

Decentralized Clinical Trials in the Trial Innovation Network

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 --> https://trialinnovationnetwork.org/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.
July 29, 2024

Patient Centricity by Design

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 to accommodate 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 LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.
July 22, 2024

Navigating eConsent Implementation Chaos

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.
July 15, 2024

Building Clinical Trial and Health Research Access via Community Health Centers

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 --> https://alturastudies.com/research-ecosystems/#researchdiversitywhitepaperYou 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.
July 1, 2024
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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). This is a space for all who want to improve access for clinical research and participation. New topics are covered every week live on Clubhouse with guest speakers in the industry to talk about the latest ways to make research and clinical trials more inclusive, accessible, resilient, and sustainable by using decentralized methods.

Team

Craig Lipset

Craig Lipset

Craig Lipset (he/him/his) leads at the forefront of innovation in clinical research and medicine development. He is an advisor to technology and biopharmaceutical companies, leading universities, and the venture community, bringing vision and driving action at the intersection of research, digital solutions, and patient engagement. Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures (Perceptive Informatics and Adnexus Therapeutics). During that time, Craig designed and launched multiple industry firsts -- from the first fully remote/virtual clinical trial for a new medicine to the first returning of results and data to research participants.

He currently serves on the Board of Directors for the Decentralized Trials & Research Alliance (Co-Chair), Foundation for Sarcoidosis Research and the MedStar Health Research Institute, and, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. Craig is an Adjunct Assistant Professor in Health Informatics at Rutgers University, and an Adjunct Instructor at the University of Rochester Center for Health + Technology.

Craig has received the red jacket 'hall of fame' recognition among the PharmaVOICE most inspiring people in the life sciences. He has been recognized among Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, the Medicine Maker Power List and the AlleyWatch Who's Who in eHealth. He studied Music at Brandeis University and earned a Master of Public Health from Columbia.
Amir Kalali, MD

Amir Kalali, MD

Dr. Kalali is a physician-scientist, recognized globally as a leading innovator at the intersection of life sciences and technology, and a convener of collaborative high-impact forums. He is a board director of both private and publicly traded companies, and advises companies in the life sciences and technology sectors, universities, and investment groups. Dr. Kalali is the Co-Chair of the Decentralized Trials and Research Alliance (DTRA), Chairman and Chief Curator of the CNS Summit, a forum focused on the future of life sciences, and was the Founding Chairman, and sits on the Executive Committee of the International Society for CNS Drug Development (ISCDD), one of the first independent non-profits to bring together leaders in drug development to collaborate, and on the Executive Committee of the International Society for CNS Clinical Trials and Methodology (ISCTM).

He is a Professor of Psychiatry at the University of California San Diego, Editor of the journal Innovations in Clinical Neuroscience, and the Lead Editor of the book Essential CNS Drug Development., published by Cambridge University Press. He has authored over 250 peer-reviewed publications, and numerous book chapters. He has been involved in initiatives by the Institute of Medicine, as well as the NIH FAST and the NIH NCATS programs. Previously, for almost 20 years, he was the Global Head of the Neuroscience Center of Excellence at Quintiles, now known as IQVIA.

In this role, he led the enterprise-wide strategy for neuroscience, encompassing drug development and health care services. He was responsible for numerous successful drug development programs that have led to dozens of approved new treatments for patients. Dr. Kalali regularly speaks at national and international scientific meetings on topics including drug development, clinical trials, innovation, technology, digital medicine, biohacking, and health. Dr. Kalali’s contributions have been recognized by life sciences media including The Medicine Maker’s Power List and the PharmaVOICE magazine’s Inaugural Red Jacket award, recognizing those who have been most lauded by their peers

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