Decentralized: The Decentralized Trials & Research Podcast

2025-01-29 Hosts Craig Lipset and Jane Myles hosted a great discussion with Hilde Vanaken ( EFGCP - European Forum for Good Clinical Practice ) and Katrin Ong ( Boehringer Ingelheim ) to share about the suite of tools created by the European Forum for Good Clinical Practice's eConsent initiative and how they can be used to demystify eConsent. There are many resources available for use. Review the...

2025-01-17 Irfan Khan, MD ( Circuit Clinical ) joined hosts Craig Lipset and Jane Myles for a discussion around what HCPs think about clinical research and how to gain their support on routine care in clinical trials. We discuss the journey of HCPs becoming investigators and what we need to drive this forward in the community. You can join TGIF-DTRA Sessions live on LinkedIn Live on Friday's at 12...

2024-12-20 Hosts Amir Kalali, Craig Lipset, and Jane Myles came together for the final TGIF-DTRA of the year, 2024 in Review! We shared more about what we did in 2024 at DTRA, what has been happening in the ecosystem, and some predictions for 2025! 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 &a...

2024-12-06 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Anna Yang and Elizabeth Mandel (Genentech) joined us for a discussion around defining, measuring, and benchmarking data quality with 2 ongoing hybrid studies. 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 All...

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 mea...

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 c...

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...

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...

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...

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!...

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 comm...

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,...

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...

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.g...

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 12:0...

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 ab...

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 enro...

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...

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 L...

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 Alli...

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...

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 &amp...

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...

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 S...

2024-05-10 Hosts Amir Kalali and Jane Myles were joined by Dr. David Waterhouse (Oncology & Hematology Care) to discuss transforming clinical trials to enable cancer patients to participate closer to home. The paper discussed during the session is available here . Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X . Learn more about Membership and our work at www....