
DTRA Download: The Digital Trials & Research Podcast
Digital Trials & Research Alliance (DTRA) 120 episodes Sep 21, 2026
DTRA Download is a podcast from the Digital Trials & Research Alliance (DTRA). Each episode features leaders from the innovative trials and clinical research community. Guests share their insights and vision for the future of research. Listeners can connect with DTRA on LinkedIn to learn more about the organization.
Episodes

Clinical Trials Beyond Walls: Building Choice Into Clinical Research
2026-09-11 Hosts Craig Lipset and Jane Myles were joined by Becky Kottschade and Dr. Tufia Haddad from the Mayo Clinic to share the evolution of Clinical Trials Beyond Walls, Mayo Clinic’s program for bringing digital and decentralized capabilities into clinical research.Building on Mayo’s experience with remote patient monitoring, the team started by centralizing capabilities, establishing best p

Reflections from the Life Science Technology Forum in China: Scale, Speed, and Ambition
Our hosts, Dr. Amir Kalali, Craig Lipset, and Jane Myles were joined by Owen Muir (Radial) to share insights from Beijing from the Life Sciences Technology Forum earlier this year. Notes on what they saw, heard, and learned about the rapidly evolving life sciences landscape in China were shared.The conversation explores the speed and scale of technology adoption, China's growing sophistication in

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 clinical trial operations.The conversation covers where AI excelled, drafting protocols, informed consent forms, IRB submissions, and case report forms, a

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 a patient. By simulating key study visits from both patient and site perspectives, Rachel and her team identified opportunities to reduce burden, impr

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 change reflects the needs of DTRA's membership, how decentralized research remains a cornerstone of the organization's mission, and what's ahead a

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 recruitment success and site-level performance, challenged common industry myths, and highlighted the gap between enrollment projections and real-world results.

Building Bridges: How One Team Is Connecting Innovation to Practice
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. They discuss launching decentralized clinical trials (DCTs), including a hands-on workshop with 50+ medical colleagues, and their approach to change m

Selective Safety Data Collection: When "Less" Is Better
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 trials when a drug’s safety profile is already well-established. Mary Thanh Hai and Mitch Psotka explained that SSDC, formalized through FDA guidance and I

Pioneering DCTs - A Community Approach
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-connected site network, genomics capabilities, and operational model help match patients faster, streamline startup timelines, and support community practi

Why People Stay (Or Don't)/ Rethinking Participation in Modern Trials
2025-11-14 - Hosts Amir Kalali and Jane Myles were joined by Alex Charge (ISPEP) and Stacey Davidson (Cuttsy+Cuttsy) on what today’s clinical trial participants experience from start to finish. Drawing on new research conducted by their organizations, the conversation unpacks how patients discover trials, why they join, and what drives both positive experiences and early dropout. Key themes includ

AI, Apps and Audits: The new Compliance Chaos in Clinical Research
2025-10-24 Hosts Amir Kalali, Craig Lipset, and Jane Myles were joined by Darshan Kulkarni, a pharmacist, lawyer, and educator, for a fantastic conversation around the intersection of healthcare innovation, regulatory law, and emerging technologies. Listeners will learn more on:Challenges in AI protocol protection and data privacy under HIPAA, GDPR, and global lawsThe tension between innovation an

Transcelerate's Sponsor Considerations for Obtaining Site Feedback
2025-10-03 Hosts Amir Kalali, Craig Lipset, and Jane Myles were joined by representatives from TransCelerate BioPharma Inc.’s Modernizing Clinical Trial Conduct initiative for our discussion. This initiative is helping the industry move beyond pandemic-era adaptations toward lasting transformation. In this session, we highlighted a newly released tool designed to help sponsors collect meaningful s

Digital Therapeutics in Decentralized Trials
2025-09-12 Our hosts Dr. Amir Kalali and Jane Myles were joined by Cinja Nadana Koller and Marc Blanchard, affilated with CHUV | Lausanne university hospital to discuss their joint paper on an assessment of digital therapeutics in DCTs. In this episode, we dove into the intersection of decentralized clinical trials (DCTs) and digital health technologies (DHTs), with a spotlight on rheumatolog

Home visits for Rare Disease Research
2025-08-22 Hosts Craig Lipset and Jane Myles hosted a conversation with Alpa Kushillani, VP of Customer Success & Delivery with Gooseberry Research and a rare disease advocate. Alpa shares her family’s journey with Duchenne muscular dystrophy and how those experiences inspired her to create new solutions for patient-centered research.We explore the realities of clinical trial participation for

A Pathway to use Site-Selected Technology in Clinical Trials
2025-08-01 Hosts Dr. Amir Kalali and Jane Myles discussied DTRA's Bring Your Own Technology initiative with leaders Brandon Maggio (GSK) and Joe Dustin (Dauntless eClinical Strategies).Sites are managing 20+ systems per trial, leading to fatigue and friction. DTRA’s BYOT (Bring Your Own Technology) initiative aims to empower sites to use their own validated tools like eConsent and eSource. Hear ho

Including HCPs in Clinical Trials
2025-07-18 Hosts Craig Lipset, Jane Myles, and Dr. Amir Kalali were joined by Shelly Barnes (UCB), Brittany Niland (Eli Lilly and Company) and Erica Coles Jacobsen (Konovo) for a discussion around healthcare providers (HCPs) and their involvement in clinical research. DTRA has partnered with Eli Lilly and Company and Konovo to better understand the sentiment of these HCPs around participating in c

DIA Roundup
2025-06-27 Hosts Craig Lipset and Jane Myles shared about all things DIA Global Annual Meeting 2025. They shared more about key discussions and themes seen on the stage and in sessions and shared insights from attending the event this year. Additionally, Jane Myles shared more about her panel discussion on HCPs participating in research.You can join TGIF-DTRA Sessions live on LinkedIn Live on Frid

The Power of Site Networks in Innovation
2025-06-16 Hosts Craig Lipset, Dr. Amir Kalali, and Jane Myles held a conversation with Jim Kremidas (Association of MultiSite Research Corporations) to share more about his personal journey as a clinical trials patient, his career in clinical research, and his work now with AMRC around innovation for sites.You can join TGIF-DTRA Sessions live on LinkedIn Live on Friday's at 12:00 PM ET by checkin

Trial By Experience: Living both sides of Clinical Research
2025-05-16 In honor of Clinical Trials Day (May 20), we look forward to featuring individuals who’ve not only worked behind the scenes in clinical research but have also stepped into the role of participant. Join us to hear how their personal experiences reshaped their professional perspectives, deepened their empathy, and changed how they think about the future of trials through their learned exp

From Idea to Digital Measurement via DCT
2022-06-10 Hosts Craig Lipset and Amir Kalali were joined by Francesca Rinaldo (prev. Sharecare, now SCAN) and Emily Lewis (UCB) around opportunities to impact myasthenia gravis patients and researchers with better digital measurements on a smartphone.You can join TGIF-DTRA Sessions live on LinkedIn Live on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials &

Navigating US Regulatory Change in an unpredictable environment
2025-04-25 Hosts Craig Lipset and Jane Myles were joined by Greg Dombal and Laura DiAngelo (Agency IQ) to discuss the rapidly changing regulatory environment in the US, particularly in the clinical research sector, and its implications for those operating in this highly regulated space. The participants discussed the impact of recent changes such as reductions in force and reorganizations on the i

Navigating the ICH E6 R3 with tools & solutions
2025-04-11 Hosts Craig Lipset and Jane Myles were joined by our partners TransCelerate BioPharma Inc. and ACRO for a discussion on their tools & solutions that were developed to better understand the ICH E6 R3. We welcomed Christine Goffe (UCB), Paul Slagle (IQVIA), and Hasnaa Likaoui (BMS) to share about the data lifecycle framework tool and the trial design considerations tool that they have

Bringing Community Oncologists into Trials
2025-04-04 Hosts Craig Lipset and Jane Myles were joined by Kaitlin Morrison from UNC Lineberger Comprehensive Cancer Center. She shared her experiences with the potential of decentralized clinical trials, particularly in oncology, to expand participation beyond academic medical centers. We discussed the challenges of conducting clinical trials, the importance of trust and information sharing in b

Patient Experience Ratings & Decentralized Trials
2022-03-18 Host Craig Lipset was joined by Irfan Khan (Circuit Clinical), Kelly McKee (Evinova), and Kerry Hicks (HW Investment Partners) for a conversation around the application of patient experience in clinical research, health ratings for providers, and more.You can join TGIF-DTRA Sessions live on LinkedIn Live on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized T

A Patient Perspective on the DCT Field
2022-03-11 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Stacy Hurt (Parexel) for an insightful discussion around the perspective of a patient on the DCT field.You can join TGIF-DTRA Sessions live on LinkedIn Live 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 op

Breaking Barriers in Tech Adoption & AI
2025-02-28 We welcomed Mike Wenger (FullStack Trials) and Melissa Holbrook (Clinical Research Advisory Group LLC) for a discussion around the biggest challenges in clinical trial technology adoption. We dived into getting feedback from sites, finding new ways to navigate using AI, and moreYou can join TGIF-DTRA Sessions live on LinkedIn Live on Friday's at 12:00 PM ET by checking out our LinkedIn.

SCOPE Summit 2025 Recap
2025-02-07 Hosts Craig Lipset & Jane Myles took the stage to share their thoughts around the SCOPE Summit that was held earlier this week in Orlando, FL. They covered high level findings and thoughts on the environment for 2025 and a download on a few panels they were moderated by the DTRA team.You can join TGIF-DTRA Sessions live on LinkedIn Live on Friday's at 12:00 PM ET by checking out our

From Chaos to Clarity: Defining Who Does What?
2025-01-31 Hosts Jane Myles (DTRA) and Michelle Shogren (Innovate In What You Do!) were joined by Rebecca Kottschade (Mayo Clinic) and Caroline Redeker (Advanced Clinical) to share about the work they led at DTRA around Roles and Responsibilities when using decentralized elements in clinical trials.Sites are overburdened with technology and role ambiguity as the use of DCT methods in clinical tria

Demystifying eConsent - The European Forum GCP eConsent Suite of Tools
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 resou

What is needed for HCs to support routine care in clinical trials?
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 12:00

2024 in Review
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 &am

Investigating Data Quality in Hybrid Clinical Studies
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 Alli

Increasing Adoption of Wearables in Clinical Trials
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 me

Unlocking the Potential of Clinical Trial Data: New CRDSA Standards
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 co

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

How can Academic Health Centers inject innovation back into clinical trial conduct?
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 Al

Protocol Changes - Covid and Beyond
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 t

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!Yo

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 commu

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.

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

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.g

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

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 abou

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 enro

FDA Inspection of a Decentralized Meta-Site
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

Data Diversity, Data Access, and Rights
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 Li

Data on the Adoption of Decentralized Methods in Cancer Trials During the Pandemic
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 Allia

Sponsor Experience Implementing DCTs
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

TGIF-DTRA Ask Us Anything DCT Edition
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 &

RBQM and Decentralized Trials
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 a

Let's Celebrate Clinical Trials Day!
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 Ses

Driving Oncology Trials to the Community
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.dtra

Unlocking Digital Health Tech in Clinical Trials
2024-05-03 Hosts Amir Kalali, Craig Lipset, and Jane Myles were joined by Moe Alsumidaie (The Clinical Trial Vanguard) for a robust discussion around digital health technologies and how they can be best utilizing in advancing clinical trials.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership and our work at www.dtra.org.

Building Diversity & Inclusion into Clinical Trials
2024-04-26 Our hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Otis Johnson (Trial Equity) and Jeffrey Zucker (Tekton Research) to share about how to expand clinical research opportunities to diverse populations. Trial Equity has a training curriculum to help companies achieve this goal of expanding access to patients that we explored during the conversation.Follow the Decentralized

Site Needs for Decentralized Trials
2022-10-14 Host Craig Lipset was joined by a powerhouse of site leaders for a great conversation around what sites need to make DCTs a success. Casey Orvin (CenExel), Lori Wright (ERG), Irfan Khan (Circuit Clinical), Jimmy Bechtl (SCRS), and Paul Evans (Velocity Clinical Research) joined for the conversation.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. L

Novel Platform & DCTs Drive Innovation
2024-04-12 Hosts Amir Kalali, MD and Jane Myles were joined by Stacey Adam, Vice President, Science Partnerships for the Foundation for National Institute of Health. She shared about her experiences with platform trials, DCT methods, and how they are working to drive innovation further for patients.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more a

What Evidence do you need for DCTs and how to find it?
2024-04-05 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by several members of the research community for a robust discussion about how to find evidence of impact, our efforts to make it available in the DTRA Library, and ways we can continue working to find this evidence to drive adoption of DCTs.The DTRA Library can be accessed here and is available to all. We are asking for you to

Clinical Trial Matching Solutions: Is it Solved?
2024-03-29 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Todd Georgieff (futurpositif - Digital Clinical Trials Consulting), Jennifer Clauson (Dyania Health) and Brandon Li (Power) for a discussion around the approaches to matching patients for clinical trials and different methods and ideas on how we can better the trial matching process today.

Is there evidence for what eConsent features patients prefer?
2024-03-22 Hosts Craig Lipset and Jane Myles dove into a conversation with Andrew Mackinnon (Medable) about their work with Duke on patient preference in an eConsent study. Learn more about the Pilot Study here --> https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-023-01432-wFollow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn mor

Growing Enthusiasm for DCTs in Pakistan
2024-03-15 Hosts Craig Lipset and Jane Myles were joined by Jonathan Ernst (PCM Trials) and Ghazala Kabani (Integrity ClinOps Consulting) for a discussion around the growing interest and excitement for decentralized clinical trials in Pakistan.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Lab Specimen Logistics in Decentralized Trials
2022-04-29 Hosts Amir Kalali and Craig Lipset were joined by Shawn Tedman (ixlayer) and Beth Culver (MRN) to discuss lab specimens and the logistics of obtaining them from patients when the trials are being run from home.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Rare Disease Day + Mint Trial
2024-03-01 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Dr. Rohit Aggarwal to share his experience and expertise regarding the MINT study and the work he has accomplished thus far in the rare disease space.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Bring Your Own Tech: Oncology Trials
2024-02-23 Join hosts Jane Myles and Joe Dustin for a conversation with Noelle Gaskill (BMS) around site centric DCT approaches and how some key components could make a hybrid DCT successful in interventional oncology.

Techquity - Digital as a Bridge, Not a Divide
2024-02-16 Hosts Craig Lipset and Jane Myles were joined by Vik Kheterpal (CareEvolution), Dr. Apruv Soni (Univers of Mass.), and Dr. Ed Ramos to discuss findings and data from digital studies/interventions that can really address inequities in healthcare and reaching underserved populations.A great conversation was had about expanding the dialogue around the digital ecosystem for healthcare innov

CRAFT Hybrid DCT Model Strategy
2024-02-09 Hosts Craig Lipset and Jane Myles were joined by Stephen Sundquist (3CTN) and Bianka Courcelle (HSJ) to discuss the PI site perspective and experiences in implementing a trial cluster involving a satellite site in supporting patient access. The specific clinical trial case illustrates how the CRAFT hybrid DCT approach was applied to support collaboration between the pediatric cance

Mergers & Acquisitions in DCT
2024-02-02 Hosts Craig Lipset and Jane Myles were joined by Chunky Satija (Everest Group) for a discussion around mergers & acquisitions in the DCT space and what we may see on the horizon as the market evolves throughout the year.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Importance of Chief Patient Officer in Life Sciences Orgs
2024-01-26 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by the fabulous Stacy Hurt (Parexel) to discuss the importance of the Chief Patient Officer (CPO) role in the life sciences industry. A great conversation was had about how the CPO is uniquely positioned to improve patient access and experience. A link to the CTTI paper on ROI & engagement that was discussed during the sess

AI & Clinical Trial Efficiency
2024-01-19 Hosts Craig Lipset and Jane Myles were joined by Derk Arts (Castor) for a riveting conversation about the future of AI in clinical trials and how we can utilize this technology to make trials more efficient.Learn more about DTRA Circles, especially the AI Circle kicking off in January 2024.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more

AI in Clinical Trials & Care
2024-01-12 Hosts Craig Lipset and Jane Myles were joined by guests Ritesh Patel and Gil Bashe (FINN Partners) and Sarah Schmachtenberg (Galen Growth) to discuss how AI can be used in clinical trials and care for patients.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Resilience Framework in Clinical Trials
2024-01-05 Our hosts Amir Kalali, Craig Lipset, and Jane Myles were joined by Aditi Hazra with Harvard Medical School for a compelling discussion around implementing resilience framework in clinical trials.Several references were discussed during the episode from the FDA and EMA.1) FDA-2023-D-3550: “Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions

Holistic Patient Support in Decentralized Trials
2022-04-08 What do we need to think about beyond individual technical needs in trials? How far does support need to extend to be meaningful and impactful, especially as we explore studies with less interaction with a traditional site using decentralized methods? Hosts Craig Lipset and Amir Kalali were joined by Animesh Pandeya (IQVIA), Jen Horonjeff (Savvy Cooperative), and Graham Wylie (MRN) for

Do Decentralized Trials Really Impact Diversity?
2022-06-07 Join us to discuss diversity in decentralized trials as we demystify and debunk the optimism, hope, and perhaps the hype around this topic. Hosts Craig Lipset and Amir Kalali were joined by Noah Goodson (THREAD) Jayne Morgan (Piedmont) for the discussion.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at ww

2023 Decentralized Trials Wrap Up
2023-12-15 Join us to hear about everything we accomplished as a community in 2023 - many great highlights and acheivements while looking forward to what is to come in 2024. This session was hosted by Craig Lipset, Jane Myles, and Amir Kalali.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

What is GCP, really?
2023-12-08 Join us for a riveting conversation with Ahmad Namvargolian from Care Access around what GCP really is in clinical trials. Hosts Craig Lipset and Jane Myles joined for the conversation.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Data Connectivity and Interoperability
2023-12-01 DTRA Initiative Leaders Munther Baara (Edetek) and Moulik Shah (Advanced Clinical) to discuss Data Connectivity and Interoperability in DCTs and how it can be done with study teams now.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

From Chaos to Quality in DCTs
2022-03-25 Join hosts Craig Lipset and Amir Kalali alongside MaryAnne Rizk (Rizk Management Advisors) and Rohit Nambisan (Lokavant) to discuss how we maintain quality in trials and what is the role of data & analytics in this area.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Mythbusting If DCTs Must Be "All or Nothing"
2022-06-24 Our hosts were joined by Julie Lin and Kim Hawkins (Sanofi), and Alexander Pastuszak (Contraline, previously Vault Health) to discuss whether or not the use of DCT methods has to be "all or nothing."Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

The Business Case for DCTs
2023-11-03 Join host Craig Lipset and special guest host Angela Radcliffe for a great session with Madeline Geday (Astellas) around the Business Case for DCTs.Hear how and why including the DCT model as part of protocol design supports organizations to find the right balance operationally and makes the patients’ lives easierLearn about the wide range of fact

TGIF-DCT: MRCT/Medable IRB/Ethics Taskforce in DCT recommendations
2023-10-27 Craig, Amir, and Jane were joined by Pamela Tenaerts, MD, MBA and Leanne Madre (Medable, Inc) as well as Barbara Bierer (Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) to discuss the tools and resources created for IRB/EC considerations in DCT. Follow the Decentralized Trials & Research Alliance (DTRA) on
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