Decentralized: The Decentralized Trials & Research Podcast

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.

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 associated challenges to address, and the direction ahead.

Read the ASCO abstract here --> https://meetings.asco.org/abstracts-presentations/237149

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.

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 here --> https://www.transceleratebiopharmainc.com/wp-content/uploads/2024/04/Sponsor-Experience-Implementing-Decentralized-Clinical-Trial-DCT-Elements-DCT-Implementation-Survey-Results_vFINAL-1.pdf

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.

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 www.dtra.org.

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.

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 Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.

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.org.

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 Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership and our work at www.dtra.org.

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.

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. Learn more about Membership and our work at www.dtra.org.

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 about Membership and our work at www.dtra.org.

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 make submissions of additional case studies, white papers, articles, and more so we can continue to grow the library for all.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

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.

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-w

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

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.

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.

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.

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.

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 innovation.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

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 cancer centre and an adult centre in supporting an AYA patient on trial.

A great conversation was had about how the CRAFT hybrid DCT Framework; why it was built, how it was constructed, and why it matters.

Site Supervision Template: https://3ctn.ca/wp-content/uploads/2022/04/CRAFT-Site-Supervision-Plan_WM.pdf

CRAFT Framework: https://3ctn.ca/for-researchers/craft/

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

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.

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 session is linked here.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

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 about Membership and our work at www.dtra.org.

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.

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 Due to Disasters and Public Health Emergencies”

https://www.federalregister.gov/documents/2023/09/21/2023-20474/considerations-for-the-conduct-of-clinical-trials-of-medical-products-during-major-disruptions-due

2) European Medicines Agency: https://www.ema.europa.eu/en/impact-war-ukraine-methodological-aspects-ongoing-clinical-trials-scientific-guideline

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

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 the conversation.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

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 www.dtra.org.

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.

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.

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.

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.

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.

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 easier
• Learn about the wide range of factors that need to be considered when determining the risk vs the benefit to a study
• Discuss how to determine what will work in your organization by using a decision-making process that finds the right methodologies and technologies which are dependent on the therapeutic and patient population

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

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 LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-10-20 Join us to hear from Emily Mitchell and Madelaine MacKay from ICON and Meghan Dixon with Accellacare to discuss lessons learned and experiences with DCT adoption with PIs and study staff at a dedicated and embedded site network.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-10-13 TGIF-DCT mashup with Real World Wednesdays! We were thrilled to welcome The hosts of Real World Wednesdays (https://lnkd.in/eMTGG25j) -- Matt Veatch and Aaron Kamauu MD MS MPH join us for a discussion on how Real World Data intersects with decentralized trials.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2022-04-01 Join us to learn about what a Research Site today and how decentralized methods can be part of some or many parts of a trial. Hosts Craig and Amir were joined by Lori Wright and Andria Chastain (Evolution Research Group) and Samantha Eells (Lightship)

2023-09-15 Join us to hear from Jane Myles (Decentralized Trials & Research Alliance (DTRA) and Christine Von Raesfeld (People with Empathy) sharing more about the Data and the Keys to Patient Empowerment. They'll be discussing a future where patients are the decision makers about who has access to their data, and where trials are a part of their care options by design. Our Co-hosts were joined by DTRA Co-Founders Craig Lipset 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.

For the 1 in 5 Americans living in rural or frontier communities, clinical trial participation poses significant challenges due to travel burden, reduced healthcare access, and lack of awareness of trial opportunities. Through a novel collaboration with rural-focused researchers, University of Washington is looking to tackle some of the toughest aspects of initiating decentralized trials in these remote regions to extend opportunity equity.

Hosts Craig Lipset, Jane Myles, and Amir Kalali were joined by Elizabeth Johnson, PhD, MS-CRM, RN (Montana State University-Bozeman), Christopher Goss (University of WA), and Margaret Rosenfeld (Seattle Children's) for the discussion.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-09-22 Our host Jane Myles was joined by Ingrid Oakley-Girvan with Medable to share data from the field around the DCT Participant Experience and her perspectives as a physician in the field.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-09-08 Join us to hear about all things DTRA Circles. These functional collaboration groups were built around areas of interest for our members, such as Diversity, Data Management, Patient Voice, and more. Sarah McKeown-Cannon and Deena Bernstein joined us 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.

2022-01-28 What comes from bringing together networks of investigators with established technology platforms in the space? Our hosts Craig Lipset and Amir Kalali were joined by Kelly McKee (Medidata) and Irfan Khan (Circuit Clinical) 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.

2022-05-13 Join us to hear from Ardy Arianpour (SEQSTER) and Marjorie Tan-Thronson (Salesforce) to hear about the use case, barriers, and challenges around whether or not patients can bring their EHR data into prospective trials and what it means for patients.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-04-15 Jennifer Price (THREAD) and Jeremy Wyatt (ActiGraph) joined our hosts Amir Kalali and Craig Lipset to discuss wearables and how they can be used in DCTs. Areas of focus were how to properly support the patient, interpreting the data, and the barriers in the adoption of wearables.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2022-01-14 A whitepaper around research that helped quantify the ROI of Decentralized Trials inspired this conversation with Pamela Tenaerts and Andrew Mackinnon from Medable, alongside hosts Craig Lipset & Amir Kalali.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2022-05-20 We discussed all things reimbursement for clinical trial participants. We covered not only financial compensation but also returning value to participants though sharing data & evidence and more. Our hosts Craig Lipset and Amir Kalali were joined by Adam Samson (Walgreens) Ellyn Getz (CSL Behring), and Wayne Baker (Elite Research Network).

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-07-27 As we approach the halfway mark through 2023, we took a chance to look back at some of our 2023 predictions and share what surprised us, what was cosnsitent, and what is to come for the rest of the years. Members of the DCT Community like Kelly McKee (Medidata), Sarah Canon-McKeown (Langland) came on-stage to share their thoughts with the audience, as well as perspectives from Craig, Amir, and Jane, our hosts.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2022-02-11 Join us to hear about the measurements and endpoints we need to be measuring as we take on DCTs and how we need to modernize those tools to capture the data we need. Our hosts Amir and Craig were joined by Samantha Reed and Andy Coravos (HumanFirst) for the discussion.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-07-14 AI, LLMs, and ChatGPT are all the rage right now - how might they impact DCTs? We'll discuss on Clubhouse tomorrow at 12:00 PM ET. Our hosts wil be joined by Ritesh Patel (FINN Partners) Richie Etwaru (Mobeus) 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.

2023-07-07 Join us as we learn about the regulatory, legal, provacy, and cultural insights for DCTs that are part of DTRAs Global Conduct Map. Our hosts Craig, Amir, and Jane were joined by team members Tom Brazier (mdgroup), Jennifer Turcotte, and Claudine Paccio (DTRA) for the discussion.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2022-02-25 Hosts Craig Lipset and Amir Kalali were joined by Mayank Anand (GSK), Richard Young (Veeva Systems), and Angela Radcliffe (BMS) to discuss data management and integration in clinical trials.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-01-07 As we approach the halfway point of 2023, let's review what we discussed in January as we stepped into the New Year and see what predictions we made and thoughts were shared and evaluate where they stand today. Hosts Craig Lipset, Amir Kalali, and Jane Myles joined for this conversation with some familiar friends in the Clubhouse audience.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-06-23 Now that we've all reviewed the Draft FDA Guidance around DCTs, what would you do if you had a magic wand? If you were the decision maker, how would you take what was offered in the guidance and go further? Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Jonathan Andrus (CRIO) and Dylan Bechtle (The Janssen Pharmaceutical Companies of Johnson & Johnson) for the discussion.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2022-02-18 Join hosts Amir Kalali and Craig Lipset as they discuss the role of Pediatrics in Clinical Trials. Joined by Amir Lahav and Phan Han for the conversation.

2023-05-05 Join us to hear an Association of Clinical Research Professionals (ACRP) debrief with the organization's leadership. Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Susan Landis (ACRP), Elisa Cascade (Advarra), and Adam Samson (Walgreens) to discuss more.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

223-06-10 From the early days of eCOA, as an industry we have set expectations with Ethics committees around what is included in their submission packets for review, namely finalized, localized screenshots. This leads to additional burden for all as we strive to meet submissions dates and hit FPI dates. The advent of the new EU Clinical Trial Regulation provides us with an opportunity to reset that expectation and effectively plan for global research. Paul Taylor and Chris Watson from THREAD Research joined hosts Craig Lipset, Amir Kalali, and Jane Myles 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.

2023-04-21 Join us to hear from DTRA Initiative Leaders Caroline Redeker (Advanced Clinical) and Naveen Goje (ZS) on the great work their team did to gather evidence of impact of DCTs into a data repository to promote education and adoption. Amir Kalali and Jane Myles joined for the conversation.

You can find the full data repository and report here.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-06-02 Join us as we discuss the recently released FDA Draft Guidance on DCTs and its impact on the 1572 Form. Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by DTRA Co Lab Members on this topic, Becky Kottschade (Mayo Clinic) and Shaheen Limbada (Veristat) for the discussion.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-01-27 Join us as we discuss ChatGPT and the place it may have in the decentralized clinical trials space. Our hosts, Craig Lipset, Amir Kalali, and Jane Myles were joined by Joe Dustin (Medable) and Ritesh Patel (FINN Partners) for this riveting conversation.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-01-20 On this episode of TGIF-DCT, our hosts Craig Lipset & Jane Myles were joined by Jon Meyer (Life Sciences Strategy Group) to discuss his research on patient preference. 2/3 of study participants want to see trial have more in-home features and only 9% want fewer. And in-home activities in trials were associated with greater patient satisfaction than those involving travel.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Join hosts Craig Lipset and Amir Kalali as they discuss Patient Choice & Optionality in DCTs. Joined by Michelle Shogren (Innovate in what you do!), Kelly McKee (Medidata), Alexander Pastuszak (Now Contraline, preiously Vault Health), and Angela Radcliffe (BMS).

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

The commitment of pharmacy to address clinical trials has been a recurring topic this week. Craig Lipset was joined by Kendal K. Whitlock, MPH, Head of Digital Optimization, RWE Clinical Trials from Walgreens to discuss the state of the industry, commitment to the field, and progress to-date.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-04-28 TGIF-DCT discussed understanding and addressing site adoption barriers for DCT. Host Craig Lipset, Amir Kalali, and Jane Myles were joined by Michelle Shogren and Sarah McKeown-Cannon to discuss further.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-04-14 What favorite consumer experience should be included in clinical trials? Joe Dustin joined hosts Craig Lipset, Amir Kalali, and Jane Myles for this discussion. Joe's initial LinkedIn post sparked a lot of great interest and response from the Community so we brought it to the stage this week.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-03-24 Join us as we discuss DTRAs Patient Journey Maps for Decentralized Trials and how to use them to improve design and access for your next trial. Hosts Craig Lipset and Jane Myles were joined by Co Leads of the DTRA Initiative Team, Richie Kahn (Canary Advisors, formerly Medable), and Alicia Staley (Medidata Solutions) and Project Manager Deena Bernstein (Datacubed Health) to discuss the great work done at the DTRA to create this dynamic resource. View the Oncology, Vaccines, and Rare Disease journey maps at https://dtraresources.org/

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-03-31 Join hosts Craig Lipset and Jane Myles as they open the floor for an #AMA Ask Me Anything DCT Edition. We welcomed attendees to come to the stage and share their questions and ideas with the audience.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-03-10 This week we discussed the Form 1572 and whether or not it is an obstacle to innovative approaches for improving research access for patients. Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Shaalan Beg (Science 37) and John Campbell (Walgreens) to discuss.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-03-17 Join us to learn how study teams can best navigate the grwing new options of virtual/meta-sites, mobile research sites, retail pharmacy sites, pop-up sites, and more? Hosts Craig Lipset and Jane Myles were joined by Sandeep Bhat (GSK) and Darcy Forman (Science 37) for this conversation.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-03-03 In honor of Rare Disease Day, we discussed Patient Advisory Boards and Decentralized Trials with hosts Craig Lipset and Jane Myles. Our hosts were joined by Alicia Staley (Medidata) and Jen Horonjeff (Savvy Cooperative).

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-02-24 Join us to discuss special considerations for GDPR with eConsent and decentralized trials. Hosts Craig Lipset and Jane Myles were joined by Karen Maduschke (IQVIA) to talk about her recent article, linked here.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-02-17 Join us to discuss whether a community physician can "prescribe" a clinical trial and what the role of decentralized trial tools are to make that happen. Craig Lipset and Jane Myles were joined by Brad Hightower (Hightower Clinical) and Scott Stout (MedVector) to discuss more.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-02-11 We discussed the Best Practices Handbook created by the Initiative Team at DTRA. This team developed a Rubric thst will aid stakeholders in evaluating DCT best practices from program planning to trial close and analysis. Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Mike DeMarco (PwC) and Dan DeBonis (EMA Wellness, formerly Signant Health) to discuss the work their team did to drive this deliverable forward for the community. You can review the Rubric at https://dtraresources.org/rubrics/.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-02-03 Join us to discuss sensors and wearables in clinical trials and what the unmet needs are to execute successfully. We also discussed what it will take to drive meaningful adoption in R&D. Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Megan Parisi and Dr. Luke Koschalka (Syneos Health) to discuss more.

Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Decentralized: The Decentralized Trials & Research Podcast is brought to you by the Decentralized Trials & Research Alliance (DTRA). The Hosts are the DTRA Co Chairs and Co Founders, Craig Lipset and Dr. Amir Kalali.

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 on Friday's at 12:00 PM ET. The replay of those episodes will drop every Monday, with additional episodes being posted from the archives of 2021-2022 along the way.

We encourage you to connect with us on LinkedIn at Decentralized Trials & Research Alliance (DTRA) and on Twitter @DTRAOrg to learn more about the organization.