Decentralized: The Decentralized Trials & Research Podcast

Recruitment: The more things change, the more they stay the same?

Mon, 13 Apr 2026 09:15:00 -0400

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. Paul also shared perspectives on study branding, the limits of recruitment technology and registries, and the role of trust in patient participation.

We also discussed strategies for engaging underrepresented physicians and improving access to clinical research.

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 options and our work at www.dtra.org.

Building Bridges: How One Team Is Connecting Innovation to Practice

Mon, 23 Mar 2026 09:00:00 -0400

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 management, starting with open-minded teams, securing leadership support, and using real-world examples to drive adoption. The conversation highlights the importance of starting small, maintaining momentum, and enabling success through clear communication, accessible resources, and collaboration with partners like DTRA.

Selective Safety Data Collection: When "Less" Is Better

Mon, 23 Feb 2026 09:00:00 -0400

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 ICH E19, allows for a planned reduction in low-value safety data while maintaining robust monitoring of serious adverse events and other critical outcomes. The panel addressed common misconceptions, emphasizing that SSDC does not lower safety standards or eliminate oversight, it simply focuses on collecting data that meaningfully informs the risk-benefit profile.

Meghana Chalasani also highlighted FDA’s C3TI demonstration program and other innovative approaches like Bayesian methods and streamlined trials embedded in clinical practice. The discussion closed with practical site-level considerations, including how to integrate SSDC into existing workflows while maintaining consistency and regulatory alignment. Overall, the conversation underscored a shift toward smarter, more efficient trial design without compromising patient safety.

Pioneering DCTs - A Community Approach

Mon, 08 Dec 2025 09:00:00 -0400

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 practices in running complex trials.

The conversation covers real-world strategies for patient activation, managing variability across sites, partnering with CROs, and enabling rural and community-based providers to participate in research. They also touched on the future: global expansion plans and how DCT approaches could extend beyond oncology into other therapeutic areas.

Why People Stay (Or Don't)/ Rethinking Participation in Modern Trials

Mon, 17 Nov 2025 09:00:00 -0400

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 include the importance of strong site support, clearer communication, caregiver involvement, and the operational challenges that trial sites face.

The group also explores broader issues in patient engagement—from protocol design and long-term communication gaps to the role AI could play in improving support and retention.

The Participation Equation: a webinar from Cuttsy+Cuttsy and ISPEP

Link to sign up for the webinar on 11/19 at 9:00 AM ET

The participation equation: Understanding what drives participant engagement in clinical trials

Link to access the report here

AI, Apps and Audits: The new Compliance Chaos in Clinical Research

Mon, 27 Oct 2025 09:00:00 -0400

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 laws
The tension between innovation and compliance in decentralized trials
The importance of clear regulatory guidance in the evolving AI landscape
How contractual and ethical frameworks can safeguard both sponsors and sites

Transcelerate's Sponsor Considerations for Obtaining Site Feedback

Mon, 06 Oct 2025 09:00:00 -0400

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 site feedback to improve decentralized clinical trial (DCT) implementation. We discussed the importance of patient, site, and sponsor feedback in shaping trial design, and touch on other relevant resources that support more patient-centric, flexible, and resilient approaches. Hear from Laura Renton (GSK) and Anna Christiansson (AstraZeneca) in this practical discussion on these resources and how you can begin to apply them in your organization.

Modernizing Clinical Trial Conduct Solutions Toolkit

Digital Therapeutics in Decentralized Trials

Mon, 15 Sep 2025 09:00:00 -0400

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 rheumatology and beyond. Our guests explored the challenges of patient engagement, onboarding, and adherence, and shared lessons learned from real-world implementations of digital tools in trials. We also discussed innovations in patient monitoring for inflammatory arthritis, Switzerland’s approach to scaling digital health, and opportunities for collaboration across healthcare systems.

Link to Paper -- https://journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000905

Home visits for Rare Disease Research

Mon, 25 Aug 2025 09:00:00 -0400

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 rare disease families—from challenges in home healthcare and nurse training to the promise of digital health tools and decentralized approaches. Alpa highlights how Gooseberry Research is working to improve trial accessibility through specialized nurse training, stronger site communication, and partnerships with technology providers.

The episode also touches on trial design hurdles, the need for meaningful endpoints, and the future of decentralized clinical trials.

Episode Resources:

DCT Market Trend

Research About a Novel, Home-Based Assessment for Duchenne Muscular Dystrophy

A Pathway to use Site-Selected Technology in Clinical Trials

Mon, 04 Aug 2025 15:00:00 -0400

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 how this approach streamlines workflows, improves data quality, and puts sites and patients first.

BYOT Playbook -- https://www.dtra.org/bring-your-own-technology

Including HCPs in Clinical Trials

Tue, 22 Jul 2025 18:00:00 -0400

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 clinical research. Using HCPs in trials can provide greater access for all patients, as well as continuing to build trust in research with providers.

You can join TGIF-DTRA Sessions 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 options and our work at www.dtra.org.

DIA Roundup

Mon, 30 Jun 2025 16:00:00 -0400

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.

The Power of Site Networks in Innovation

Mon, 16 Jun 2025 14:00:00 -0400

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.

Trial By Experience: Living both sides of Clinical Research

Mon, 19 May 2025 09:00:00 -0400

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 experiences. Our hosts Craig Lipset and Jane Myles were joined by Alicia Staley, Craig Serra, and Terttu Haring to share their experiences.

From Idea to Digital Measurement via DCT

Fri, 09 May 2025 12:00:00 -0400

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.

Navigating US Regulatory Change in an unpredictable environment

Mon, 28 Apr 2025 09:00:00 -0400

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 industry, and the evolving policies at the FDA, including the concept of an intermediate clinical endpoint and the interpretation and mapping of these concepts. The team also discussed the potential changes in the FDA's organizational structure, its impact on the agency's role in international collaborations, and the need for a balance between safety and efficacy in drug development.

Resources:

Navigating the ICH E6 R3 with tools & solutions

Mon, 14 Apr 2025 09:00:00 -0400

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 worked on to help better support trial planning and design.

The tools can be found online at the following websites:

Transcelerate ICH E6 Asset Library -- https://www.transceleratebiopharmainc.com/assets/ich-e6-asset-library/

Transcelerate ICH E6 R3 Tools & Resources Webinar -- https://www.youtube.com/watch?v=W-6vM6hOLcU&feature=youtu.be

ACRO Interpreting ICH E6 R3 -- https://www.acrohealth.org/initiatives-hub/interpreting-ich-e6r3/

Bringing Community Oncologists into Trials

Mon, 07 Apr 2025 09:00:00 -0400

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 building partnerships with local healthcare providers, and the potential benefits of working with these providers.

Episode Resources:

You can join TGIF-DTRA Sessions live on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn to see what sessions are coming next and get the link to join. Learn more about Membership options and our work at www.dtra.org.

Patient Experience Ratings & Decentralized Trials

Fri, 21 Mar 2025 11:45:00 -0400

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.

A Patient Perspective on the DCT Field

Fri, 07 Mar 2025 12:00:00 -0400

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.

Breaking Barriers in Tech Adoption & AI

Mon, 03 Mar 2025 09:00:00 -0400

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 more

SCOPE Summit 2025 Recap

Mon, 10 Feb 2025 09:00:00 -0400

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.

From Chaos to Clarity: Defining Who Does What?

Mon, 03 Feb 2025 09:00:00 -0400

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 trials evolve. It is often unclear to sites whose responsibility it is to do what when using DCT methods. Site considerations for implementation of DCTs include training, ongoing support, cost, risk, responsibility, logistics, integrations, and teaching patients how to use and enable the DCT offerings. This team developed a set of questions to be applied before site selection and at site activation to aid in study planning.

The newly released work is now available on the DTRA website at: https://www.dtra.org/roles-and-responsibilities-colab

Demystifying eConsent - The European Forum GCP eConsent Suite of Tools

Thu, 30 Jan 2025 15:00:00 -0400

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 resources, tools, articles, and more here --> https://efgcp.eu/project?initiative=eConsent

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

Mon, 20 Jan 2025 09:00:00 -0400

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.

2024 in Review

Mon, 06 Jan 2025 09:00:00 -0400

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

Investigating Data Quality in Hybrid Clinical Studies

Mon, 09 Dec 2024 09:00:00 -0400

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.

Increasing Adoption of Wearables in Clinical Trials

Mon, 25 Nov 2024 09:00:00 -0400

2024-11-22 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Keith Robinson, MD, MS, FCCP and Megan Parisi, MS, CCRP from Syneos Health and Nick Delmonico from Strados Labs for a discussion around wearables. We discussed challenges in increasing adoption of wearables, factors that are holding things back from greater widespread adoption, and the benefits/ROI of wearables and novel measurements.

Unlocking the Potential of Clinical Trial Data: New CRDSA Standards

Mon, 04 Nov 2024 09:00:00 -0400

2024-10-31 Clinical Research Data Sharing Alliance (CRDSA) published two new standards earlier this year: the Standard for Sharing Clinical Study Data and the Standard for Secondary Analysis of Clinical Study Data.

We held a great discussion on how these standards aim to facilitate the responsible sharing and use of anonymized individual patient data from clinical studies to support the research community and accelerate the discovery and delivery of new therapies to patients.

Data Reuse in Regulatory Submissions: The Role of Data Platforms resource was discussed during the live session as well.

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

Tue, 15 Oct 2024 09:00:00 -0400

2024-10-10 Hosts Craig Lipset, Dr. Amir Kalali, and Jane Myles were joined by Matt Veatch and Aaron Kamauu, hosts of the Real World Wednesday's Club on Clubhouse. We joined forces for a TGIF-DTRA + RWW Crossover Episode!

With the release of the FDA Draft Guidance on Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice, it was the perfect topic to bring together the DCT and RWE community for a conversation around this guidance. We discussed why this guidance was aligned to RWE, the distinctions between decentralized, pragmatic, point-of-care trials, and real-world evidence, and how RCTs and DCTs can drive access for all patients.

Read the guidance here --> https://www.fda.gov/media/181871/download

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

Mon, 14 Oct 2024 09:00:00 -0400

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.

Protocol Changes - Covid and Beyond

Mon, 07 Oct 2024 09:00:00 -0400

2024-10-04 Hosts Jane Myles and special guest host Jean Sposaro (BMS) welcomed Joe Unger (Fred Hutch) for a conversation. The COVID-19 pandemic significantly decreased cancer clinical trial enrollment and swift changes were needed from researchers, regulators, and policymakers to ensure research and care could continue. He shares more about a task force created to better understand the impact of the pandemic on the conduct of oncology clinical trials.

Conducting Clinical Trials with DCT Elements Guidance

Mon, 23 Sep 2024 09:00:00 -0400

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!

DCT Adoption in Covid and Beyond

Mon, 16 Sep 2024 09:00:00 -0400

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-toe

Recruitment & Retention through Innovation

Mon, 09 Sep 2024 09:00:00 -0400

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.

Inspection Readiness for Decentralized Trials

Fri, 23 Aug 2024 11:30:00 -0400

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.

Decentralized Clinical Trials in the Trial Innovation Network

Mon, 29 Jul 2024 09:00:00 -0400

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/

Patient Centricity by Design

Mon, 22 Jul 2024 09:00:00 -0400

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.

Navigating eConsent Implementation Chaos

Mon, 15 Jul 2024 09:00:00 -0400

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.

Building Clinical Trial and Health Research Access via Community Health Centers

Mon, 01 Jul 2024 09:00:00 -0400

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/#researchdiversitywhitepaper

FDA Inspection of a Decentralized Meta-Site

Mon, 24 Jun 2024 09:00:00 -0400

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.

Data Diversity, Data Access, and Rights

Mon, 17 Jun 2024 09:00:00 -0400

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.

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

Wed, 12 Jun 2024 11:00:00 -0400

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

Sponsor Experience Implementing DCTs

Mon, 10 Jun 2024 09:00:00 -0400

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

TGIF-DTRA Ask Us Anything DCT Edition

Wed, 05 Jun 2024 14:15:00 -0400

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.

RBQM and Decentralized Trials

Fri, 24 May 2024 12:00:00 -0400

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.

Let's Celebrate Clinical Trials Day!

Mon, 20 May 2024 09:00:00 -0400

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.

Driving Oncology Trials to the Community

Mon, 13 May 2024 09:00:00 -0400

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.

Unlocking Digital Health Tech in Clinical Trials

Mon, 06 May 2024 14:00:00 -0400

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

Mon, 06 May 2024 14:00:00 -0400

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.

Site Needs for Decentralized Trials

Mon, 22 Apr 2024 12:00:00 -0400

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.

Novel Platform & DCTs Drive Innovation

Mon, 15 Apr 2024 09:00:00 -0400

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.

What Evidence do you need for DCTs and how to find it?

Mon, 08 Apr 2024 09:00:00 -0400

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.

Clinical Trial Matching Solutions: Is it Solved?

Tue, 02 Apr 2024 11:00:00 -0400

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?

Mon, 25 Mar 2024 09:00:00 -0400

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.

Growing Enthusiasm for DCTs in Pakistan

Mon, 18 Mar 2024 14:00:00 -0400

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

Fri, 08 Mar 2024 10:15:00 -0400

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

Mon, 04 Mar 2024 09:00:00 -0400

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

Mon, 26 Feb 2024 09:00:00 -0400

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

Mon, 19 Feb 2024 09:00:00 -0400

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.

CRAFT Hybrid DCT Model Strategy

Mon, 12 Feb 2024 09:00:00 -0400

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.

Mergers & Acquisitions in DCT

Mon, 05 Feb 2024 09:00:00 -0400

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

Mon, 29 Jan 2024 09:00:00 -0400

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.

AI & Clinical Trial Efficiency

Mon, 22 Jan 2024 09:00:00 -0400

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.

AI in Clinical Trials & Care

Wed, 17 Jan 2024 15:00:00 -0400

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

Mon, 08 Jan 2024 09:00:00 -0400

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.

Holistic Patient Support in Decentralized Trials

Fri, 29 Dec 2023 12:00:00 -0400

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.

Do Decentralized Trials Really Impact Diversity?

Fri, 22 Dec 2023 12:00:00 -0400

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 Decentralized Trials Wrap Up

Thu, 21 Dec 2023 16:30:00 -0400

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?

Mon, 11 Dec 2023 09:00:00 -0400

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

Mon, 04 Dec 2023 09:00:00 -0400

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

Fri, 24 Nov 2023 12:00:00 -0400

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"

Fri, 10 Nov 2023 12:00:00 -0400

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

Mon, 06 Nov 2023 09:00:00 -0400

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.

TGIF-DCT: MRCT/Medable IRB/Ethics Taskforce in DCT recommendations

Mon, 30 Oct 2023 09:00:00 -0400

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.

Adoption of DCT approaches by PIs and Site Staff

Mon, 23 Oct 2023 09:00:00 -0400

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.

Real World Data & DCTs

Mon, 16 Oct 2023 09:00:00 -0400

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.

DCTs and Traditional Sites: Friend or Foe?

Fri, 06 Oct 2023 09:00:00 -0400

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)

Data on our Terms: The Key to Patient Empowerment

Wed, 04 Oct 2023 09:00:00 -0400

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.

REMOTE Tech on the Range: Enabling DCTs in Rural & Frontier Settings

Mon, 02 Oct 2023 10:30:00 -0400

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.

Data from the Field: DCT Participant Experience

Mon, 25 Sep 2023 09:00:00 -0400

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.

DTRA Circles Round Up

Mon, 11 Sep 2023 09:00:00 -0400

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.

Partnering PI Networks + DCT Platforms

Fri, 01 Sep 2023 09:00:00 -0400

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.

Can Patients Bring Their EHR Data into DCTs Today?

Fri, 25 Aug 2023 12:00:00 -0400

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.

Wearables in Decentralized Trials

Fri, 18 Aug 2023 12:00:00 -0400

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.

What is the Financial ROI for Decentralized Trials?

Fri, 11 Aug 2023 12:00:00 -0400

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.

Participant Value & Reimbursement in DCTs

Fri, 04 Aug 2023 12:00:00 -0400

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.

Mid-Year 2023 Recap on all things DCT

Mon, 31 Jul 2023 14:00:00 -0400

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.

Digital Measurement & Decentralized Trials

Wed, 19 Jul 2023 09:00:00 -0400

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.

AI, LLMs, ChatGPT, & DCT

Tue, 18 Jul 2023 09:00:00 -0400

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.

Global Conduct Map for DCTs

Mon, 10 Jul 2023 11:00:00 -0400

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.

Data Integrations and Decentralized Trials

Fri, 30 Jun 2023 09:00:00 -0400

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.

A Look Back on our Look Ahead at DCT in '23

Wed, 28 Jun 2023 09:00:00 -0400

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.

Draft FDA Guidance & a Magic Wand

Mon, 26 Jun 2023 09:00:00 -0400

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.

Kids and Decentralized Trials

Tue, 20 Jun 2023 09:00:00 -0400

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.

DCT Insights from ACRP Annual Meeting

Thu, 15 Jun 2023 09:00:00 -0400

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.

IRB Submissions & EU Clinical Trials Submissions

Wed, 14 Jun 2023 11:00:00 -0400

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.

Evidence of Impact in Decentralized Trials

Wed, 07 Jun 2023 13:00:00 -0400

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.

1572s & Draft DCT Guidance

Tue, 06 Jun 2023 09:00:00 -0400

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.

New Research on Patient Preference in Clinical Trial Participation

Wed, 31 May 2023 09:00:00 -0400

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.

ChatGPT Meets DCT

Wed, 31 May 2023 09:00:00 -0400

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.

Patient Optionality & Choice in DCTs

Fri, 26 May 2023 09:00:00 -0400

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.

Walgreens and the Commitment to Trials

Tue, 23 May 2023 09:00:00 -0400

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.

Addressing Site DCT Adoption Barrier

Mon, 08 May 2023 09:00:00 -0400

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.

What Consumer Experience do you wish for Clinical Trials?

Fri, 05 May 2023 09:00:00 -0400

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.

Unmet Needs for Sensors an Wearables in DCTs

Thu, 04 May 2023 09:00:00 -0400

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.

A Best Practice Handbook for DCTs

Thu, 04 May 2023 09:00:00 -0400

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.

Can Decentralized Tools enable a Physician to "Prescribe" a Clinical Trial?

Thu, 04 May 2023 09:00:00 -0400

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.

Privacy eConsent: GDPR and Other Global Consent Considerations

Thu, 04 May 2023 09:00:00 -0400

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.

Rare Disease Day: Patient Advisory Boards and Clinical Trials

Thu, 04 May 2023 09:00:00 -0400

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.

Is the "1572" Slowing Innovation to Improve Trial Access?

Thu, 04 May 2023 09:00:00 -0400

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.

New Alternative Site Models for Clinical Trials

Thu, 04 May 2023 09:00:00 -0400

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.

Patient Journey Maps for Decentralized Trials

Thu, 04 May 2023 09:00:00 -0400

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.

#AskMeAnything DCT Edition

Thu, 04 May 2023 09:00:00 -0400

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.

Welcome to Decentralized: The Decentralized Trials & Research Podcast

Wed, 05 Apr 2023 09:00:00 -0400

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.