Past Annual
Meeting Replays

Enable Access: Global Regulatory Perspectives

We kicked off the meeting with a Fireside Chat with Dr. Steffen Thirstrup, Chief Medical Officer of the European Medicines Agency, for a discussion around how the EMA is facilitating clinical trials in the EU and how the 27 member states are working together on coordinating these trials.

Global Adoption of DCTs: What does Access look like?

Global trials are a norm in drug development.  So what does global access look like when DCT elements are used? 
This panel shared experiences to illustrate progress and some challenges in adoption of DCT elements to enable access.  

C3TI Partnership & Collaboration with Community

Meghana Chalasani (FDA) and Kevin Bugin (Amgen) shared with the Community more about the FDA C3TI Center and how organizations can partner, collaborate with them to promote clinical trial innovation and de-risk the use of these methods moving forward.

How DCTs Enable Access, Lessons from the Field

We brought together multiple perspectives - the sponsor, James Donahue, Genentech, the Investigator, Shaalan Beg, Oncologist, NCI, the Reviewer/Policy Maker,Timil Patel, FDA, and the Inspector, Eric Pittman, Director, Bioresearch Monitoring Central at FDA to discuss what have we learned in our adoption and implementation of these methods.

DCT Landscape in Japan

We discussed the progress that has been made towards adoption of decentralized methods and the overall landscape of DCTs in Japan with Kento Asano (Osaka University Hospital), Takateru Inokawa (Buzzreach), Kouta Funakoshi (Kyushu University Hospital), Kenichi Nakamura (National Cancer Center Hospital), Shinya Yamamoto (Osaka University, Tohoku University) and Aoyagi Kiyoshi (Buzzreach).

Cross Partner Collaborations in Site Voice

Access for all can’t happen without collaboration across all the different parts of the clinical trial ecosystem. We made the case that innovation is not as efficient or effective without that collaboration. Jane Myles (DTRA) was joined by Amber Spierer (TransCelerate) and Deena Bernstein (on behalf of SCRS) for the discussion.

Bring Your Own Technology for Sites

Sites are overwhelmed by the increasing number and complexity of technology solutions used in clinical trials. Joe Dustin (eClinical Consulting), Brandon Maggio (GSK), and Rick Greenfield (Real-Time CTMS Solutions) took the stage to share how they are creating a pathway to make it possible for sites to use their preferred technology.

Site Adoption Town Hall

Leaders from the three CoLab Teams took the stage to address questions from the audience around our work in Site Adoption.

How can generative AI contribute to DCT design?

Derk Arts (Castor), Melissa Ceroulo (Medidata), Annie Saha (FDA), and
Toke Folke Christensen (Novo Nordisk) took the stage to discuss risks with generative AI, workflow simplification, and regulatory current and future state.

Supporting DHT Adoption: Aligning on Needs and Solutions

Lauren Tobe (Lilly) and Annie Saha (FDA) discussed the adoption of Digital Health Technologies (DHTs) in clinical trials. This session explored key survey insights, regulatory expectations, and the path to more predictable evidence packages.

Roles & Responsibilities through the Site Lens

Who does what in decentralized trials? We set out to break it down by clarifying tasks and reducing ambiguity during trial planning. Caroline Redeker (Advanced Clinical) and Rebecca Kottschade (Mayo Clinic) took the stage to share more about why we did this work and facilitated a workshop to get feedback from the audience.

Fireside Chat with the FDA

M Khair ElZarrad, MD (FDA) joined Craig Lipset for a discussion around key takeaways from the DCT guidance, the new RCT-in-routine-care framework, and how digital and data fit into trials.

Participant Access through Local Communities

Our meeting theme was Access for all, and we explored how DCTs can support that access through community settings with Alexa Richie (Optum), Amanda Wagner Gee (Milken-EnrichCT), Bernadette Tosti (Flatiron) and Petros Okubagzi, MD (MedStar).

Measuring Impact of DCT Methods

Panelists explored key tactics for assessing effectiveness, emerging trends and insights from collected data, and how organizations are leveraging these findings. Hear more from Brandon Maggio (GSK), Zak Smith (Tufts), Timil Patel (FDA), and Christoph Hornik (Duke)

Interactive Town Hall

Amir Kalali, Craig Lipset, and Jane Myles took the stage to answer live Q&A around DCTs and HCP, Diversity Realities, Delivering DCT
and Maintaining Progress

Unlocking the Power of AI and Sensors in Clinical Trials

Melissa Ceruolo from Medidata spoke from the stage about Medidata's work with sensors and AI in Clinical Trials.

Mayo Clinic: Clinical Trials Beyond Walls Initiative

Becky Kottschade and Justin Gundelach from Mayo Clinic took the stage to share an update on their work at Mayo Clinic around decentralized trials.

IMI Trials@Home Update

Shelly Barnes from UBC took the stage to share more about the work of IMI Trials@Home and the RADIAL trial.

GSK + Medable Partnership

Panelists explored key tactics for assessing effectiveness, emerging trends and insights from collected data, and how organizations are leveraging these findings. Hear more from Brandon Maggio (GSK), Zak Smith (Tufts), Timil Patel (FDA), and Christoph Hornik (Duke)

The Future of Clinical Trials: Data-driven Insights into Decentralized Solutions Offering Accessibility for Everyone

Zak Smith from Tufts joined us to shared more about their work and data around DCT offerings.

Medable - Demo Theater

Andrew Mackinnon and Arzu Arkturan from Medable took the stage to share more about the Medable Studio product.