The MRCT Center Podcast

Episode Overview: In this fifth episode of the MRCT Center podcast, Dr. Barbara Bierer, Faculty Director of the MRCT Center and professor of medicine at BWH and HMS, discusses the newly released Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up (LTFU) Studies for Gene Therapies with Carolyn Chapman, Leader of the Cell and Gene therapies project at the MRCT Center, Lead Investigator at BWH and member of the faculty at HMS. Key Discussion Topics: What are Long-Term Follow-up studies for gene therapies and why are they needed Who the LTFU toolkit designed for The development of the toolkit through diverse collaboration The timeliness and importance of this toolkit release A comprehensive walk-through of the sections and features of the toolkit What the porridge is the "Goldilocks issue"? In depth discussion on what it means for a patient to be part of a LTFU study and how to address the potential burdens Learn More: Access the full LTFU Toolkit and additional standalone resources at: mrctcenter.org/LTFUToolkit Subscribe & Share: If you value practical, ethical, and globally relevant conversations about clinical research, subscribe to the MRCT Center podcast. Share this episode, follow us on LinkedIn and YouTube, and visit mrctcenter.org to explore more.

Trials Beyond Borders: Clinical Trials in Latin America—Aligning Global Research with Local Realities In this episode, Dr. Carla Saenz, Regional Advisor for Bioethics at the Pan American Health Organization (PAHO), joins Willyanne DeCormier Plosky, Program Director at the MRCT Center, for a compelling conversation on the clinical trial landscape in Latin America. Together, they explore: How population demographics, different hospital systems, and insurance models influence trial participation and representation Ethical and regulatory pathways to increase inclusion in research The role of international guidance, including the CIOMS guidelines, in shaping ethical trial conduct Opportunities to design global trials that reflect and respect local contexts—without compromising scientific rigor This discussion underscores the importance of equitable access and locally relevant research in an increasingly global clinical trial ecosystem. For more about the MRCT Center’s work on Global Representation in Clinical Trials, click here or go to https://mrctcenter.org/representation-in-research/global_dei/.

Episode Overview: In this special episode, recorded during the MRCT Center’s October 2024 conference, Advancing Pediatric Platform Trials: Streamlining Development, Maximizing Impact, we feature a keynote conversation with Dr. Danny Benjamin—renowned pediatrician, researcher, and champion of clinical trial innovation. Dr. Benjamin discusses how platform trials can address persistent gaps in pediatric therapeutic development and why a coordinated, multi-stakeholder approach is critical to success. His insights, drawn from decades of leadership in this space, speak directly to the opportunities and operational challenges detailed in the MRCT Center’s post-conference report. Key Discussion Topics: Why traditional clinical trial models often fail pediatric populations The case for multi-arm, multi-sponsor platform trials in rare and common childhood conditions Governance and operational infrastructure to support long-term trial viability Lessons learned from the Pediatric Trials Network and other collaborative efforts The importance of global alignment, data sharing, and ethical considerations in trial design Learn More: Explore the full Executive and Full Reports from the October convening: 🔗 Advancing Pediatric Platform Trials: Streamlining Development, Maximizing Impact About the Guest: Dr. Danny Benjamin is the Kiser-Arena Distinguished Professor of Pediatrics at Duke University and a national leader in pediatric drug development. He serves as Principal Investigator of the Pediatric Trials Network and has been instrumental in shaping evidence-based approaches to clinical research in children. Subscribe & Share: If you value practical, ethical, and globally relevant conversations about clinical research, subscribe to the MRCT Center podcast. Share this episode with colleagues and visit mrctcenter.org to explore more.

In this episode, Racquel Bruton, Associate Director and Clinical Trials Diversity Portfolio Lead at Biogen, and Willyanne DeCormier Plosky, Program Director at the MRCT Center, discuss how sponsor companies are enhancing representation in clinical trials, particularly outside the US. Racquel highlights Biogen's longstanding commitment to reaching underrepresented populations and explores how the MRCT Center’s roadmap can help organizations develop effective diversity action plans. Resources: Representation in Research/Global Populations https://mrctcenter.org/representation-in-research/global_dei/ Global Representation Roadmap https://mrctcenter.org/resource/global-representation-roadmap/

This is the first episode in our new series, "Trials Beyond Borders: Building Representative Clinical Trials Worldwide."  This episode features a conversation with MRCT Center Program Director Willyanne DeCormier Plosky, consultant Katherine Wright, and Tinaya Gray, Global Head of Diversity in Clinical Trials at ICON, plc, about the CRO perspective, focusing on communication between sponsors, CROs, and sites in planning for diversity action plans in the context of global trials.