In the Spotlight
JOIN US! MRCT Center 2025 Annual Symposium
Join us for a full day of discussions and presentations on ethical, actionable, and practical solutions to today’s global clinical research challenges. Engage with regulators, industry leaders, patient advocates, and research experts to gain privileged insights, shape the conversation, and forge connections that drive real-world impact. The symposium is free and open to all registrants.
We are pleased to announce our keynote speaker: John Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), a biotechnology advocacy organization representing biotech companies, industry leaders, and state biotech associations in the United States and more than 35 countries around the globe. John’s decades of biotech experience and deep passion for the field have made him a strong supporter of policies that empower innovation, enable entrepreneurship, and put people and patients first.
Other highlights of the agenda include the following:
- Rethinking Informed Consent with Artificial Intelligence: Opportunities and Challenges
- Cell and Gene Therapies Long-Term Follow-Up: Key Deliverables and the Path Forward
- Reinventing Informed Consent: Emerging from the Chrysalis
- Clinical Trial Reform: The Need for Change and Progress
On Thursday morning, October 23, the MRCT Center will hold a joint meeting in concert with the Vivli annual meeting. Researchers, data contributors, and funders will discuss the journey from data contribution to impact in clinical trial methodology, oncology, and Type 1 diabetes. Sessions will focus on learnings from data challenges, the latest in sharing imaging data, as well as how to apply the latest DOJ ruling on sharing data with countries of concern. This event is also complimentary and open to all Symposium registrants.
Register today to secure your spot and help drive responsible innovation in clinical trials.
The Clinical Research Glossary: Now Expanded to 216 Words
The MRCT Center’s Clinical Research Glossary helps participants, patients, and care partners make informed decisions about clinical research by explaining complex terms in clear, plain language. Everyone—regardless of background—has the right to understand, ask questions, and fully engage in the research process. The glossary also supports research professionals in fostering clear, meaningful dialogue with participants throughout a study.
In collaboration with CDISC, we’ve added 29 new terms. The glossary now includes 216 terms, definitions, images, and related content, and is freely accessible under a Creative Commons license. Click here for an updated FAQ with a Summary of Changes.
Explore, download, and share the glossary—and help make clinical research clearer for all. Submit feedback or suggest additional terms here.
Upcoming Webinars
October 30, 12:00 PM – 1:00 PM ET: Applied Health Literacy: Using Teach-Back in Clinical Research
October is Health Literacy Month! Join us on Thursday, October 30, from 12 – 1 PM ET for the webinar Applied Health Literacy: Using Teach-Back in Conversations About Clinical Research.
Learn the essential elements of Teach-Back, why it matters for safe, equitable care and research, and practical ways to integrate it into clinical research conversations. The session will highlight how study teams can simplify complex information, confirm understanding, and foster dialogue with participants and caregivers throughout recruitment, consent, and beyond.
Registrants will receive tips and resources to apply TB in everyday research processes.
November 4, 11:00 AM – 12:00 PM ET: Long-Term Follow-Up for Gene Therapies: Toolkit Release
Long-term follow-up (LTFU) studies are essential to assess the benefit–risk profile of gene therapies. Yet they are difficult to design and carry out, placing burdens on both participants and sponsors.
In September 2024, the MRCT Center convened a working group on LTFU studies for gene therapies. The group includes patients and representatives from pharmaceutical companies, clinical research organizations, academic medical centers, institutional review board oversight, and patient advocacy organizations.
This webinar will introduce a Toolkit for Supporting the Design and Conduct of Long-Term Follow-Up Studies for Gene Therapies, which is being released as a draft for public comment. Members of the working group will share their perspectives on the Toolkit’s development and discuss next steps. The session will conclude with audience questions and discussion.
Events & Presentations
September 8: Meeting of the Bioethics Collaborative. Topic: Ethics of Rare Diseases. For more information about the Bioethics Collaborative and how to join, click here.
September 9: The MRCT Center and Vivli co-facilitated an invite-only forum, “From Policy to Practice: Implementing the European Health Data Space (EHDS) for Responsible Data Sharing.” International representatives fielded questions related to EHDS challenges, areas of uncertainty, or provisions that remain unclear.
September 12: Continued Access to Investigational Products: Guiding Equitable and Fair Decisions: This webinar, now available on demand, explored the MRCT Center’s work to address the challenges of post-trial, continued access, emphasizing that planning for the continued provision of investigational medicines or devices must begin before a trial starts. It highlighted principles and frameworks developed by the Post-Trial Continued Access Task Force, including a case study on difficult decisions when a trial’s primary endpoint fails but a subpopulation benefits.
September 14: Barbara Bierer presented a lecture on “Optimizing Representation in Clinical Research in an Interconnected, Global World” at the Second International Conference of the Japanese Association for Philosophical and Ethical Research in Medicine (JAPERM), held at Kanagawa University in Yokohama, Japan.
September 16: Barbara Bierer presented two talks, “Training and Professional Development of Research and Ethics Professionals” and “Patient and Public Involvement (PPI) in Advanced Cell and Regenerative Therapies,” to members of the RIKEN Institute, the premier Japanese research organization, and Osaka University.
September 22: Sarah White and Carmen Aldinger, along with Rebecca Li and Julie Wood of Vivli, hosted the 2025 Mansfield-PhRMA Research Scholars in Boston. Presentations related to the work of the MRCT Center and Vivli were provided to the scholars.
September 25: Willyanne DeCormier Plosky led a discussion of the article “Excluding People With Disabilities From Clinical Research: Eligibility Criteria Lack Clarity And Justification | Health Affairs” at the most recent MGB Disability Employee Inclusion Alliance lunch-and-learn session.
September 25: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topic: China Revisited: Recent Developments Affecting Research Involving the People’s Republic of China (“PRC”). For more information about R3 and how to join, click here.
September 26-28: Barbara Bierer opened this year’s Society for Clinical Research Associates (SOCRA) conference in Chicago, IL, participating in the opening plenary panel entitled, “Research Advocacy Under a New Administration: Insights and Actions.” Sylvia Baedorf Kassis delivered the closing plenary address, focusing on strategies for prioritizing conference takeaways, lessons learned, and new resources to increase impact.
September 30: AI Digital Twins and Synthetic Data: Applications to Clinical Trials. On-demand webinar resources will be posted to the MRCT Center website soon.
September 30: The MRCT Center and Vivli co-host an ongoing, invite-only forum focused on the European Health Data Space (EHDS), bringing together stakeholders to track developments and coordinate responses. This convening, the fourth in the series to date, will prioritize upcoming TEHDAS2 guidance documents for public consultation and develop a strategy for collective feedback and submissions.
October 22, 8:00 – 5:00 PM ET: MRCT Center Annual Symposium. See spotlight above for details.
October 23: 8:30 – 3:30 PM ET: Vivli Annual Meeting, co-hosted with the MRCT Center. “Data in Action: From Contribution to Impact.” See Spotlight above for details.
October 24, 2:30-3:30 pm: Trevor Baker and Barbara Bierer will be joined by Donna Snyder (WCG) to present, “Review Framework for Clinical Research involving AI” at the MAGI@ home Boston conference.
November 4, 11:00 AM – 12:00 PM ET: Long-Term Follow-Up for Gene Therapies: Toolkit Release Webinar. See Spotlight above.
November 8: Willyanne DeCormier Plosky will speak, with co-panelists Tiffany Chenneville (University of South Florida) and Cheri Pettey (Advarra), at the PRIM&R 2025 Conference Lunch Networking Session, “Science Under Siege: Defending Scientific Integrity in a Politicized World.”
Nov 14: Sylvia Baedorf Kassis has been invited to speak at the International Society for Medical Publication Professionals (ISMPP) Academy.
Publications
September 18: The MRCT Center submitted public comments on the draft ICH E21 guidance regarding the inclusion of pregnant and breastfeeding women in clinical trials. The MRCT Center strongly supports the ethical inclusion of these historically understudied populations and emphasized the need for ethical and rigorous, well-designed research guided by participant and individual protections.
The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.
Learn more about becoming an MRCT Center sponsor.