Save the Date: MRCT Center 2026 Annual Symposium
The MRCT Center 2026 Annual Symposium returns to Boston on Wednesday, October 21, 2026, to be held at the offices of Ropes & Gray in Boston. Join us for a full day of discussions and presentations on ethical, actionable, and practical solutions to today’s global clinical research challenges.
On Thursday, October 22, the MRCT Center leads a day dedicated to data sharing, co-organized with Vivli.
The symposium is hybrid, in-person in Boston, and online, and it is free and open to all. Registration is now open. Attend one day or both, in person or virtually. The keynote and full agenda will be announced in the coming weeks.
Register today to secure your spot and help drive responsible innovation in clinical trials.
Related:
AI in the Operations and Administration of Clinical Trials will be featured at the 2026 MRCT Center Annual Symposium.
As part of this effort, we request individuals and organizations to share pilots, tools, and/or technical solutions. Please contact Trevor Baker (tbaker13@bwh.harvard.edu) if you have or know of such solutions. In addition, please feel free to introduce us to others you know, or let us know of others to whom we should reach out.
TRACE Project: Strengthening Clinical Trial Ethics Across Africa: Core Team Meeting in Zimbabwe
The MRCT Center serves as technical lead for the TRACE (Trial Regulatory and Clinical Ethics Optimization) project, a partnership working to strengthen clinical trial ethics capacity across Sub-Saharan Africa. Work with Nigeria, Rwanda, Zimbabwe, and Tanzania expanded in 2026 to include Kenya. The Center supports each country’s distinct needs in capacity building and financial sustainability, with particular attention to parallel submission, registration, accreditation pathways, in-country reliance, and sustainable financing models.
In early June, the TRACE core team convened in Harare, Zimbabwe, hosted by the Medicines Control Authority of Zimbabwe (MCAZ), with opening remarks from MCAZ leadership and the Gates Foundation and a keynote from Dr. Aspect Jacob Vengani (AJV) Maunganidze, Zimbabwe’s Permanent Secretary for the Ministry of Health and Child Care. Over four days, all five countries reported progress against project milestones and worked through the practical challenges of strengthening national ethics oversight: shortening protocol review timelines, advancing accreditation and in-country reliance models, and building toward financial sustainability. Each country left Harare with concrete commitments and timelines for the months ahead, with continued technical support from the MRCT Center. The meeting reaffirmed the Center’s role as technical lead and coordinating partner across the five-country partnership.
Read the full report from Harare.
Childhood Cancer Academic-Industry Collaborative Platform Trials (C3PT): Toolkit Launch Webinar
Tuesday, September 22, 2026, 10:00 to 11:00 AM ET
The MRCT Center, in collaboration with ITCC (Innovative Therapies for Children and Adolescents with Cancer), Blood Cancer United, and the Children’s Oncology Group, will launch the Childhood Cancer Academic-Industry Collaborative Platform Trials (C3PT) Position Narrative and Toolkit, guidance for those planning and delivering platform trials for pediatric oncology.
The toolkit release marks the culmination of a two-year multi-stakeholder effort. In October 2024, the MRCT Center convened a group of experts for a two-day workshop, “Advancing Pediatric Platform Trials: Streamlining Development, Maximizing Impact,” that examined platform trials across pediatric oncology, major depressive disorder, and multidrug-resistant tuberculosis. A July 2025 follow-on workshop focused specifically on pediatric oncology, developing an implementation framework for academic and industry platform studies.
The C3PT resource includes a range of tools that support the user in putting that framework into practice. The toolkit offerings guide the user in determining whether a platform trial is the right trial design, what the optimal timing is for sponsor and regulatory interactions, guidance on templated sections for PIPs and iPSPs, considerations related to intellectual property and contracting, operational planning, and funding models.
The webinar will include opening remarks, a moderated multi-stakeholder discussion, and audience Q&A.
Investigator Oversight in Decentralized Trials: New Resources and Practical Tools
Thursday, September 24, 12:00 – 1:00 PM ET
The Investigator Oversight in Decentralized Trials project builds on the MRCT Center and Medable’s prior IRB/EC Considerations for DCT Review. As data capture and trial activities increasingly occur outside traditional trial sites, the characteristics of decentralized trial conduct have created uncertainty about Investigator oversight and how it should be structured when the PI has no supervisory or contractual role with others collecting data and conducting trial activities.
To help close that gap, the MRCT Center and Medable developed four new resources for investigator oversight in clinical trials with decentralized elements (DCTs), with input from the Investigator Oversight in DCT task force. These resources include a proportional oversight framework, an approach to optimize DCT elements, a model instruction sheet for local healthcare providers, and a set of illustrative scenarios covering roles and responsibilities in common clinical situations from withdrawal requests to serious adverse events.
On Thursday, September 24, 2026, from 12:00 PM – 1:00 PM ET, the MRCT Center and Medable will host a webinar to release the resources and walk through their intended use and how they fit together.
Public Review of the Clinical Research Glossary is now open
Public Review is a critical part of the Clinical Research Glossary process. As part of the CDISC global plain-language standard, every new term and definition, along with change requests received throughout the year, goes through Public Review before becoming part of the standard, to ensure the language is clear and easy to understand.
Public Review is open now through July 13, 2026, with 27 new and revised terms available for comment. The Clinical Research Glossary, a CDISC global standard since 2023, currently offers 216 plain-language definitions for terms used across the clinical research enterprise.
Your feedback maintains the glossary as a living, consensus-driven standard. Review the terms and submit your comments here. To help spread the word, share the media kit.
Related: Our June 16 webinar, The Clinical Research Glossary: Adoption, Implementation, and Impact, is now available on demand. Sylvia Baedorf Kassis, Program Director for the MRCT Center’s Health Literacy portfolio, hosted a conversation with Anna Subrizi (Bristol Myers Squibb), Sudipta Chakraborty (Biogen), and patient partner Bernard Coley on how sponsors integrate the glossary across research, commercial, and patient-facing work, and on the business case for plain language. The session also previewed the new terms now open for public review and demonstrated how to submit feedback.
JTF Global Biannual Meeting Advances the Competency Framework Toward Version 4.0
On Monday, June 22, the Joint Task Force for Clinical Trial Competency (JTF) held its latest Global Biannual Meeting, one of two gatherings the JTF community convenes each year to support the practical implementation of the JTF Core Competency Framework. The framework defines the knowledge, skills, and attitudes the clinical research workforce needs to conduct safe, ethical, and high-quality trials, organized into eight competency domains and 47 leveled competency statements written at fundamental, skilled, and advanced levels.
This meeting highlighted the work of two JTF workgroups. The first, the JTF-Patient Partner Project (P3), focuses on integrating patients as partners into the leadership of clinical research. The second is a proposed update to Domain 6, Data Management and Informatics. Presenters walked through each change and gathered stakeholder input that will help shape Version 4.0 of the framework. A small task force to revise the JTF will commence in October 2026.
The JTF is anchored at the MRCT Center, which stewards the framework and its ongoing evolution. A recording of the meeting is now available on demand for those who could not join live.
The next JTF Global Biannual Meeting takes place on December 1, from 1:00 – 3:00 PM ET. The meeting is free and open to all. Click here to register.
Public Comment
June 24: The MRCT Center submitted a public comment in response to the NIH National Library of Medicine’s request for information, “Future Directions for the NLM Information Resource Grants (G08) Program.” The comment affirms strong support for NLM’s mission and the trustworthy resources it offers through PubMed, ClinicalTrials.gov, GenBank, and MedlinePlus, and proposes several ways to expand the G08 program with a focus on clinical trials and research. READ MORE
June 25: The MRCT Center submitted a public comment in support of the European Data Protection Board’s Guidelines 1/2026 on the processing of personal data for scientific research purposes. The comment welcomes the Guidelines as a meaningful step toward clearer interpretation of the GDPR’s research provisions, endorsing the presumption of compatibility for secondary research, broad consent, and a research-specific approach to controller and processor roles. It also asks the EDPB to clarify how the Guidelines interact with the European Health Data Space, to allow GDPR data-processing consent to be included in the clinical trial consent form, to provide clearer examples of when erasure may compromise a trial, and to provide a workable pathway for sharing pseudonymized data.
June 28: The MRCT Center submitted responses to several TEHDAS2 draft guidelines to Health Data Access Bodies offered for public consultation, including one on international and third-country access and transfer of electronic health data; on linkage of health data sets; on informing citizens about the use of health data; and on handling research outcomes. We continue our efforts to engage stakeholders and guide policy development towards a harmonized data-sharing system for secondary use purposes related to the European Health Data Space (EHDS).
Publications
June 22: “Language as an Eligibility Criterion in Pediatric Study Protocols Conducted in Europe (2007–2024) Reported in the ClinicalTrials.gov Database,” published in Pharmaceutical Medicine and led by Begonya Nafria with co-author Barbara Bierer, examined pediatric clinical trial protocols conducted in the EU and found that language-based eligibility requirements, only a minority of which offered any scientific justification, limited cross-border access to trials for pediatric patients.
Events & Presentations
June 1-2: Barbara Bierer participated virtually in the third Open Expert Meeting on the Revision of the WMA Declaration of Taipei (DoT) on Ethical Considerations regarding Health Databases and Biobanks, focused on Equity, Global Challenges, and Ethical Considerations, held in Vatican City.
June 4-5: Sylvia Baedorf Kassis gave a plenary lecture and participated in panel discussions at the FACILITATE final meeting in Modena, Italy.
June 8: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topics: Use of AI in Clinical Trials – Exploration of Key Legal and Regulatory Issues – Part 2. This meeting is open to sponsors of the Research, Development, and Regulatory Roundtable (R3). For more information about this ongoing forum and how to join, click here.
June 11: Sarah White joined MRCT Center Executive or Steering Committee representatives Benjamin Rotz (Eli Lilly), Crispin Woolston (Sanofi), and Karla Childers (Johnson & Johnson) on a panel focused on post-trial continued access at the 2026 World Orphan Drug Congress in Boston.
June 15: Sarah White presented at the DIA Global Annual Meeting in Philadelphia: “Enabling Faster Multi-Regional Study Start-Up Through Regulatory Reliance and Harmonization,” examining how regulatory reliance and harmonization, guided by ICH E17 and E5, can streamline global development.
June 16: Webinar:The Clinical Research Glossary Biannual Meeting: Adoption, Implementation, and Impact. Now available on demand here.
June 22: Joint Task Force for Clinical Trial Competency (JTF) Biannual Global Meeting. Now available on demand here.
September 1 – Postponement: The MRCT Center and Vivli are postponing the European Health Data Space (EHDS) forum previously scheduled on September 1. Immediately following the October 21 MRCT Center Annual Symposium, we will host an in-person (and virtual) meeting on October 22 with a half-day session focused on data sharing broadly, including a panel on the European Health Data Space (EHDS). We invite you to join us for this discussion.
September 3: Meeting of the Research, Development, and Regulatory Roundtable (R3). This meeting is open to sponsors of the Research, Development, and Regulatory Roundtable (R3). For more information about this ongoing forum and how to join, click here.
September 8: Meeting of the Bioethics Collaborative. Topic: What’s Mine is Mine and What’s Yours is Yours: Data Ownership and Sovereignty. For more information about the Bioethics Collaborative and how to join this ongoing forum, click here.
September 15: TRACE Bioethics Forum, hosted by Kenya. Topic: Review and oversight of Controlled Human Infection Model (CHIM) studies.
September 22, 10 – 11 AM ET: Advancing Childhood Cancer Platform Trials: C3PT Toolkit Launch (Please see Spotlight above)
September 24, 12:00 – 1:00 PM ET: Investigator Oversight in Decentralized Trials: New Resources and Practical Tools (See Spotlight above)
October 21 – 22: MRCT Center 2026 Annual Symposium. Join us for discussions and presentations on ethical, actionable, and practical solutions to today’s global clinical research challenges. (Please see spotlight above)
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.
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