This webinar will explore key challenges, opportunities, and best practices for successful partnerships between academia and the pharmaceutical industry to design and deliver platform trials for children and adolescents with cancer.
The MRCT Center is co-presenting a PRIM&R webinar on putting ICH E6(R3) into practice, and CIP credits are available. E6(R3) was adopted in January 2025 (Principles and Annex 1) and June 2026 (Annex 2). Quality by design, fit-for-purpose, risk proportionality, and essentiality of a record are now everyday vocabulary. What does that mean for IRBs, Investigators, and research teams? How do IRBs approach protocol review with a risk-proportionate lens? How do Investigators exercise appropriate oversight of research and determine which essential records should be maintained on file? David Nickerson, Head of Clinical Quality Management at EMD Serono and PhRMA Topic Lead for ICH E6(R3); Rebecca Stanbrook, Consultant at RESaltas GmbH, EFPIA Topic Lead for ICH E6(R3); and Benjamin C. Silverman, MD, Senior IRB Chair in Human Research Affairs at Mass General Brigham, will lead the panel, moderated by Sarah White, MRCT Center Executive Director.
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.
Topic: What’s Mine Is Mine and What’s Yours Is Mine: Data Ownership and Sovereignty
Abstract: As big data and AI become more widespread, concerns about data privacy and security have intensified, with many countries restricting access to their citizens’ data (and, in some settings, to data stored in those countries, regardless of citizenship). International ethical guidelines, such as the Declaration of Taipei, state that individuals are entitled to control the use of their personal data. But most people fail to appreciate how much of their data is already publicly available, how much of their data they can no longer control, and how extensive their digital footprint is. When they do learn, individuals feel excluded from decisions about their information and express the desire to determine how their data is accessed and used. Are data ownership, consent, and permissions to control one’s existing data still realistic? Are there other ways to demonstrate respect when obtaining consent is not possible? Are there data governance models that can provide oversight for participant concerns or wishes? What actions, beyond consent, should be taken to respect or benefit the participants who contributed their data?
This meeting is open to sponsors of the MRCT Center Bioethics Collaborative and select invited guests. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
The MRCT Center Annual Symposium returns to Boston for a full day of discussions on ethical, actionable, and practical solutions to today’s global clinical research challenges. Free and open to all, in person or online.
Keynote: Karim Mikhail, Director, Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration
We are pleased to welcome Karim Mikhail as this year’s keynote speaker. Director Mikhail will give an update on Operation TrialBlazer, the HHS roadmap for maintaining U.S. leadership in early clinical research and development, and the initiatives planned under it. He brings more than two decades of leadership across industry and FDA.
Panel 1 | Response to Keynote: Ideation to Implementation and Scale
Leaders from industry and academic medicine respond to the keynote and discuss how Operation TrialBlazer’s planned initiatives can move from roadmap to practice.
Panelists: Ginny Beakes-Read, Johnson & Johnson; Karen Hartman, Mayo Clinic; Jennifer Sheller, Merck
Moderators: Barbara Bierer, MRCT Center; Mark Barnes, Ropes & Gray and MRCT Center
Panel 2 | Returning Summary Results to Participants: Lessons from the EU and UK Experience: Optimizing for US Application
NIH has released a draft policy on sharing summary-level study results with participants, with comments due October 26. Participant, researcher, and regulator voices from the EU and UK join NIH to discuss what they learned returning aggregate results, what they would do differently, and what they recommend for those just getting started.
Panelists: Adam Berger, U.S. National Institutes of Health; Johanna Blom, University of Modena, Italy; Clive Collett, Health Research Authority, UK; Veronica Popa, EURORDIS
Moderator: Sylvia Baedorf Kassis, MRCT Center
Panel 3 | Post-Trial Obligations: An Integrated Decision Model for Clinical Trial Placement
This panel explores the circumstances that challenge trial placement, when durable access is achievable in a host country or community, and when reciprocal benefits are acceptable if it is not. Panelists will also discuss the MRCT Center’s draft Integrated Decision Model for Clinical Trial Placement, developed by its Post-Trial Responsibilities Task Force to guide sponsors.
Panelists: Ginny Acha, Merck; Joseph Ali, Johns Hopkins University; Karla Childers, Johnson & Johnson
Moderator: Sarah White, MRCT Center
MRCT Center Updates
Select initiatives from across our portfolio:
AI and the Administration of Research
Childhood Cancer Academic–Industry Collaborative Platform Trials (C3PT)
Proportionate Oversight in Decentralized Clinical Trials
TRACE
Thursday, October 22 | Data Sharing
The second day focuses on data sharing and is co-organized with Vivli. Attend one day or both, in person or virtually. Please click here to view the draft agenda.
This webinar will focus on returning aggregate study results to participants as a patient-focused best practice that centers health literacy. After an introduction to the newly released NIH policy, contextualized within the global history of returning results, the panel will feature academic researchers discussing the essential elements of sharing their findings with participants, including why and how they do it, and what they have learned along the way. Attendees will come away with lessons they can incorporate as they consider their own return of results processes.
The Research, Development, and Regulatory Roundtable (R3) is a forum to discuss pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. Meetings convene policymakers, legal counsel, academicians, industry representatives, and global regulators. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.
This hybrid meeting is open to sponsors of the Research, Development, and Regulatory Roundtable.
The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, develops and disseminates standards and practices for the global clinical research workforce. By fostering a cohesive and collaborative approach, the JTF ensures that professionals have the competencies to conduct clinical trials ethically and effectively.
Our international team of investigators, educators, and clinical research professionals has developed and/or utilizes a framework that defines the knowledge, skills, and attitudes necessary for conducting safe, ethical, and high-quality clinical research.
This meeting is open to sponsors of the MRCT Center Bioethics Collaborative and select invited guests. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
