June 4, 2026 @ 2:00 pm – 4:30 pm
Topic: TBD
This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
Meeting of the Bioethics Collaborative
Focus Area: Clinical Trials & Research
Mitigating Financial Toxicity for Participants in Clinical Trials: Best Practice Considerations & Recommendations for Sponsors
Webinar
Presented on: December 9, 2025
Hosted by the MRCT Center, in collaboration with Equitable Access to Clinical Trials (EACT), a project convened by LUNGevity Foundation.
Clinical trials are vital to advancing medical knowledge and care, yet participation can impose significant financial burdens on participants and their families—from travel and time away from work to uncovered medical and ancillary expenses.
This webinar examined the sources and impact of these costs and highlighted emerging strategies to reduce financial hardship for research volunteers. Presenters also introduced tools, checklists, and other resources developed through the EACT Project, a collaborative forum advancing financial neutrality in clinical research participation.
Panelists
- Dr. David Gerber, Co-Director, Simmons Comprehensive Cancer Center Office of Education and Training; Professor, University of Texas Southwestern Medical Center
- Wendy K.D. Selig, Founder and CEO, WSCollaborative
Moderator
Dr. Barbara Bierer, Faculty Director, MRCT Center
Related Resources
EACT Project Resources
Joint Task Force for Clinical Trial Competency (JTF) Global Biannual Meeting
Meeting
June 15, 2026 @ 9:00 am – 11:00 am
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.
Join us on June 15, 2026, 9:00-11:00 AM ET for the Joint Task Force for Clinical Trial Competency (JTF) Biannual Global Meeting to hear about global perspectives on implementing the JTF Framework. Agenda specifics will be posted soon.
To learn more about the JTF Framework: https://mrctcenter.org/clinical-trial-competency/framework/overview/
All registrants will receive slides and a meeting summary after the meeting. This event is free.
Meeting of The Research, Development, and Regulatory Roundtable (R3)
November 5, 2026 @ 1:00 pm – 3:30 pm
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.
Topic: TBD
For more information, please email at MRCT@BWH.HARVARD.EDU
Deliverables
Projects
Meeting of The Research, Development, and Regulatory Roundtable (R3)
September 3, 2026 @ 1:00 pm – 3:30 pm
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.
Topic: TBD
For more information, please email at MRCT@BWH.HARVARD.EDU
Deliverables
Projects
Meeting of The Research, Development, and Regulatory Roundtable (R3)
June 10, 2026 @ 1:30 pm – 4:00 pm
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.
Topic: TBD
For more information, please email at MRCT@BWH.HARVARD.EDU
Deliverables
Projects
Meeting of The Research, Development, and Regulatory Roundtable (R3)
April 9, 2026 @ 1:00 pm – 3:30 pm
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.
Topic: TBD
For more information, please email at MRCT@BWH.HARVARD.EDU
Deliverables
Projects
Ethical, Legal, and Social Issues (ELSI) in Human Somatic Gene Therapy Clinical Research: A Scoping Review
Publication
Presented on: November 14, 2025
Published in: Human Gene Therapy
Carolyn Chapman, Mena Shaikh, Ava Glazier, Andrew Creamer, and Barbara Bierer published Ethical, Legal, and Social Issues (ELSI) in Human Somatic Gene Therapy Clinical Research: A Scoping Review in Human Gene Therapy. Dozens of gene therapies have been approved, and hundreds more are in development, prompting the need to better characterize the ethical, legal, and social implications (ELSI) of this emerging therapeutic class. The authors conducted a scoping review to map these issues across the literature, identifying themes related to risk–benefit assessment, engagement and communication, justice and access, ethical trial design, and the influence of financial and regulatory decision-making. The article also discusses potential approaches to address these ELSI as gene-therapy research expands.
Carolyn Riley Chapman, Mena Shaikh, Ava Glazier, Andrew Creamer, and Barbara E. Bierer Human Gene Therapy 202536:21-22, 1387-1404
Deploying Digital Twins and Synthetic Data in Evidence Generation
Webinar
January 15, 2026 @ 11:00 am – 12:00 pm
Please join us on Thursday, January 15, for the third webinar in the MRCT Center’s Digital Twins and Synthetic Data series. This session will examine the appropriate use of digital twins and synthetic data in evidence generation, including their potential role in regulatory submissions.
Panelists will discuss evidence quality, validation, and model transparency, and will reflect on the evolving regulatory landscape for these technologies in clinical research. The session will include a moderated discussion and time for audience Q&A.
Related On- Demand webinars
Related: AI Framework
AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research
Webinar
Presented on: November 18, 2025
This webinar focused on real-world examples and lessons learned from deploying synthetic data and digital twins across therapeutic areas.
Key Topics:
- Reducing the size of control arms
- Enhancing Bayesian statistical analysis
- Supporting single-arm trials
- Optimizing the design of future trials
Panelist: Daniele Bertolini, Machine Learning Scientist at Unlearn.ai.
Moderator: Barbara Bierer, Faculty Director at the MRCT Center