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October 22, 2025

8:00 am ET - 6:00 pm ET

Location:

MRCT Center 2025 Annual Symposium

Meeting

October 22, 2025 @ 8:00 am – 6:00 pm

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.

2025-10-03 Annual Symposium Draft Agenda for websiteDownload

Bioethics Collaborative

October 30, 2025

12:00 pm ET - 1:00 pm ET

Location:

Applied Health Literacy: Using Teach-Back in Conversations about Clinical Research

October 30, 2025 @ 12:00 pm – 1:00 pm

October is Health Literacy Month! Please join us on Thursday, October 30, from 12 – 1 PM ET for a webinar to explore teach-back (TB) within the clinical research context. 

We begin with teach-back—its essential elements, how to use it, and why it is important to safe, high-quality, equitable health care and research. We then explore approaches for incorporating teach-back into different types of clinical research conversations.

The session will center on the importance of strong verbal communication skills and the ways teach-back can be used by study teams to foster clear, impactful, and empowering dialogue with patients, participants, and caregivers.  

We will explore how study teams can simplify complex verbal information through plain language, assess and confirm understanding via teach-back throughout the recruiting and informed consent process, and support participant understanding throughout their clinical research experience.  Registrants will receive tips and resources to support incorporating this best practice into their everyday clinical research processes.   

Objectives:

  • Explain what teach-back is, its importance, and why to use it;  
  • Describe approaches that support incorporating teach-back into clinical research conversations across the clinical trial life cycle;
  • Identify and access resources that explain how to use teach-back.
Clinical Research Glossary

Bioethics Collaborative

November 4, 2025

11:00 am ET - 12:00 pm ET

Location:

Long-Term Follow-Up for Gene Therapies: Toolkit Release

Webinar

November 4, 2025 @ 11:00 am – 12:00 pm

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.

Key Topics:

  • An overview of the draft Toolkit for Long-Term Follow-Up Studies in Gene Therapies
  • Perspectives from working group members
  • Q&A and discussion

February 9, 2024

Cell and Gene Therapies ›

Bioethics Collaborative

November 13, 2025

1:00 pm ET - 3:30 pm ET

Location:

hybrid

Meeting of The Research, Development, and Regulatory Roundtable (R3)

November 13, 2025 @ 1:00 pm – 3:30 pm EST

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

Research, Development, and Regulatory Roundtable (R3)

November 18, 2025

12:00 pm ET - 1:00 pm ET

Location:

AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research

Webinar

November 18, 2025 @ 12:00 pm – 1:00 pm

Please join us on Tuesday, November 18, 2025, from 12:00 pm – 1:00 pm ET for the second webinar in our Digital Twins and Synthetic Data series, focusing on practical use cases in clinical research. This session will explore how digital twins and synthetic data are being used to enhance the efficiency of clinical trials, including reducing the size of control arms, enhancing Bayesian statistical analysis, supporting single-arm trials, and optimizing the design of future trials. Dr. Daniele Bertolini of Unlearn.ai will share examples and reflect on lessons learned from deploying these tools across various therapeutic areas. The session will include a moderated discussion and audience Q&A.

AI Digital Twins and Synthetic Data: Application to Clinical Trials
A Framework for AI Adoption and Oversight in Clinical Research
Framework for Review of Clinical Research Involving AI

Bioethics Collaborative

December 8, 2025

9:30 am ET - 1:00 pm ET

Location:

Hybrid: In-person (Boston) and Virtual (Zoom) 800 Boylston St., Boston, MA

Meeting of the Bioethics Collaborative 

December 8, 2025 @ 9:30 am – 1:00 pm

Hybrid: In-person (Boston) and Virtual (Zoom)

800 Boylston St.
Boston, MA 02199

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.

December 10, 2025

1:00 pm ET - 3:00 pm ET

Location:

Joint Task Force for Clinical Trial Competency (JTF) Global Biannual Meeting

Meeting

December 10, 2025 @ 1:00 pm – 3:00 pm

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 the JTF Biannual Global Meeting on December 10, from 1:00 – 3:00 PM ET, to hear about global perspectives on implementing the JTF Framework, which may include updates from the United Arab Emirates, New Zealand, and the United States, including utilizing the JTF Framework for experiential learning, and training and assessment of clinical research professionals and clinical data scientists. This meeting is free and open to all registrants.

All registrants will receive slides and a meeting summary after the meeting.

Bioethics Collaborative

March 10, 2026

9:30 am ET - 12:30 pm ET

Location:

Hybrid: In-person (Boston) and Virtual (Zoom) 800 Boylston St., Boston, MA

Meeting of the Bioethics Collaborative 

March 10, 2026 @ 9:30 am – 12:30 pm

Hybrid: In-person (Boston) and Virtual (Zoom)

800 Boylston St.
Boston, MA 02199

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.

September 8, 2026

10:00 am ET - 12:30 pm ET

Location:

Hybrid: In-person (Boston) and Virtual (Zoom) 800 Boylston St., Boston, MA

Meeting of the Bioethics Collaborative 

September 8, 2026 @ 10:00 am – 12:30 pm

Hybrid: In-person (Boston) and Virtual (Zoom)

800 Boylston St.
Boston, MA 02199

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.