CLINICAL TRIALS & RESEARCH
Your Voice, Global Impact: Join the Clinical Research Glossary’s Annual Public Review Process

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June 24, 2025

12:00 pm ET - 1:00 pm ET

Location:

virtual

Your Voice, Global Impact: Join the Clinical Research Glossary’s Annual Public Review Process

June 24, 2025 @ 12:00 pm 1:00 pm

virtual

Presented on: June 24, 2025

Join us on June 24 from 12 – 1 PM ET to learn about the MRCT Center’s Clinical Research Glossary, a collaboratively developed plain language resource designed to enhance understanding of clinical research terminology. Discover how you can participate in the annual Public Review—an essential step toward making these terms a CDISC global standard. Your involvement ensures the glossary remains accurate, inclusive, and effective for informed decision-making in clinical research. 

Key Topics: 

  • Why your voice matters in Public Review 
  • How to easily participate and submit feedback 
  • The role of Public Review in shaping global clinical research standards 
  • The terms and definitions going through Public Review 

Related Resources

The Clinical Research Glossary: Learn More
The Clinical Research Glossary: Working Group
Implementing the Clinical Research Glossary: How to Attribute the MRCT Center
On-Demand Webinar: The Clinical Research Glossary: New Words, New Opportunities
On-Demand Webinar: A Global Standard for Plain Language in Clinical Research: an MRCT Center and CDISC Collaboration

June 24, 2025

3:00 pm ET - 4:00 pm ET

Location:

A Framework for AI Adoption and Oversight in Clinical Research

Webinar

June 24, 2025 @ 3:00 pm 4:00 pm

Please join us on Tuesday, June 24, from 3:00-4:00 pm ET for a webinar to launch the MRCT Center and WCG’s Review Framework for Protocols Involving Artificial Intelligence (AI). This framework supports Institutional Review Boards (IRBs) in reviewing research where AI is part of the intervention. The framework was developed through a multi-disciplinary task force, and these actionable tools offer both (1) structured guidance grounded in U.S. regulations and (2) ethical considerations to assist IRBs in evaluating benefits and risks while ensuring oversight and transparency across the AI development lifecycle. This session introduces a practical decision-making resource intended to help IRBs determine when and how to apply appropriate and proportionate oversight to protocols involving AI.

Key Topics:

  • Introduction to the IRB review framework focusing on aligning review practices with existing regulations and ethical standards.
  • Structured questions IRBs can use to assess risk, benefits, and ethical considerations when AI is used as a research intervention.
  • An expert panel discussion on navigating ethical considerations and the question of “AI Exceptionalism” during IRB review.



June 26, 2025

1:00 pm ET - 2:00 pm ET

Location:

Patient-Centered Long-Term Follow-Up for Gene Therapies

Webinar

June 26, 2025 @ 1:00 pm 2:00 pm

Please join us on Thursday, June 26, from 1:00-2:00 pm ET, for a webinar in which we will discuss patient-centered approaches in the specific context of Gene Therapy (GT) Long-Term Follow-Up (LTFU) studies.

GTs have the potential for long-lasting and transformative health benefits, but there are also possible long-term health risks. Therefore, the FDA recommends long-term safety monitoring of recipients of certain types of GTs to minimize and better understand any health risks. Although important, these LTFU studies can last years and may pose significant burdens on patients, so it is critical to consider patient needs and preferences in the design and conduct of LTFU for GTs.

Three panelists will offer different perspectives on how we can put patients at the center of LTFU for GTs:

George Eastwood serves as Executive Director for the Emily Whitehead Foundation (EWF). The EWF funds groundbreaking research for pediatric cancer patients while simultaneously advocating for increased access to innovative therapies and supporting patients on their treatment journey. Mr. Eastwood will provide an overview of the Foundation’s work on addressing concerns about patient loss to follow-up in GT LTFU studies.  

Dr. Jessica Scott is CEO of Legacy Health Strategies. As a patient engagement leader, she works to drive the culture change of increasing patient perspectives in the health care industry, which in turn will propel mutually beneficial outcomes for organizations and the patients they serve.  She will share perspectives on how patient-centric approaches can be applied to GT LTFU. 

Tesha Samuels has journeyed from a Sickle Cell patient to a beacon of hope, advocacy, and activism. Her story is a testament to the power of patient voices in shaping better, more compassionate healthcare systems. Her nonprofit, Journey to ExSCellence, is dedicated to empowering individuals affected by Sickle Cell Disease. Ms. Samuels will share perspectives on GT LTFU as both a patient herself and an advocate for others.