Tag: 2025

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

Clinical Research Glossary

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

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.  

February 9, 2024

Cell and Gene Therapies ›

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.

A Shared Language for Clinical Research: How Technical Organizations are Embracing Plain Language and Implementing the MRCT Center Clinical Research Glossary 

Webinar

May 8, 2025 @ 10:00 am – 11:00 am

A common misconception is that easy-to-understand, plain language information is only necessary in limited situations. However, adopting health literacy best practices benefits everyone who encounters simplified, thoughtfully designed scientific information even in highly technical areas like the data sciences.

In this webinar on Thursday, May 8, from 10 – 11 AM ET, leaders from the Society for Clinical Data Management (SCDM) and the Clinical Data Interchange Standards Consortium (CDISC) will join the MRCT Center to explain why plain language information is essential in the data sciences and how the organizations have embraced a culture of health literacy. This approach benefits both industry members, as well as patients, participants, and their caregivers.

Join us to learn how integrating health literacy and plain language resources improve communication and understanding in clinical research.

Key Topics/Objectives:

By the end of the webinar, attendees should be able to:

  • Understand the connection between health literacy and data sciences, and why this is a priority for many organizations.
  • Explain how health literacy and plain language resources have been integrated into organizational initiatives.
  • Identify opportunities to implement health literacy best practices within their own organizations.

We appreciate your interest and look forward to an engaging discussion.

Innovative Approaches for Gene Therapy Long-Term Follow-Up: Leveraging Registries and Platform Trials

Webinar

May 6, 2025 @ 1:00 pm – 2:00 pm

Please join us on Tuesday, May 6, from 1-2 pm ET for a webinar that will explore different approaches for realizing Gene Therapy (GT) Long-Term Follow-Up (LTFU). GTs have the potential for long-lasting and transformative health benefits, but there are also long-term health risks. Therefore, the FDA recommends long-term safety monitoring of recipients of certain types of GTs. As these LTFU studies can last years (even up to a lifetime), they pose significant scientific and logistical challenges. We are grateful for our three distinguished panelists, who will discuss innovative approaches for GT LTFU. 

Dr. Barbara Konkle, a hematologist at the Washington Center for Bleeding Disorders, Professor of Medicine Emeritus in Hematology-Oncology at the University of Washington, and the Medical Director of the Bleeding Disorders Laboratory at Bloodworks NW, will share information about the goals and development of the World Federation of Hemophilia’s Gene Therapy Registry (GTR). The GTR is a prospective, observational, and longitudinal registry designed to collect long-term data on people with hemophilia who receive GT. 

Dr. Amy Moskop is an Assistant Professor in the Department of Pediatrics and the Division of Hematology/Oncology/BMT at the Medical College of Wisconsin and the Scientific Director of the Gene Therapy Program at the Center for International Blood and Marrow Transplant Research (CIBMTR). Dr. Moskop will provide an overview of the CIBMTR registry and its intersection with GT LTFU. 

Dr. Avery McIntosh, Director, Biostatistics, Internal Medicine and Infectious Disease at Pfizer, will share practical considerations for GT LTFU safety studies and provide an overview of the potential benefits of platform and master protocol approaches. Dr. McIntosh has co-authored a paper on this topic, published in 2024 (doi:10.1002/cpt.3087). He has co-edited a book, Development of Gene Therapies: Strategic, Scientific, Regulatory, and Access Considerations, also published last year.

Dr. Carolyn Riley Chapman, who leads the Cell and Gene Therapies project at the MRCT Center, will moderate.

February 9, 2024

Cell and Gene Therapies ›

Data Literacy: Enhancing Trust and Transparency

Webinar

April 3, 2025 @ 10:00 am – 11:00 am

A key aspect of health literacy—especially in clinical research—is understanding what data is collected, how it is protected, and how it is used during and after a study. Truly informed consent requires transparency about data practices so that participants can make educated decisions.

The MRCT Center and PHUSE are collaborating to develop a suite of resources, including videos and infographics, to enhance data literacy in the clinical research context. Join us for this webinar as we discuss the importance of data literacy, explore practical applications for research teams, and unveil new materials designed to support participants and the broader research community.

Key Topics:

  1. Advancing Data Literacy as a Component of Health Literacy
    • Explore how understanding research data supports informed decision-making and aligns with broader health literacy efforts.
  2. Applying Plain Language and Visual Tools to Data Communication
    • Learn how the MRCT Center and PHUSE have used plain language and infographics to make clinical research data more accessible.
  3. Empowering Participants with Transparent and Actionable Information
    • Identify ways to integrate data literacy resources into your clinical research processes to support research trust and engagement.

Therapeutic Misconception Revisited 

June 4, 2025 @ 1:00 pm – 3:30 pm

Location: Hybrid

Topic: Therapeutic Misconception Revisited

Abstract: The lines between research and care continue to blur. Pragmatic research studies comparing accepted therapies are increasingly embedded seamlessly into clinical practice. More and more, participation in research deemed promising is offered to patients before standard therapies are exhausted, sometimes as a first-line option. While the concept of “therapeutic misconception”—in very broad strokes, the tendency for individuals to misapply attributes of clinical care to research—has been a mainstay of research ethics for over 40 years, these developments provide an occasion, and perhaps even an urgent need, to revisit it and related topics. How exactly should we understand the therapeutic misconception and what it involves, particularly in cases where the line between research and care really is vague and hard to determine? Even more basically, how should we understand the relationship between research and care in the first place? Are concerns over therapeutic misconception still important, or do they perhaps reflect naïve understandings of research and care and the relation between them–particularly in cases where current options are limited? 

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.

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

Meeting

June 2, 2025 @ 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.

Join the JTF Biannual Global Meeting on June 2, from 9:00 – 11:00 AM ET, to explore the latest advancements in clinical research workforce development and competency-based training. This session will feature global perspectives on implementing the JTF Framework, including:

  • Results from a Delphi study on data management competencies
  • Expanding the Core Competency Framework to include patient, participant, and public engagement and partnership: Updates from the Patient Participant Project workgroup
  • How Arizona State University’s Clinical Research Management program integrates the JTF Framework into both its curriculum and accreditation approach
  • Comprehensive leveling of the Clinical Research Professional Career Ladder at Johns Hopkins University

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

Global Development of a Clinical Research Workforce: Tools and Resources

Webinar

April 3, 2025 @ 9:00 am – 10:00 am

Join us on April 3 from 9 – 10 am ET for a webinar dedicated to Global Workforce Development: Tools and Resources, featuring a keynote by Lembit Rago, Secretary-General of the Council for International Organizations of Medical Sciences (CIOMS). Dr. Rago will share insights on CIOMS initiatives to define and synthesize professional competencies essential for clinical research and the need for cooperative agreements to harmonize workforce development efforts.

The session will also highlight the Joint Task Force for Clinical Trial Competency (JTF) Framework as a foundational tool for training and professional development, addressing the challenges and opportunities of recruiting and retaining a diverse and capable workforce.

Sally Armstrong, CEO of PRAXIS Australia, will share how PRAXIS Australia has used the JTF Framework in their educational offerings, including courses, workshops, and immersive onsite training programs.

Susan Landis, Executive Director of the Association of Clinical Research Professionals (ACRP), will discuss ACRP’s  “Partners Advancing the Clinical Research Workforce,” an initiative aimed at building a diverse and qualified clinical research workforce through training programs, educational resources, and collaborations with industry leaders, based on the JTF Framework, to address the needs of the clinical research field by providing pathways for new entrants and career advancement for existing professionals.

This webinar will provide actionable and practical strategies to support global clinical trial professionals.

Key topics:

  • Utilizing the JTF Framework to define and develop competencies in clinical research
  • Developing the education and training paradigm for the clinical research workforce
  • Recruiting and retaining a diverse and representative clinical research workforce