Tag: 2025

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

AI Digital Twins and Synthetic Data: Application to Clinical Trials

Webinar

September 30, 2025 @ 11:00 am – 12:30 pm

Please join us on Tuesday, September 30, 2025, from 11:00 am–12:30 pm ET for a webinar on the applications of AI digital twins and synthetic data to clinical trials. Digital twins refer to simulated models of individual patients designed to predict disease trajectories and/or treatment responses, offering the potential to enhance statistical power, optimize trial design, and limit the number of participants assigned to a control arm. Synthetic data are artificially generated datasets that mirror the statistical properties of verified clinical data. Both technologies are or are being developed for use in the design, conduct, and analysis of clinical trials, and with the intention of use for regulatory submissions. This webinar will serve as an introduction to these emerging technologies and a starting point for examining their implications, opportunities, and challenges in clinical research.

Key Topics:

  • Introduction to digital twins and synthetic data, including their core functions and how they differ from traditional statistical modeling approaches.
  • Exploration of ethical, statistical, and regulatory considerations for adopting digital twins and synthetic data in the design and conduct of clinical trials.
  • A panel discussion featuring expert perspectives on the evolving role of AI digital twins and synthetic data in clinical research. 
A Framework for AI Adoption and Oversight in Clinical Research
Framework for Review of Clinical Research Involving AI

Continued Access to Investigational Products: Guiding Equitable and Fair Decisions

Webinar

September 12, 2025 @ 11:00 am – 12:00 pm

Please join us on Friday, September 12 from 11 AM – 12 PM ET for a webinar to discuss the MRCT Center’s ongoing work related to the challenges of post-trial continued access to investigational products. Post-trial continued access is a shared responsibility and should be determined before the trial begins. Even with the best planning, complex situations can arise that require research sponsors to balance various tradeoffs and impacts on stakeholders. The MRCT Center’s Post-Trial Continued Access Task Force has developed resources to guide equitable and fair decision-making related to the continued provision of the investigational medicine, or continued maintenance of the investigational significant risk device after the trial.

This webinar will introduce a series of resources, including principles, frameworks, and recommendations. Case studies will also be presented to illustrate unique complexities that sponsors and investigators must consider.

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.

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.