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.
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
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.
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.
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.
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 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
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.
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 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.
