Please join us on Monday, May 18, from 12:00 – 1:00 pm ET for the fourth webinar in the MRCT Center’s AI Digital Twins and Synthetic Data series. This webinar will focus on data provenance and quality, model validation, and the emerging infrastructure needed to support the clinical and regulatory adoption of these technologies. It will explore how to evaluate whether the models used are credible, whether the data underlying them are reliable and traceable, and whether the outputs can be verified and validated for use in regulatory and clinical decision-making. Panelists will discuss what it means for a model to be “fit for purpose,” how definitional differences among these technologies shape regulatory review, and how clinicians, sponsors, reviewers, and regulators may use, interpret, and deploy these tools. The session will include a moderated discussion and time for audience Q&A.
Join us on Wednesday, May 20, from 12:00 PM to 1:00 PM ET for a webinar introducing new tools to support investigator oversight in trials with decentralized elements. Developed by the MRCT Center and Medable, in collaboration with the PI-Oversight in DCT task force, these resources reflect cross-sector input and address the evolving responsibilities of investigators in DCT settings. This work builds on the MRCT Center’s prior guidance for IRB/EC review of decentralized trialsand continues to expand the DCT project portfolio with practical, ethics-grounded tools.
Moderator: Barbara Bierer, Faculty Director, MRCT Center
ICH E6(R3) represents a major modernization of Good Clinical Practice since the original 1996 guideline, building on the risk-based and quality-focused principles introduced in E6(R2). It further emphasizes a proportionate, risk-based approach to trial design and conduct, incorporating Quality by Design and risk proportionality as foundational principles. The guideline expands expectations for data governance and clarifies sponsor and investigator responsibilities. However, guidelines alone do not drive change in practice; effective implementation depends on training and education.
As the ICH training partner selected to develop the ICH E6(R3) training curriculum, the MRCT Center, in collaboration with the ICH E6(R3) Expert Working Group, is producing a five-module course to translate the ICH document into actionable guidance for the people who run trials.
Clinical Trials Week honors trial participants and the workforce whose training and preparation shape their care. In that spirit, join Sarah White and a panel of experts representing the US FDA and industry sponsors, who are also members of the ICH E6(R3) Expert Working Group, to highlight the importance of implementing the ICH E6(R3) guideline correctly and discuss key areas of the ICH E6(R3) guideline that may be challenging to implement.
The session will walk through a practical case example applying Quality by Design principles, including the identification of Critical to Quality factors, and will explore implementation of ICH E6(R3) across key areas, such as data governance, sponsor and investigator responsibilities, and the incorporation of diverse perspectives in trial design and planning. The session will underscore the importance of all individuals performing clinical trial activities in understanding these critical study attributes and how their role contributes to safeguarding them and ensuring they are consistently protected through their day-to-day decisions and actions. It will also spotlight the available ICH E6(R3) training modules. Attendees will leave with an understanding of the foundational concepts in ICH E6(R3), how Quality by Design can be applied to clinical trial design and conduct, and how to introduce and disseminate the training to their teams.
Topic: Digital Doppelgängers: Ethics of Digital Twins and Synthetic Data
Abstract: Clinical trial design, conduct, and analysis are benefiting from the increased use of AI, rendering it essential to address the ethical considerations that arise when new (or newer) modalities are introduced. In the last few years, AI-enabled synthetic data, retaining the characteristics of original individual-level datasets but containing no actual personal health information, has been used to conduct preliminary hypothesis generation and testing, to model eligibility criteria, and to overcome privacy concerns, particularly in rare disease research. Digital twins are AI-generated models of individual patients that simulate disease progression and treatment response, updated dynamically with real or inferred data from the physical (actual) twin. They have been used for predictive modeling and to modify trial design, the number of enrollees, and/or power calculations, increasing efficiency. They can be used prospectively (e.g., augmenting control arms) or for decision support. In both synthetic data and digital twin settings, key ethical questions arise, but each operates at a different level of abstraction.
Synthetic data are artificially generated datasets created to mimic the characteristics and distributions of patient populations statistically, but they do not correspond to identifiable individuals. Synthetic data can be used, for example, to train generative AI, minimizing privacy concerns early in AI development, and/or for trial simulation. Synthetic data, however, do not support inference at the individual level. The utility of synthetic data depends on the dataset from which it was generated; assessing bias in the source dataset is important but challenging in practice. In ultrarare diseases, for example, sufficient and representative data may not even be available. As a dataset becomes more limited and fails to capture the diversity of the patient population (as in rare and ultrarare diseases), the less generalizable its derivatives and outputs. Does the use of synthetic data reproduce and embed bias and perpetuate health inequalities? How certain are we that synthetic data are – and remain – anonymous?
In contrast, digital twins are constructed from individual participant data, are “personalized,” and acquire, ingest, and use real-time data to refine and update their attributes over time. Do participants have an implicit right to or expectation of consent to the use of their data for the construction of “their” digital twin? Does the creation of a digital twin increase the risk of reidentification and downstream privacy harms? What are the responsibilities for protecting the digital twin data, and the range of permissible future uses of digital twin data? For example, developing a digital twin may yield diagnostic, therapeutic, or other useful information about a person’s future health. Should that be disclosed or communicated? What degree of certainty is necessary for that disclosure to be warranted or permissible? Do the considerations or processes of ethics review bodies need to evolve for the review of protocols involving digital twins or synthetic data, or should additional protections be considered, as a condition of approval?
In clinical research, there is an expectation that the data that inform a trial’s results will be available for independent reanalysis and validation of the results, and to facilitate discovery. The future use of synthetic data and digital twin data, however, is complicated. At a minimum, the synthetic data represents a stable dataset that can benefit from a persistent data object identifier. But does the metadata always reflect that the dataset is derived, and should the original training dataset be available for query, reintroducing privacy risks? Digital twin data, however, is consistently updated based on the acquisition of dynamic, real-world data. How will that be reflected in the trial data? Should the original informed consent include permission for its potential secondary use, particularly as more mature digital twin data becomes increasingly identifiable?
This meeting is open to sponsors of the MRCT Center Bioethics Collaborative and select invited guests. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
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: Use of AI in Clinical Trials – Exploration of Key Legal and Regulatory Issues (continued). This is the continuation of a discussion first introduced at the April 9, 2026 R3 meeting.
The MRCT Center Clinical Research Glossary, a CDISC global standard since 2023, offers 216 plain-language definitions for clinical research terms used across the research enterprise.
Sylvia Baedorf Kassis, Program Director for the MRCT Center’s Health Literacy portfolio, will host a conversation with panelists from two sponsor organizations and a patient partner on how the glossary is being adopted, implemented, and used in practice.
Panelists include Anna Subrizi, Patient Empowerment Team Lead at Bristol Myers Squibb; Sudipta Chakraborty, who leads the Health Literacy Center of Excellence at Biogen; and Bernard Coley, a patient partner who applies the glossary in his Parkinson’s disease advocacy and education work.
The panel will cover how sponsors integrate the glossary across research and development, commercial, and patient-facing functions, as well as the business case for plain language and its impact within organizations and clinical research studies.
The MRCT Center will also share a preview of the new terms heading into a 30-day public review this June. Public review ensures that the glossary is a living, consensus-driven CDISC global standard. Each new definition is reviewed by researchers, sponsors, patients, and advocates before adoption, so the professionals who design trials have a trusted resource to communicate with participants and help enable informed decision-making. Attendees will learn what public review entails and how to submit feedback through the MRCT Center survey or the CDISC Wiki JIRA process.
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.
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: What’s Mine Is Mine and What’s Yours Is Mine: Data Ownership and Sovereignty
This meeting is open to sponsors of the MRCT Center Bioethics Collaborative and select invited guests. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
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.
This meeting is open to sponsors of the MRCT Center Bioethics Collaborative and select invited guests. For more information about the Bioethics Collaborative and how to become a sponsor, click here.
