On May 22, in recognition of Clinical Trials Week, MRCT Center Executive Director Sarah White convened the ICH E6(R3) Expert Working Group’s regulator and industry topic leads, Cheryl Grandinetti, U.S. FDA; David Nickerson, EMD Serono and PhRMA ; and Rebecca Stanbrook, RESaltas GmbH and EFPIA , for “Good Clinical Practice in Practice: Implementing ICH E6(R3).” The panel walked through the guideline’s foundational concepts (Quality by Design, Quality Management, Critical to Quality Factors, and risk proportionality), grounded those concepts in a working case example using Risk-Based Quality Management principles, and discussed the practical challenges teams are encountering as they translate ICH E6(R3) into protocols, processes, and day-to-day oversight. The recording and slides are available here.
The webinar is part of the MRCT Center’s broader work as the training partner for the revised ICH E6(R3) Good Clinical Practice guideline. In collaboration with the ICH E6(R3) Expert Working Group, the MRCT Center has been developing a five-module course to help sponsors, investigators, and trial teams put the modernized guideline into practice. Module 1 (Introduction and Foundational Concepts) launched in October 2025, and Module 4 (Informed Consent) followed in January 2026. Module 3 (Data Governance) and Module 5 (Essential Records) are scheduled for release this summer, with Module 2 (Responsibilities and Oversight) to follow. The full course is available through the MRCT Center training library and the ICH Training Library.
This webinar, the fourth in the MRCT Center’s AI Digital Twins and Synthetic Data series, focused on data provenance and quality, model validation, and the emerging infrastructure needed to support the clinical and regulatory adoption of these technologies. Panelists explored 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. They also discussed 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.
Panelists: Daniele Bertolini, Principal Machine Learning Scientist, Unlearn.AI | Tina Morrison, VP, Scientific Strategy, EQTY Lab | Chao-Yi Wu, Assistant Professor of Neurology, Massachusetts General Hospital
Moderator: Barbara Bierer, Faculty Director, MRCT Center
The MRCT Center, CANTRAIN, and EUPATI hosted a webinar to unveil the results of the JTF-Patient Partner Project. This collaborative effort integrated patient and caregiver expertise directly into the JTF Framework, bringing together patient partners, academic researchers, study staff, industry representatives, and others to reimagine what patient partnership within clinical research teams should entail.
The proposed update includes a supplement focused on operationalizing patient partnership in clinical research. The results are both actionable and aspirational – a blueprint for building more skilled, inclusive, and equitable research teams that generate more responsive and impactful outcomes.
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.
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.
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.
The MRCT Center has released the first three tools in the Pregnancy Privacy Protections for Participants (P4) Toolkit. These resources inform research teams, IRBs, and participants about data privacy risks if a participant becomes pregnant during a study.
Following the Dobbs decision, the changing landscape of reproductive rights in the U.S. has introduced new challenges for clinical trials, both for studies of pregnancy-related conditions and for any trial involving participants who could become pregnant. Because pregnancy testing and outcomes may be tracked during screening and throughout a trial, it is important to carefully consider how, and how well, clinical trial data can be protected, and how to communicate pregnancy privacy risks to potential and enrolled participants. These issues were explored in a MRCT Center Bioethics Collaborative forum, “Impact of Dobbs on Reproductive Health: Unintended Consequences for and on Research” and in the recent NEJM Evidence paper “Disclosure of Pregnancy-Related Privacy Risks in Clinical Research Post-Dobbs.“
The first two are directed toward clinical research teams and IRBs. The third is for research staff to adapt and share with participants; it is written in plain language and highlights terms defined in the MRCT Center’s Clinical Research Glossary. Each tool is a prototype; the introductory page instructs teams to revise content according to their specific study and local legislative and site context.
Join the MRCT Center, CANTRAIN, and EUPATI to learn the results of an effort to integrate patient partnership into the existing Joint Task Force (JTF) Framework for Clinical Trial Competency.
The initiative, entitled “JTF-Patient Partner Project (P3) – Co-Creating Clinical Research Competencies to Support Effective Patient Partner Engagement Activities,” united a representative group of patient and caregiver partners, academic researchers and study staff, industry representatives, and others, to imagine what patient partnership within the JTF Framework would cover and include.
The updates proposed in JTF-P3 include a supplementary addendum focused on integrating patient partners into the study team. The results provide a blueprint that is both operational and aspirational, supporting more skilled, inclusive, and equitable clinical research teams to achieve results faster through more responsive and impactful trials.
By the end of this webinar, attendees should be able to:
Explain what patient partners and partnerships are, and why patient partner inclusion within study teams is so important
Explain the JTF-P3 process
Describe the JTF-P3 updates to the original JTF Framework
Identify next steps in the process of meaningful patient partner integration into study teams
This webinar will be offered twice, with the same content presented by different regional panelists. One registration and one Zoom link cover both sessions. Register once and join whichever session best fits your schedule.
Session A — May 7, 9:00 AM – 10:00 AM EDT (Boston/Ottawa); 3:00 PM – 4:00 PM CEST/SAST (Brussels/Cape Town); 6:30 PM – 7:30 PM IST (New Delhi)
Session B — May 7/8 8:00 PM – 9:00 PM EDT (Boston/Ottawa); 9:00 AM – 10:00 AM JST (Tokyo, May 8); 10:00 AM – 11:00 AM AEST (Melbourne, May 8)
What does it take to deploy digital twins and synthetic data in clinical evidence generation — and what do regulators expect when you do?
In this third webinar in the MRCT Center’s Digital Twins and Synthetic Data series, a multidisciplinary panel examines the real-world application of these technologies across the clinical trial lifecycle. The discussion covers evidence quality and validation, regulatory benchmarks, model transparency, and the evolving landscape of FDA and EMA expectations. Panelists draw on experience spanning machine learning, FDA policy development, and drug development leadership to offer practical, grounded perspectives on what adoption looks like today — and where the field is headed.
Topics include:
Defining digital twins and synthetic data: key distinctions and appropriate uses
Reducing control arms and enhancing statistical power in randomized and single-arm trials
Applications across rare disease, oncology, and common conditions
Machine learning vs. traditional statistical approaches: complementary, not competing
Regulatory acceptance: FDA draft guidance, EMA qualification of PROCOVA, and engagement strategies
Model evaluation benchmarks and performance validation across development phases
Cultural and organizational barriers to adoption — and how to address them
Panelists: Daniele Bertolini, Principal Machine Learning Scientist, Unlearn.AI | Tala Fakhouri, VP Consulting AI & Digital Policy and Real World Evidence, Parexel | Karen Smith, Board Director, Context Therapeutics, Skye Bioscience, and Sangamo Therapeutics
Moderator: Barbara Bierer, Faculty Director, MRCT Center
Published in:Journal of Clinical and Translational Science
Abstract: Barbara Bierer and MRCT Center colleagues Walker Morrell, Ava Glazier, and Deborah Zarin, together with Luke Gelinas of Advarra and Tony Tse of the National Institutes of Health, published Characterization of Key Information Sections in Informed Consent Forms Posted on ClinicalTrials.gov in the Journal of Clinical and Translational Science. The 2018 revised Common Rule requires informed consent forms to open with a “concise and focused” key information (KI) section, but provides no guidance on content or format. Analyzing federally funded treatment trial ICFs posted on ClinicalTrials.gov, the authors found that three-quarters included an identifiable KI section averaging one page—yet readability showed little improvement over full ICFs, and a meaningful minority omitted core content such as the main reasons to join or not join a study. The authors call for consensus-based guidelines to help researchers and IRBs develop KI sections that are both compliant and genuinely useful to participants.
Gelinas L, Morrell W, Tse T, Glazier A, Zarin DA, Bierer BE. Characterization of key information sections in informed consent forms posted on ClinicalTrials.gov. Journal of Clinical and Translational Science. 2023;7(1):e185. doi:10.1017/cts.2023.605
