News Type: Newsletter

In the Spotlight

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Explore the MRCT Center’s On-Demand Webinar Library

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Upcoming Webinar

Deploying Digital Twins and Synthetic Data in Evidence Generation
Thursday, March 19, 1:00 – 2:00 PM ET

This webinar will examine the use of digital twins and synthetic data in evidence generation, focusing on (1) their emerging applications across the clinical trial lifecycle, including study design, and (2) regulatory expectations and experience. Panelists will discuss how evidence quality, validation approaches, performance benchmarks, and model interpretability shape decision-making, and reflect on how practical and regulatory considerations influence the adoption of these approaches in clinical research. The discussion will draw on use cases, including synthetic controls and power enhancement strategies, and will include a moderated discussion and time for audience Q&A. 

Panelists:

• Daniele Bertolini, Principal Scientist, Unlearn.AI
• Tala Fakhouri, Vice President: Consulting, AI & Digital Policy, Real-World Research, Parexel
• Karen Smith, Board of Directors at Context Therapeutics, Skye Bioscience, and Sangamo Therapeutics; Principal and Co-Founder of Boomerang Biopathways.

Moderator: Barbara Bierer, Faculty Director, MRCT Center

Related: This is the third webinar in an ongoing series focused on AI digital twins and synthetic data. Earlier webinars are available on demand:

• AI Digital Twins and Synthetic Data: Applications to Clinical Trials
• AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research

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Events & Presentations

February 6: Sarah White addressed the Clinical Research Interest Group (CRIG) at Harvard University. This group offers opportunities to explore clinical research methodologies, discuss current studies, and collaborate on projects that contribute to improving healthcare outcomes.

March 3: Sylvia Baedorf Kassis will co-lead a workshop at DIA-MASC in Boston, MA, on practical strategies for medical writers to create patient-centric materials, navigate legal and regulatory challenges, and advocate for health literacy-focused processes.

March 4: Barbara Bierer will join a panel of expert speakers at the 11th annual Research Ethics Day conference: The Future of Research Ethics: Threats and Opportunities, hosted by the University of Minnesota’s Consortium on Law and Values. For more information about the Bioethics Collaborative and how to join, click here.

March 12-13: Willyanne DeCormier Plosky and Blythe Chen will co-present “Pregnancy Privacy Protections in an Evolving Legal Landscape” at the 10^th Annual Reproductive Ethics Conference at The Hastings Center for Bioethics.

March 19, 1:00 – 2:00 PM ET: Deploying Digital Twins and Synthetic Data in Evidence Generation. See Spotlight above.

March 22-26: Sylvia Baedorf Kassis will be a featured speaker and panelist at PHUSE Connect 2026 in Austin, TX. She will be presenting on strategic approaches to involving patients and participants in the data sciences, the return of individual and study summary results, and public trust in research.

April 7: The MRCT Center and Vivli co-host an ongoing, invitation-only forum focused on the European Health Data Space (EHDS). This forum will focus on preparing for the third and last wave of TEHDAS2 consultations, continuing efforts to guide policy development toward a harmonized data-sharing system for secondary use. 

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Publications

February 10: Barbara Bierer and colleagues published a summary of their 2025 American Society for Clinical Pharmacology and Therapeutics Patient Forum panel discussion in Clinical Pharmacology and Therapeutics, highlighting actionable insights to ensure that representation in clinical trials reflects those most affected by the disease.

February 24: Barbara Bierer, Ava Glazier, and Willyanne DeCormier Plosky published “Disclosure of Pregnancy-Related Privacy Risks in Clinical Research Post-Dobbs” in NEJM Evidence. The review examines how routine clinical research practices — such as pregnancy testing, contraception requirements, and incidental pregnancy reporting — have created new privacy risks for participants, clinicians, and investigators following the 2022 Dobbs v. Jackson Women’s Health Organization decision and offers practical guidance for investigators and IRBs navigating this shifting legal landscape.

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New On-Demand Trainings

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Implementing the JTF Framework for Workforce Development: Global Use Cases

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. Through an internationally developed framework that defines the knowledge, skills, and attitudes needed for safe, ethical, high-quality research, the JTF supports organizations in strengthening roles, training, and professional development across the clinical trial ecosystem.

At the December JTF Global Biannual Meeting, speakers from 5 countries shared practical, real-world examples of how they are implementing the JTF Framework. In Pakistan, translating the framework into Urdu improved comprehension from 62% to 96% and is now informing job descriptions, investigator selection, and accreditation expectations. In the United States, the University of Cincinnati designed a master’s in clinical data science using the JTF and reduced program length while maintaining comprehensive competency coverage. North Carolina Central University developed a 4-year Clinical Research Sciences program with JTF-aligned internships. New Zealand is developing a national professional development framework to reduce role ambiguity, address workforce variability, and improve retention across public hospitals. In Australia, the REDI GROW program adopted JTF as the “backbone” and shared “international language” for a national Core Competency Framework, aimed at reducing fragmentation and workforce retention.

View the full recording for practical examples of how organizations are using the JTF Framework in education, hiring, and national workforce development.

Related: The JTF Framework is available in 13 languages. The newest translation, Urdu, was added this month. Click here for details.

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Upcoming Webinar

Deploying Digital Twins and Synthetic Data in Evidence Generation
Thursday, March 19, 1:00 – 2:00 PM ET

This webinar will examine the use of digital twins and synthetic data in evidence generation, focusing on (1) their emerging applications across the clinical trial lifecycle, including study design, control arm reduction, and single-arm trials, and (2) regulatory expectations and experience. Panelists will discuss how evidence quality, validation approaches, performance benchmarks, and model interpretability shape decision-making, and reflect on how practical and regulatory considerations influence the adoption of these approaches in clinical research. The discussion will draw on use cases, including synthetic controls and power enhancement strategies, and will include a moderated discussion and time for audience Q&A. 

Panelists:

• Daniele Bertolini, Principal Scientist, Unlearn.AI
• Tala Fakhouri, Vice President: Consulting, AI & Digital Policy, Real-World Research, Parexel
• Karen Smith, Board of Directors at Context Therapeutics, Skye Bioscience, and Sangamo Therapeutics; Principal and Co-Founder of Boomerang Biopathways.

Moderator: Barbara Bierer, Faculty Director, MRCT Center

Related: This is the third webinar in an ongoing series focused on AI digital twins and synthetic data. Earlier webinars are available on demand:

• AI Digital Twins and Synthetic Data: Applications to Clinical Trials
• AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research

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2025 Annual Symposium: Recordings now On-Demand

The MRCT Center held its Annual Symposium on October 22, 2025, hosting 100 people in Boston and 580 people virtually. Sessions focused on concrete implementation challenges in global clinical trials, including how to modernize trial operations, reduce inefficiencies, alleviate site and participant burden, reimagine informed consent as an enabling participant-centered process, and adopt the responsible use of AI. The MRCT Center Long-Term Follow-Up Toolkit was introduced (see above).

The panel recordings are now available on demand.

Keynote | John F. Crowley (BIO)

John F. Crowley, President & CEO, Biotechnology Innovation Organization (BIO)
A call for regulatory modernization, trial simplification, and cross-sector partnership to sustain innovation and expand equitable access to medicines worldwide.

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Panel | Clinical Trial Reform: The Need for Change and Progress

Kevin Bugin (Amgen); Karen Hartman (Mayo Clinic); Bridgette René McCullough (ACIRAH Health); Ann Meeker-O’Connell (Novartis)
Practical reforms to reduce protocol complexity and site burden, standardize systems, accelerate start-up, and expand patient access through adaptive and decentralized trial designs.

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Session | Meeting the Moment in an Evolving Research Environment

Sarah White, Executive Director, MRCT Center
Repositioning the MRCT Center to remain nimble and opportunistic amid regulatory, technological, and operational uncertainty through focused work on access, innovative trial design, data use and protection, patient-centered approaches, responsive forums, global capacity building, and artificial intelligence.

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Panel | Rethinking Informed Consent with Artificial Intelligence

Michael Cohen-Wolkowiez (Duke University); Megan Doerr (Sage Bionetworks); Cristin Freeman (Bristol Myers Squibb)
Real-world applications of AI to enhance informed consent, focusing on participant-centered, scalable, and feasible innovation, while respecting ethical and regulatory expectations.

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Panel | Cell & Gene Therapy Long-Term Follow-Up (LTFU): Key Deliverables and the Path Forward

Lara Gehl (Bristol Myers Squibb); Daniel Kavanagh (WCG); Pamela Tenaerts (Medable);
Practical applications of the MRCT Center’s LTFU Toolkit to harmonize data, reduce participant burden, integrate decentralized methods, and meet long-term safety and regulatory requirements.

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MRCT Center Updates | Select Initiatives

Willyanne DeCormier Plosky; Sarah White; Sylvia Baedorf Kassis; Lisa Koppelman; Barbara Bierer (MRCT Center)
Implementation updates on Representation in Research, capacity building through the TRACE Project, workforce competency standards (JTF), pediatric research, and the European Health Data Space.

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Save the date: The 2026 MRCT Center Annual Symposium will take place on Wednesday, October 21, 2026, in Boston. An agenda will be shared in the coming months.

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Events & Presentations

December 8: Meeting of the Bioethics Collaborative. Topic: How Much Risk is Too Much? Revisiting the Ethics of Control Arms. For more information about the Bioethics Collaborative and how to join, click here.

December 9: The MRCT Center hosted a webinar on “Mitigating Financial Toxicity for Participants in Clinical Trials,” in collaboration with Equitable Access to Clinical Trials (EACT), a project convened by LUNGevity Foundation. This webinar, led by Dr. Barbara Bierer (MRCT Center), Dr. David Gerber (UT Southwestern), and Wendy Selig (WSCollaborative), examined the sources and impact of these costs and highlighted emerging strategies to reduce financial hardship for research volunteers. Presenters also introduced tools, checklists, and other resources developed through the EACT Project, a collaborative forum advancing financial neutrality in clinical research participation. The recording, slides, and related resources are now available on demand here.

December 10: Joint Task Force for Clinical Trial Competency (JTF): December Global Biannual Meeting. The recording, slides, and related resources are now available on demand here.

December 13-19: Barbara Bierer and Sarah White took part in a strategic convening in Nairobi as part of the TRACE initiative, supporting Kenya’s planned participation in the TRACE Project. The meeting brought together key national authorities, including the National Commission for Science, Technology and Innovation (NACOSTI), the Pharmacy and Poisons Board (PPB), and Institutional Scientific and Ethics Review Committees (ISERCs) from Moi Teaching and Referral Hospital and the Kenya Medical Research Institute (KEMRI), alongside colleagues from Garnet Partners and the Gates Foundation. The meetings centered on advancing Kenya’s ethics and regulatory systems for clinical research. Through open and constructive dialogue, participants strengthened cross-institutional collaboration and alignment, helping to establish a foundation for more consistent, efficient, and trusted clinical research oversight under the TRACE Project. For more about the TRACE Project, click here.

January 23: Willyanne DeCormier Plosky led a discussion of the article “Excluding People With Disabilities From Clinical Research: Eligibility Criteria Lack Clarity And Justification | Health Affairs” at the most recent MGB Disability Employee Inclusion Alliance lunch-and-learn session.  

January 24: Carolyn Riley Chapman led a workshop on “What’s Special about Expanded Access for Gene and Cell Therapies?” at CUPACon26, NYU Langone Health’s Working Group on Compassionate Use & Preapproval Access (CUPA)’s biannual conference, hosted this year by Boston University School of Law.

January 29: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topics: The HALT Fentanyl Act & its effect on research involving controlled substances; Executive Order on Increasing Medical Marijuana and Cannabidiol Research and Declaration of Taipei. This meeting is open to sponsors of the Research, Development, and Regulatory Roundtable (R3). For more information about this ongoing forum and how to join, click here. 

February 6: Sarah White will address the Clinical Research Interest Group (CRIG) at Harvard University. This group offers opportunities to explore clinical research methodologies, discuss current studies, and collaborate on projects that contribute to improving healthcare outcomes.

March 3: Sylvia Baedorf Kassis will co-lead a workshop at DIA-MASC in Boston, MA, on practical strategies for medical writers to create patient-centric materials, navigate legal and regulatory challenges, and advocate for health literacy-focused processes.

March 4: Barbara Bierer will join a panel of expert speakers at the 11th annual Research Ethics Day conference: The Future of Research Ethics: Threats and Opportunities, hosted by the University of Minnesota’s Consortium on Law and Values. For more information about the Bioethics Collaborative and how to join, click here.

March 19, 1:00 – 2:00 PM ET: Deploying Digital Twins and Synthetic Data in Evidence Generation. See Spotlight above.

March 22-26: Sylvia Baedorf Kassis will be a featured speaker and panelist at PHUSE Connect 2026 in Austin, TX. She will be presenting on strategic approaches to involving patients and participants in the data sciences, the return of individual and study summary results, and public trust in research.

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Publications

November 30: The MRCT Center submitted responses to several TEHDAS2 draft guidelines to Health Data Access Bodies offered for public consultation, including one on data minimization, pseudonymization, anonymization, and synthetic data; on implementing opt-out from secondary use of electronic health data; and on notifying individuals of significant findings from the secondary use of health data. The comments highlight opportunities to refine guidance on anonymization and pseudonymization, opt-out management, and notification of significant findings, balancing operational details with scientific utility, and calls to ensure consistent and practical implementation across Member States to support EHDS in achieving its vision of a trusted and effective health data sharing framework.

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In the Spotlight

New Toolkit for Long-Term Follow-Up

In early November, the MRCT Center released the Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up Studies as a draft for public comment. The resource offers practical, actionable guidance for best practices across long-term follow-up (LTFU) studies for both investigational and approved gene therapies, balancing the need to generate essential long-term safety and efficacy data with the obligation to reduce burden on participants, caregivers, sponsors, and investigators. Its interactive structure—with clickable toolbars, intuitive navigation, and clearly organized sections spanning Guiding Principles, Types of LTFU Studies, Considerations and Recommendations, Key Design Elements for FDA-approved products, regulatory references, glossaries, and appendices—helps users move quickly from concept to implementation.

Stakeholders have emphasized the value of the toolkit’s pragmatic approach. They highlighted its emphasis on engaging patients as partners and ambassadors; applying the Goldilocks principle to right-size expectations; embedding patient-centricity into every stage; and using decentralized approaches when appropriate. They also praised its attention to adaptability, recognizing that program adjustments over time are expected, and its thoughtful integration of real-world data. Importantly, the toolkit encourages teams to consider not only disease-specific factors but also the needs and contexts of patient communities, families, advocacy groups, and global treatment environments.

The Toolkit remains open for public comment. Please share your feedback by Friday, December 19, by emailing us at mrct@bwh.harvard.edu

Explore the Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up Studies and watch the on-demand toolkit release webinar.  

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EC/IRB Guide to Understanding Post-Trial Continued Access

In early November, the MRCT Center released the EC/IRB Guide for Understanding Post-Trial Continued Access, which aims to assist Ethics Committees (EC) and Institutional Review Boards (IRB) in interpreting their role under Paragraph 34 of the Declaration of Helsinki. Paragraph 34 requires sponsors and researchers to arrange post-trial provisions for “participants who still need an intervention identified as beneficial and reasonably safe.” Exceptions to this must be approved by an EC or IRB, necessitating an understanding of when post-trial, continued access is applicable.

This resource outlines principles and criteria for evaluating when continued access is appropriate. It provides tools and questions to guide equitable decisions, ensuring ethical and transparent approaches to post-trial, continued access decisions. Additional resources and frameworks are available through the MRCT Center’s Post-Trial Responsibilities: Continued Access project page to support ethics committees.

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Implementing the MRCT Center’s Clinical Research Glossary

Many organizations are integrating the MRCT Center’s Clinical Research Glossary into their workflows, demonstrating its practical value in improving communication and participant understanding. Across seven published use cases, including two new ones from Pfizer and Biogen, learn more about how the glossary’s 216 plain-language terms, definitions, images, and linked resources are being used to strengthen patient-facing materials, support health-literacy training, and align technical content with global data standards.

These real-world examples underscore the glossary’s impact: clearer explanations, greater confidence among participants and caregivers, and more consistent communication across research teams. 

As the glossary continues to grow through annual public review, we invite you to consider how a shared, plain-language vocabulary can advance informed decision-making and more equitable engagement in clinical research. To learn more about the Clinical Research Glossary, get involved, or submit your own use case, please click here. 

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Upcoming Webinars and Forums

Mitigating Financial Toxicity for Participants in Clinical Trials
Tuesday, December 9 | 10:00–11:00 AM ET

Hosted by the MRCT Center, in collaboration with Equitable Access to Clinical Trials (EACT), a project convened by LUNGevity Foundation.

Clinical trials are vital to advancing medical knowledge and care, yet participation can impose significant financial burdens on participants and their families—from travel and time away from work to uncovered medical and ancillary expenses.

This webinar will examine the sources and impact of these costs and highlight emerging strategies to reduce financial hardship for research volunteers. Presenters will also introduce tools, checklists, and other resources developed through the EACT Project, a collaborative forum advancing financial neutrality in clinical research participation.

Panelists

• Dr. David Gerber, Co-Director, Simmons Comprehensive Cancer Center Office of Education and Training; Professor, University of Texas Southwestern Medical Center
• Wendy K.D. Selig, Founder and CEO, WSCollaborative

Moderator
Dr. Barbara Bierer, Faculty Director, MRCT Center

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Joint Task Force for Clinical Trial Competency (JTF): December Biannual Global Meeting
December 10, 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—the knowledge, skills, and attitudes—needed to conduct safe, ethical, high-quality clinical research.

Join us on December 10, from 1:00–3:00 PM ET, for the JTF Biannual Global Meeting to learn from colleagues around the world who are implementing the JTF Framework in diverse contexts. Presentations will highlight how the Urdu translation of the Framework is advancing clinical research competencies in Pakistan; how professional standards and recognition are being strengthened for Australian clinical trials professionals; and how workforce development is being supported across New Zealand public hospitals. Speakers will also share approaches to designing experiential learning with a focus on JTF competencies at North Carolina Central University, as well as efforts to integrate the Framework into a master’s-level clinical data science training program. 

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Deploying Digital Twins and Synthetic Data in Evidence Generation
Thursday, January 15, 11:00 AM to 12:00 PM ET.

Please join us on Thursday, January 15, for the third webinar in the MRCT Center’s Digital Twins and Synthetic Data series. This session will examine the appropriate use of digital twins and synthetic data in evidence generation, including their potential role in regulatory submissions.

Panelists will discuss evidence quality, validation, and model transparency, and will reflect on the evolving regulatory landscape for these technologies in clinical research. The session will include a moderated discussion and time for audience Q&A.

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Events & Presentations

November 4: Long-Term Follow-Up for Gene Therapies: Toolkit Release webinar. Resources from this webinar, including the Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up Studies, the recording, slides and related resources, are now available on-demand here.

November 4: The MRCT Center and Vivli co-host an ongoing, invitation-only forum focused on the European Health Data Space (EHDS). The discussion continues with stakeholders collaborating on developments and the coordination of work efforts. The November forum, the fifth to date, focused on responses to the TEHDAS2 guidance documents in the form of public consultation in key identified areas, and continued our efforts to guide policy development towards a harmonized data sharing system for secondary use purposes.

November 7-8: The MRCT Center at the PRIM&R 2025 Conference:

November 14: Sylvia Baedorf Kassis was a speaker at the International Society for Medical Publication Professionals (ISMPP) Academy. She co-led interactive sessions on Mastering Plain Language Summaries (PLS) and Plain Language Summaries of Publications (PLSP): Bridging Foundations and Applications.

November 17 and 19: Barbara Bierer conducted a 2-day, 6-hour virtual training with medical professionals from St. Luke’s Medical Center of the Philippines to introduce participants to the purpose and functioning of Data Safety Monitoring Committees (DSMCs). On the second day of the virtual training, Steven Snapinn, Ph.D., presented on biostatistical considerations for DSMC, a discussion moderated by Dr. Bierer.

November 18: AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research. This webinar, the second in this series, focused on real-world examples and lessons learned from deploying synthetic data and digital twins across therapeutic areas. Resources, including the recording, slides, and related resources, are now available on-demand here.

November 18: Carolyn Riley Chapman presented an overview of the MRCT Center’s Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up Studies for Gene Therapies at the WCG-hosted webinar Beyond the Trial: Ethical Oversight in Gene Therapy Long-Term Follow-Up.

November 19: Barbara Bierer addressed “Resources for PI oversight in decentralized clinical trials” at the Innovation Evidence Workshop, a full-day meeting in Boston, presented by Medable in collaboration with Tufts Center for the Study of Drug Development at Tufts University School of Medicine. 

December 8, 10:00 AM – 12:30 PM: Meeting of the Bioethics Collaborative. Topic: How Much Risk is Too Much? Revisiting the Ethics of Control Arms. For more information about the Bioethics Collaborative and how to join, click here.

December 10, 1:00 – 3:00 PM ET: Joint Task Force for Clinical Trial Competency (JTF): December Biannual Global Meeting. See Spotlight above.

December 15-18: Dr. Barbara Bierer and Sarah White will be visiting Kenya as the fifth country in the TRACE project. Their itinerary includes meetings with the TRACE leadership team and key stakeholders within Kenya, including KEMRI, NACOSTI, PPB, and Moi University’s IRB. This baseline assessment will focus on regulatory and ethics systems coordination and optimization, capacity buildng and training needs, as well as an introduction to the WHO Ethics Benchmarking tool and financial sustainability models.

January 15, 11:00 AM – 12:00 PM ET: Deploying Digital Twins and Synthetic Data in Evidence Generation. See Spotlight above for details.

January 24: Carolyn Riley Chapman will co-lead a workshop on “What’s Special about Expanded Access for Gene and Cell Therapies?” at CUPACon26, NYU Langone Health’s Working Group on Compassionate Use & Preapproval Access (CUPA)’s biannual conference, hosted this year by Boston University School of Law. This workshop will be led in collaboration with Dr. Emma James of Encoded Therapeutics.

January 29: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topics: The HALT Fentanyl Act and its effects on research involving controlled substances; Declaration of Taipei. This meeting is open to sponsors of the Research, Development, and Regulatory Roundtable (R3). For more information about this ongoing forum and how to join, click here. 

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Publications

November 14: Carolyn Chapman, Mena Shaikh, Ava Glazier, Andrew Creamer, and Barbara Bierer published Ethical, Legal, and Social Issues (ELSI) in Human Somatic Gene Therapy Clinical Research: A Scoping Review in Human Gene Therapy. Dozens of gene therapies have been approved, and hundreds more are in development, prompting the need to better characterize the ethical, legal, and social implications (ELSI) of this emerging therapeutic class. The authors conducted a scoping review to map these issues across the literature, identifying themes related to risk–benefit assessment, engagement and communication, justice and access, ethical trial design, and the influence of financial and regulatory decision-making. The article also discusses potential approaches to address these ELSI as gene-therapy research expands.

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MRCT Center Updates

Nandini Krishnamoorthy joined the MRCT Center as a Student Researcher in November 2025. Nandini will be providing support to various projects at the Center. 

Nandini is a senior at Tufts University, studying Community Health. Across academic and professional experiences spanning clinical, academic, and community-based settings, Nandini has worked toward a commitment to advancing health equity at the intersection of clinical medicine, global health, and community-based research. 

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In the Spotlight

New ICH E6(R3) Training

The ICH E6(R3) Guideline for Good Clinical Practice (GCP) modernizes global standards for the ethical and scientific conduct of clinical trials.

To support its interpretation and implementation, the MRCT Center, in collaboration with the International Council for Harmonisation (ICH), is designing and developing a five-module course. The first module, Introduction and Foundational Concepts, has been released on the ICH Training Library and provides a clear orientation to the structure and intent of the Guideline—its principles, annexes, and appendices—and introduces foundational concepts such as quality by design, quality management, critical-to-quality factors, risk proportionality, and fit-for-purpose.  This free, self-paced training is designed for investigators and their research teams, providers, sponsors, contract research organizations, IRB/IEC members, and regulators involved in interventional clinical research. Four additional modules are in development and will expand on key sections of the E6(R3) Guideline. The MRCT Center is an ICH Training Associate.  

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Upcoming Webinars

October 30, 12:00 – 1:00 PM ET: Applied Health Literacy: Using Teach-Back in Clinical Research

October is Health Literacy Month! Join us on Thursday, October 30, for the webinar Applied Health Literacy: Using Teach-Back in Conversations About Clinical Research.

Learn the essential elements of Teach-Back, why it matters for safe, equitable care and research, and practical ways to integrate it into clinical research conversations. The session will highlight how study teams can simplify complex information, confirm understanding, and foster dialogue with participants and caregivers throughout recruitment, consent, and beyond.

Registrants will receive tips and resources to apply Teach-Back in everyday research processes.

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November 4, 11:00 AM – 12:00 PM ET: Long-Term Follow-Up for Gene Therapies: Toolkit Release

Join us as we mark the public release of the Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up Studies for Gene Therapies. Developed with multi-stakeholder input from industry, academic researchers, patients, patient advocates, and human research protection professionals, the Toolkit provides practical guidance to employ best practices to design and operationalize LTFU studies for both investigational and approved gene therapies.

The session will introduce the Toolkit’s structure and contents, including Guiding Principles, Considerations and Recommendations, and Looking Forward sections. The Toolkit also features other resources, such as key design elements of LTFU studies for FDA-approved gene therapies, international LTFU regulatory guidance, glossaries, and background information on types of LTFU studies.

We will be joined by three panelists who will share their experiences and perspectives and highlight key points and takeaways. There will be time for Q&A with the audience as well.

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November 18, 12:00 pm- 1:00 pm ET: AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research

This second session in our AI series will focus on real-world applications of digital twins and synthetic data in clinical research. Daniele Bertolini, Unlearn.AI, will discuss how these technologies can reduce reliance on traditional control arms, support Bayesian and single-arm trial designs, and optimize future trial planning and analysis.

The session will also examine emerging opportunities and limitations in applying AI-enabled models to clinical trials and how these approaches may advance trial efficiency and innovation in study design.

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December 10, 1:00 pm – 3:00 pm: Joint Task Force for Clinical Trial Competency (JTF): December Biannual Global Meeting

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—the knowledge, skills, and attitudes—needed to conduct safe, ethical, high-quality clinical research.

Join us on December 10, from 1:00–3:00 PM ET, for the JTF Biannual Global Meeting to learn from colleagues around the world who are implementing the JTF Framework in diverse contexts. Presentations will highlight how the Urdu translation of the Framework is advancing clinical research competencies in Pakistan; how professional standards and recognition are being strengthened for Australian clinical trials professionals; and how workforce development is being supported across New Zealand public hospitals. Speakers will also share approaches to designing experiential learning with a focus on JTF competencies at North Carolina Central University, as well as efforts to integrate the Framework into a master’s-level clinical data science training program. 

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New Resource for Financial Neutrality in Cancer Trials

The MRCT Center has been part of a collective effort to advance financial neutrality for participants in cancer clinical trials by ensuring that financial support for out-of-pocket patient costs is available. This effort, the Equitable Access to Clinical Trials (EACT) initiative, involves a multi-stakeholder group of patient advocacy organizations, clinical trial site leaders, industry partners, CRO, and IRB colleagues.

A new resource, Advancing Equitable Access to Clinical Trials: Eliminating the Financial Burden for Patients, has been released. This document provides important information, recommendations, and a Call to Action for site personnel to advance financial neutrality in cancer trials.

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Events & Presentations

September 11: The MRCT Center’s Artificial Intelligence (AI) and Ethical Research project continues to advance practical guidance for the responsible use of AI in clinical research, anchored by the Framework for Review of Clinical Research Involving Artificial Intelligence. Building on this work, WCG—our collaborator in developing the Framework—hosted a September 11 webinar with Barbara Bierer and Trevor Baker to demonstrate how the Framework can be applied in real-world review and oversight scenarios. Following the session, WCG released a new FAQ to support stakeholders in interpreting and operationalizing the Framework.

September 30: AI Digital Twins and Synthetic Data: Applications to Clinical Trials. The recording, slides, and related resources are now available on demand.

September 30: The MRCT Center and Vivli co-host an ongoing, invite-only forum focused on the European Health Data Space (EHDS), bringing together stakeholders to track developments and coordinate responses. This convening, the fourth in the series to date, prioritized upcoming TEHDAS2 guidance documents for public consultation and developed a strategy for collective feedback and submissions.

October 7: Sarah White joined Jane Williams and Meredith Wilson of Syneos Health, and Kemi Olugemo of Korro Bio, for the panel “Ethics in Action: Building Patient Protection in Clinical Trials Through Therapeutic Expertise” at the Fierce Biotech conference in Boston.

October 22: MRCT Center Annual Symposium. The MRCT Center convened global research stakeholders, both in-person in Boston and online, for its one-day Annual Symposium, “Meeting the Moment,” to advance ethical, actionable, and practical solutions for global clinical trials. John Crowley, President & CEO of the Biotechnology Innovation Organization (BIO), delivered the keynote, setting the stage for discussions on the need for clinical trial reform, rethinking informed consent with artificial intelligence, long-term follow-up for cell and gene therapies, and the path forward for participant-centered innovation. The program concluded with an interactive session on reinventing informed consent, inviting attendees to collaboratively reimagine the consent form and process for today’s research landscape.

October 23: Vivli Annual Meeting, co-hosted with the MRCT Center. “Data in Action: From Contribution to Impact.”

October 24: Trevor Baker, Barbara Bierer, and WCG collaborator Donna Snyder presented “Ethical Oversight of AI in Clinical Research: A Framework and Practical Implications” at the MAGI@home virtual conference. 

October 30, 12:00 – 1:00 PM ET: Applied Health Literacy: Using Teach-Back in Clinical Research. See Spotlight above

November 4, 11:00 AM – 12:00 PM ET: Long-Term Follow-Up for Gene Therapies: Toolkit Release Webinar. See Spotlight above.

November 4: The MRCT Center and Vivli co-host an ongoing, invitation-only forum focused on the European Health Data Space (EHDS). The discussion continues with stakeholders collaborating on developments and the coordination of work efforts. The November forum, the fifth to date, will focus on responses to the TEHDAS2 guidance documents in the form of public consultation in key identified areas, and continue our efforts to guide policy development towards a harmonized data sharing system for secondary use purposes.

November 7-8: The MRCT Center at the PRIM&R 2025 Conference:

November 14: Sylvia Baedorf Kassis will be a speaker at the International Society for Medical Publication Professionals (ISMPP) Academy. She will be co-leading interactive sessions on Mastering Plain Language Summaries (PLS) and Plain Language Summaries of Publications (PLSP): Bridging Foundations and Applications.

November 18, 12:00 pm- 1:00 pm ET: AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research. See Spotlight above.

December 8, 10:00 AM – 12:30 PM: Meeting of the Bioethics Collaborative. Topic: How Much Risk is Too Much? Revisiting the Ethics of Control Arms. For more information about the Bioethics Collaborative and how to join, click here.

December 10, 1:00 – 3:00 PM ET: Joint Task Force for Clinical Trial Competency (JTF): December Biannual Global Meeting. See Spotlight above.

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Publications

October 16: In the article, A Scoping Review of Challenges in Pediatric Health Technology Assessments with a Focus on Pharmaceutical Interventions, published in the International Journal of Technology Assessment in Health Care,  authors Nora Hutchinson, Lauren Otterman, Elisa Koppelman, Barbara Bierer, and colleagues highlight the substantial difficulties in incorporating children within the population-wide health technology assessment (HTA) system, as well as the uncertainty accompanying pediatric HTAs due to data constraints, lack of guidance and/or variation in guidance, between HTA bodies.

October 22: In the article “Characteristics of long-term follow-up studies for gene therapies registered on ClinicalTrials.gov,” published in Gene Therapy, co-authors Carolyn Chapman, Emina Berbic, Ava Glazier, and Barbara Bierer describe key characteristics of LTFU gene therapy study protocols registered in ClinicalTrials.gov. Analyzing how registered LTFU studies are currently designed, the results suggest a lack of harmonization in how safety outcomes are monitored and reported across LTFU studies. Standardization and/or harmonization of data and outcome reporting may increase the scientific value of these studies.

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In the Spotlight

JOIN US! MRCT Center 2025 Annual Symposium

Join us for a full day of discussions and presentations on ethical, actionable, and practical solutions to today’s global clinical research challenges. Engage with regulators, industry leaders, patient advocates, and research experts to gain privileged insights, shape the conversation, and forge connections that drive real-world impact. The symposium is free and open to all registrants.

We are pleased to announce our keynote speaker: John Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), a biotechnology advocacy organization representing biotech companies, industry leaders, and state biotech associations in the United States and more than 35 countries around the globe. John’s decades of biotech experience and deep passion for the field have made him a strong supporter of policies that empower innovation, enable entrepreneurship, and put people and patients first.

Other highlights of the agenda include the following:

• Rethinking Informed Consent with Artificial Intelligence: Opportunities and Challenges
• Cell and Gene Therapies Long-Term Follow-Up: Key Deliverables and the Path Forward
• Reinventing Informed Consent: Emerging from the Chrysalis  
• Clinical Trial Reform: The Need for Change and Progress

On Thursday morning, October 23, the MRCT Center will hold a joint meeting in concert with the Vivli annual meeting. Researchers, data contributors, and funders will discuss the journey from data contribution to impact in clinical trial methodology, oncology, and Type 1 diabetes. Sessions will focus on learnings from data challenges, the latest in sharing imaging data, as well as how to apply the latest DOJ ruling on sharing data with countries of concern.  This event is also complimentary and open to all Symposium registrants.

Register today to secure your spot and help drive responsible innovation in clinical trials.

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The Clinical Research Glossary: Now Expanded to 216 Words

The MRCT Center’s Clinical Research Glossary helps participants, patients, and care partners make informed decisions about clinical research by explaining complex terms in clear, plain language. Everyone—regardless of background—has the right to understand, ask questions, and fully engage in the research process. The glossary also supports research professionals in fostering clear, meaningful dialogue with participants throughout a study.

In collaboration with CDISC, we’ve added 29 new terms. The glossary now includes 216 terms, definitions, images, and related content, and is freely accessible under a Creative Commons license. Click here for an updated FAQ with a Summary of Changes.

Explore, download, and share the glossary—and help make clinical research clearer for all. Submit feedback or suggest additional terms here.

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Upcoming Webinars

October 30, 12:00 PM – 1:00 PM ET: Applied Health Literacy: Using Teach-Back in Clinical Research

Learn the essential elements of Teach-Back, why it matters for safe, equitable care and research, and practical ways to integrate it into clinical research conversations. The session will highlight how study teams can simplify complex information, confirm understanding, and foster dialogue with participants and caregivers throughout recruitment, consent, and beyond.

Registrants will receive tips and resources to apply TB in everyday research processes.

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November 4, 11:00 AM – 12:00 PM ET: Long-Term Follow-Up for Gene Therapies: Toolkit Release

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.

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In the Spotlight

JOIN US! MRCT Center 2025 Annual Symposium

Join us for a full day of discussions and presentations on ethical, actionable, and practical solutions to today’s global clinical research challenges. Engage with regulators, industry leaders, patient advocates, and research experts to gain privileged insights, shape the conversation, and forge connections that drive real-world impact. The symposium is free and open to all registrants.

We are pleased to announce our keynote speaker: John Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), a biotechnology advocacy organization representing biotech companies, industry leaders, and state biotech associations in the United States and more than 35 countries around the globe. John’s decades of biotech experience and deep passion for the field have made him a strong supporter of policies that empower innovation, enable entrepreneurship, and put people and patients first.

Other highlights of the agenda include the following:

• Rethinking Informed Consent with Artificial Intelligence: Opportunities and Challenges
• Cell and Gene Therapies Long-Term Follow-Up: Key Deliverables and the Path Forward
• Reinventing Informed Consent: Emerging from the Chrysalis  
• Clinical Trial Reform: The Need for Change and Progress

On Thursday morning, October 23, the MRCT Center will hold a joint meeting in concert with the Vivli annual meeting. Researchers, data contributors, and funders will discuss the journey from data contribution to impact in clinical trial methodology, oncology, and Type 1 diabetes. Sessions will focus on learnings from data challenges, the latest in sharing imaging data, as well as how to apply the latest DOJ ruling on sharing data with countries of concern.  This event is also complimentary and open to all Symposium registrants.

Register today to secure your spot and help drive responsible innovation in clinical trials.

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New Project: Reproductive Health Considerations in Clinical Research

The Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization introduced new challenges for the conduct of clinical trials involving people of reproductive potential, for the study of pregnancy-related conditions, and for participants in clinical research and research staff. Among other concerns, the legislation—and the patchwork of state laws that followed—has introduced new privacy concerns for clinical trial participants and others. The MRCT Center is using both empirical and normative approaches to frame new recommendations and a practical toolkit for improved practices in research.

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September Webinars

September 12: Continued Access to Investigational Products: Guiding Equitable and Fair Decisions

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 addressed before the trial begins. Even with the best planning, complex situations 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.

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September 30: AI Digital Twins and Synthetic Data: Applications to Clinical Trials

Please join us on Tuesday, September 30, 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 are 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 reduce 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 being developed for use in the design, conduct, and analysis of clinical trials, with potential applications in regulatory submissions. This webinar will introduce these emerging technologies and explore their implications, opportunities, and challenges in clinical research.

Key Topics:

• Overview of digital twins and synthetic data, including how they differ from traditional statistical modeling.
• Ethical, statistical, and regulatory considerations for adopting these technologies in clinical trial design and conduct.
• Panel discussion with expert perspectives on the evolving role of AI digital twins and synthetic data in clinical research.

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In the Spotlight

Framework for Review of Clinical Research Involving Artificial Intelligence (AI)

As part of the MRCT Center’s AI and Ethical Research project, the Framework for Review of Clinical Research Involving AI was co-developed by the MRCT Center and WCG, in collaboration with a diverse, multi-stakeholder task force. This resource offers institutional review boards (IRBs) and other oversight entities a structured, practical approach to evaluating protocols that involve artificial intelligence in research with human participants. The framework addresses emerging ethical and regulatory challenges specific to AI—such as algorithmic bias, adaptive learning, data identifiability, and the need for human oversight—while aligning with foundational ethical principles and applicable U.S. regulations. Through tools including a decision tree for regulatory applicability, stage-specific review guidance, and targeted ethical considerations, the framework supports consistent, thorough review processes that protect participants and promote the responsible use of AI in clinical research.

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Introducing TRACE: Trial Regulatory and Clinical Ethics Optimization 

The TRACE project is a dynamic initiative to strengthen and streamline clinical trial regulatory and ethics systems across Africa.

Despite growing interest in African clinical research, sponsors still encounter unclear submission pathways, manual or outdated systems, redundant reviews, and unpredictable timelines, all barriers TRACE aims to eliminate.

The initiative’s initial focus on Rwanda, Tanzania, Zimbabwe, and Nigeria drives regulatory optimization, ethics systems strengthening, and regional capacity building to create transparent, predictable, and efficient review processes that attract more trials to the region.

Dr. Barbara Bierer has recently completed a series of country visits to support TRACE’s core priorities. Between April and June, she visited Nigeria, Rwanda, Zimbabwe (with Sarah White), and Tanzania. Working closely with national partners, these visits focused on assessing current national ethics review systems, introducing the WHO’s tool for benchmarking ethics oversight, and identifying collaborative long-term strategies for financial sustainability. By working directly with local stakeholders, TRACE is supporting country-led solutions that will evolve throughout the project and help align practices with global standards.

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On-Demand Webinars and Resources

Your Voice, Global Impact: Join the Clinical Research Glossary’s Annual Public Review Process
This on-demand webinar, presented on June 24, provided an overview of the MRCT Center’s Clinical Research Glossary—a plain-language reference defining 187 clinical research terms, with 30 new terms open for public comment through July 5. It detailed the feedback submission process to ensure accuracy and inclusivity and underscored the significance of this input in advancing adoption as a CDISC global standard, empowering participants to make informed decisions. The recording, presentation slides, and related materials are now available.

A Framework for AI Adoption and Oversight in Clinical Research
As discussed above, this on-demand webinar, also presented on June 24, introduces a structured framework to support institutional review boards and sponsors in the ethical oversight of clinical research protocols involving artificial intelligence. The webinar includes an overview of the framework’s development, key considerations for risk-benefit analysis, and practical tools to guide decision-making. The recording, presentation slides, and related materials are now available.

Patient-Centered Long-Term Follow-Up for Gene Therapies
This on-demand webinar, presented on June 26, examines the FDA’s recommendations for long-term safety monitoring of gene therapy recipients—recognizing both the transformative benefits and potential health risks—and highlights the critical need to design follow-up studies around patient needs and preferences to minimize burdens. Building on prior discussions of platform trials and registries, this webinar emphasizes strategies to reduce burden and enhance participant-centered practices. Perspectives include insights from a foundation tackling patient loss to follow-up, expertise on embedding patient-centric culture change into study design, and a patient advocate’s lived experience emphasizing the power of patient voices in shaping compassionate, sustainable LTFU frameworks. The recording, presentation slides, and related materials are now available.

Biannual Meeting of the Joint Task Force for Clinical Trial Competency
The slides and Executive Summary from the June 2 biannual global meeting of the Joint Task Force for Clinical Trial Competency (JTF) are now available.

Topics:

• Integrating JTF Competencies: Curriculum Design and Accreditation at Arizona State UniversityComprehensive leveling of the Clinical Research Professional Career Ladder at Johns Hopkins University
• 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

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