In the Spotlight
Join Us for the MRCT Center’s Annual Symposium in Boston!
Mark your calendar for November 13-15, 2024, to attend a compelling three-day symposium featuring dynamic presentations and discussions. The first day is open to Executive and Steering Committee (EC/SC) sponsors. The annual two-day event that follows is open to all registrants at no cost. While we encourage in-person attendance, virtual participation is welcome.
Wednesday, November 13 – open to EC/SC sponsors: The day will begin with a meeting with the Post-Trial Responsibilities – Continued Access to Investigational Products working group, followed by lunch and the EC/SC meeting.
Thursday, November 14 – open to the public at no charge:
The day will feature a keynote address by Dr. Khair ElZarrad, Director of the Office of Medical Policy at the FDA, as well as presentations on the MRCT Center’s recent and upcoming work, breakout sessions, and a cocktail reception. Panel discussions will include AI – Synthetic Data and Digital Twins; Post-trial, Continued Access to Investigational Medicines and Devices; and Impacts of Revisions to the Declaration of Helsinki.
Friday, November 15 – open to the public at no charge: Vivli, the Center for Global Clinical Research Data, in conjunction with the MRCT Center, will host “Innovations in Data Sharing,” a half-day program featuring Dr. Steffen Thirstrup from the European Medicines Agency (EMA).
Click the link below to learn more about the agenda and to register for some or all events.
Upcoming Events: Health Literacy Month Webinar Series
Join us for three engaging and informative webinars to celebrate Health Literacy Month. These sessions will provide practical tools and foster robust discussions, benefiting anyone interested in incorporating health literacy and accessibility best practices into communicating participant-facing clinical research information. We encourage you to join all three sessions! You can register for each webinar below.
October 10, 12 – 1 pm ET: Session 1: Designing Impactful Informed Consent Processes that Empower Participants
October 17, 12 – 1 pm ET: Session 2: Creating and Sharing Plain Language Summaries: One Team’s Experience
October 22, 12 -1 pm ET: Session 3: Designing PowerPoint Presentations to Support Health Literacy and Accessibility
The Clinical Research Glossary: Now Expanded to 187 Words
The MRCT Center’s Clinical Research Glossary plays a vital role in promoting health literacy by providing clear and accessible definitions of complex research terms. This resource empowers all research participants, patients, and the broader public to make informed decisions about their involvement in clinical research. It ensures that everyone, regardless of background, can grasp critical concepts, ask informed questions, and fully engage in the research process.
Additionally, research professionals can use the glossary to communicate complex ideas in plain language, helping participants better understand study objectives, procedures, and risks and supporting meaningful dialogue.
In collaboration with CDISC, we added twenty new terms based on valuable input from the clinical research community. The newly expanded Clinical Research Glossary now includes 187 research terms, definitions, images, and related content, and is freely accessible under the terms of our Creative Commons license. We’ve also updated the Frequently Asked Questions section, including a Summary of Changes.
We encourage you to explore this vital resource, download it, and share the glossary within your networks.
If you’d like to suggest new terms or provide feedback, please use this form.
Join Us: December Biannual Meeting of the Joint Task Force for Clinical Trial Competency
The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, is dedicated to developing and disseminating standards and practices for the clinical research workforce. The JTF fosters a cohesive, global approach to ensuring that professionals have the necessary competencies to conduct clinical trials effectively and ethically.
The public is invited to attend virtual biannual meetings. The next meeting is December 10 from 9 – 11 AM ET. Proposed updates include Delphi results from the data management task force, the launch of a patient-centric competencies task force, proposed team science competencies, the Portuguese translation, application of the results from the JTF competency survey in the Philippines, and training community workers using the JTF framework.
Click here to register.
Mansfield-PhRMA Research Scholars at MRCT Center
On September 16, eight scientists and clinical researchers from hospitals and universities across Japan, three government officials from PMDA, AMED, and METI, and three staff members from the Maureen and Mike Mansfield Foundation in Washington, DC, visited the MRCT Center. Sarah White presented about the work of the MRCT Center, and Rebecca Li presented about Vivli and engaged in discussions with the scholars.
From September 14-21, Barbara Bierer attended the semi-annual meetings of the Technical Coordinating Committee and the Advisory Committee of the African Vaccine Regulatory Forum (AVAREF). In addition and in collaboration with WHO, she hosted a multi-day ethics training for national ethics committee members and chairs across Africa.
Events & Presentations
September 23: Carolyn Chapman served on a panel on Community Engagement and Accessibility at the Rosamund Stone Zander Translational Neuroscience Center (RSZ TNC) at Boston Children’s Hospital’s fifth research symposium entitled Paving the Path: Therapeutic Development Readiness for Rare Neurogenetic Disorders.
September 29-30: Sylvia Baedorf Kassis spoke at the Society for Clinical Data Management (SCDM) conference in Boston. On Sunday, September 29, she presented at the SCDM Leadership Forum, discussing how industry leaders can collaborate to simplify the clinical trial journey for patients and sites. On Monday, September 30, she participated in a panel focused on incorporating site and patient voices in decentralizing clinical trial activities. For both sessions, she was joined by Marilyn Neault, PhD, a Patient Advocate for Research and long-time co-leader of the MRCT Center Clinical Research Glossary workgroup.
October 8: Carolyn Chapman will present on the “Protection of Human Research Participants” at the American Association for Cancer Research (AACR)’s workshop on Translational Cancer Research for Basic Scientists.
October 8, 12:00 pm ET: Willyanne DeCormier Plosky will present with Zary Amirhosseini (Program Manager, MGH Disability Program), Martha Jones (Vice President, MGB Human Research Affairs), and Jeanhee Chung (Principal Investigator, MGH Lab of Computer Science; Instructor in Medicine, Harvard Medical School) on “Empowering Voices: Strategies for Involving Individuals with Disabilities in Research.” This webinar is part of the Chester Pierce Research Society Speaker Series.
October 8: Hayat Ahmed will participate in a Clinical Trial Diversity Roundtable hosted by Congresswoman Robin Kelly (IL), Chairwoman of the Congressional Black Caucus (CBC) Health Braintrust, at the La Rabida Children’s Hospital in Chicago.
October 10, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 1: Session 1: Designing Impactful Informed Consent Processes that Empower Participants
October 10: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topics: 1) Laboratory Developed Tests, and 2) Limitations on Sharing Data with China and Other Countries of Concern
October 10, 8 am – 4:30 pm ET: Dr. Barbara Bierer and Mark Barnes will be featured as panelists at the “Advancing Trust in Science: Institutional Obligations to Promote Research Integrity,” a hybrid event hosted by the Department of Medical Ethics & Health Policy and the Institute for Translational Medicine & Therapeutics: University of Pennsylvania Perelman School of Medicine.
October 15, 12:00 pm ET: Willyanne DeCormier Plosky will present at the SCRS IncluDE Site Summit follow-up webinar titled “IncluDE Encore: Inclusivity Forum for People with Disabilities.”
October 17, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 2: Creating and Sharing Plain Language Summaries: One Team’s Experience
October 21, 11:00 am ET: Willyanne DeCormier Plosky will present at Penn State College of Medicine/ Penn State Clinical & Translational Science Institute on “Mapping the Participant Journey: Disability Inclusion in the Research Process.”
October 22, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 3: Designing PowerPoint Presentations to Support Health Literacy and Accessibility
Oct 31-Nov 1: Willyanne DeCormier Plosky will deliver a keynote speech at the University of Monterrey (Mexico) 2nd International Symposium on Medical Education. The keynote title is “Gender Perspectives and Inclusion: Key Elements in Transforming Medical Education for a Future of Personalized and Safe Care.”
Nov 13 – 15: MRCT Center Annual Symposium. Click here to learn more about the agenda and to register.
November 15, 9 am – 2 pm ET: Vivli Annual Meeting, in conjunction with the MRCT Center: “Innovations in Data Sharing.” Keynote with Dr. Steffen Thirstrup of the European Medical Association (EMA). Click here to register for this event solely or for all MRCT Center Annual Symposium events.
The MRCT Center at PRIM&R Annual Conference:
- November 18, 12:30 – 1:30 pm PT: Barbara Bierer and REACH Collaborative colleagues Michelle Feige (AAHRPP), Ivy Tillman (PRIM&R), Martha Jones (Mass General Brigham) will present “REACH: the Research Ethics Collaborative for HRPPs for Justice.”
- November 18, 1:45 – 3:00 pm PT: Barbara Bierer and Benjamin Silverman (Mass General Brigham) will present “Accessing Capacity to Consent for Research Participation: When and How Do You Actually Do It?”
- November 19, 10:30 – 11:45 am PT: Willyanne DeCormier Plosky will join Sarah Muenster-Blakeley (University of St. Thomas) and Cecilia Brooke Cholka (Weill Cornell Medicine) to present “Accessibility Basics: Making Word Documents and Videos Accessible.”
- November 19: 1:45 – 3:00 pm PT: Barbara Bierer and Adam Berger (NIH) will present “Building Trust in Science: Enabling Frameworks for Returning Individual Research Results to Research Participants.”
- November 19, 1:45 – 3:00 pm PT: Willyanne DeCormier Plosky will be presenting with Christina Dragon (GMRO, NIH), Amy Ben-Arieh (The Fenway Institute), and Keith Dawson (Genentech) at a plenary session titled “(E01) Fast Forward: Update on Inclusion of Sexual and Gender Minorities in Clinical Research.”
- November 20, 10:30 – 11:45 am PT: Willyanne DeCormier Plosky will moderate a panel titled “(H07) Protecting Third Parties in Research: Whose Job Is it Anyway?” The panel will feature Iris Jenkins (Virginia Tech) and Marilyn Lamm (Clinical Biosafety Services) as speakers.
December 10, 9 – 11 am ET: Biannual Global Meeting of the Joint Task Force for Clinical Trial Competency. This virtual meeting is open to all registrants.
December 12: Meeting of the Bioethics Collaborative.
Publications
August 30: The MRCT Center recently submitted comments to the National Library of Medicine (NLM) in response to the “Evolving the Network of the National Library of Medicine” initiative (NOT-LM-24-001), emphasizing the importance of enhancing health literacy through better access to clinical research information. Key recommendations included expanding MedlinePlus to include more content related to clinical trials, integrating plain language definitions into ClinicalTrials.gov, and providing aggregate study results in plain language for participants. The MRCT Center also suggested improvements to ClinicalTrials.gov that would allow current participants to access updates on study progress and individual results and harmonize study-specific data elements to facilitate cross-study comparisons. These recommendations aim to improve public engagement, transparency, and trust in the clinical research ecosystem.
September 25: The MRCT Center commented on the FDA Draft Guidance on Diversity Action Plans (DAPs) to improve Enrollment of Participants from Underrepresented populations in Clinical Studies (ID FDA-2021-D-0789-0111). The MRCT Center comments point to the need for greater transparency on the timing of FDA feedback and the criteria the FDA uses to assess the community engagement, site selection, recruitment, enrollment, and retention plans in DAPs (both for domestic and global trials). We also recommend clarifying whether DAPs are required for Phase 3 trials for both new and previously approved products, how to operationalize a “do no harm” approach in enrollment goals (that may involve global trial participants), and when it may be appropriate to disaggregate US enrollment goals/data from global enrollment goals/data. The comments suggest a framework similar to the April 2022 draft to improve the final guidance, starting with an epidemiological overview and guiding organizations in developing effective diversity strategies.
MRCT Center Updates
Ava Glazier, a student researcher at the MRCT Center since 2019, was recently promoted to Research Assistant.
Ava is involved in projects focused on Diversity, Inclusion, and Equity in Clinical Research, Cell and Gene Therapy, and Reproductive Health. Previously, she worked on initiatives related to pediatric populations in clinical trials, health literacy, and informed consent forms. In addition to her work at the MRCT Center, Ava has interned at Takeda Pharmaceuticals in the Health Equity Department and at FTI Consulting, where she contributed to efforts to increase patient access in large hospital systems. She is passionate about improving maternal health outcomes in underserved populations and advancing policies to enhance the healthcare experience for patients and providers.
Ava graduated from Brown University with a Bachelor of Arts in Public Health in May 2024. She is pursuing a Master of Public Health focusing on health policy at the Brown University School of Public Health.
The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.
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