Comments provided to: U.S. Food and Drug Administration
Description: The MRCT Center comments point to the need for greater transparency on the timing of FDA feedback and the criteria the FDA is using to assess the community engagement, site selection, recruitment, enrollment, and retentions plans in DAPs (both for domestic and for 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. To improve the final guidance, the comments suggest a framework similar to the April 2022 draft, starting with an epidemiological overview and guiding organizations in developing effective diversity strategies.
Comments provided to: National Institutes of Health
Abstract: 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.
The first podcast in our new series, “Trials Beyond Borders: Building Representative Clinical Trials Worldwide.” The podcast features a conversation with MRCT Center Program Director Willyanne DeCormier Plosky and Tinaya Gray, a consultant with ICON plc, focusing on communications between sponsors, CROs, and sites in planning for diversity action plans in the context of global trials.
Description: On Thursday, September 19, 2024, the MRCT Center and Ropes & Gray will be co-presenting a webinar to review significant changes to the federal research misconduct regulations outlined in the highly anticipated Final Rule, issued on September 12, 2024, by the U.S. Department of Health and Human Services’ (“HHS”) Office of Research Integrity (“ORI”). Ropes & Gray has prepared a redline of the changes against the current regulations (available here) and a redline of the changes against the proposed rule (available here).
The Final Rule outlines changes to the federal research misconduct regulations set forth at 42 C.F.R. Part 93 (“Part 93”). Part 93 sets forth the federal regulatory framework that must be followed for investigating allegations of research misconduct (falsification, fabrication, or plagiarism) pertaining to research in which U.S. Public Health Service funds—including NIH funds—have been provided. The changes outlined under the Final Rule are extensive and highly impactful and include significant changes from the proposed rule that was published by ORI in October 2023. By way of example, the Final Rule omits a provision in the proposed rule that would have prohibited institutions from reaching an “honest error” finding at an early stage of a research misconduct proceeding. These changes will require institutions to implement significant changes to their existing policies and practices for reviewing allegations of misconduct. The Final Rule provides that institutions must implement these changes by January 1, 2026.
For a detailed discussion of the key changes in the Final Rule, we invite you to attend our webinar on Thursday, September 19, 2024. MRCT Center Faculty Director Barbara Bierer and Ropes & Gray presenters, including Mark Barnes, co-founder and Faculty co-Director of the MRCT Center, will be joined by The University of Texas MD Anderson Cancer Center’s Madhu Purewal, Senior Legal Officer & Executive Director, Research Compliance, who will offer perspective during the question and answer portion of the webinar on the significance of the rule changes from the perspective of a large academic research institution.
November 14, 2024
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November 15, 2024
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JOIN US! MRCT Center 2024 Annual Symposium
The MRCT Center is proud to invite clinical research stakeholders—including professionals, patient participants, and advocates—to the 2024 Annual Symposium, a complimentary event celebrating 15 years of advancing ethical, actionable, and practical solutions for clinical trials. This symposium will bring together diverse voices to explore cutting-edge advancements, regulatory updates, and participant-centered approaches shaping the future of clinical research.
Event Details:
Date: November 14–15, 2024
Location: Gordon Hall & Countway Library, Harvard Medical School, Boston, MA. A virtual option is also available.
Cost: Free to all registrants
Featured Keynote:
We are honored to welcome Dr. Khair ElZarrad, Director, Office of Medical Policy, FDA, as our keynote speaker. Dr. ElZarrad will share perspectives on current trends and future developments in clinical research and regulation.
Highlighted Panels:
Panel 1: Post-trial, Continued Access to Investigational Medicines and Devices
This panel will address the complexities of ensuring post-trial access to investigational interventions, spotlighting practical solutions and ongoing challenges.
Panel 2: Expanding the Uses of Data and AI in Support of Clinical Trials
Explore how AI-driven digital twins are transforming the landscape of clinical trials by creating virtual simulations of patient outcomes. This session will cover the technical, ethical, and practical considerations of this game-changing technology.
Panel 3, Breakout 2: A Conversation with Participant Advocates: The Future of Participant-Centered Clinical Research
Participant/advocates will share their personal experiences and discuss how participant-centered clinical research can better address participant needs.
Panel 4: Accessibility in Decentralized Trials
This panel will focus on the importance of inclusive trial design, emphasizing how decentralized trial components can be made accessible to all participants, particularly those with disabilities, through universal design principles.
Additional Highlights:
Networking opportunities, including lunch and a cocktail reception
Vivli/MRCT Center Annual Meeting on Friday, November 15: Symposium registrants are invited to join the Annual Meeting at the Harvard Faculty Club, which will include:
Keynote by Steffen Thirstrup, CMO, European Medicines Agency, on the future of data sharing and the European Health Data Space
Panel Discussions on data sharing, Health Information Exchanges (HIE), and the opportunities and risks of AI in clinical research
Help advance solutions that lead to meaningful change in clinical trials and ultimately improve patient outcomes. Join us in Boston to help foster collaboration and drive the implementation of strategies that deliver tangible results for both patients and the wider research community.
The Model Diversity Action Plan (DAP) was developed in response to the FDA’s latest directive aimed at improving diversity within clinical trial participation. Built upon the MRCT Center’s Recruitment Strategy Document, this framework supports compliance with FDA standards. The Model DAP also outlines clear objectives that extend beyond the FDA’s initial guidelines, emphasizing a broader international viewpoint. Sponsors are encouraged to delineate specific regions and countries targeted for trial inclusion, detailing proactive strategies designed to overcome obstacles related to diverse, inclusive, and equitable recruitment practices, particularly outside the United States. While these additional details may not always be mandatory for FDA submissions, they are pivotal in fostering a comprehensive approach to trial design and execution. Moreover, the Model DAP expands on the FDA’s suggested five sections within their draft guidance, ensuring alignment with regulatory expectations while advancing global standards in clinical research diversity and inclusion. This dynamic document will evolve as the FDA guidance is finalized.
The Global Representation Roadmap provides a structured approach for stakeholders to define and implement DEI strategies across their global clinical research portfolios. It guides organizations through a seven-stage process tailored to account for varying dimensions of DEI across different countries and contexts. Key focuses include clarifying organizational DEI objectives, defining epidemiology by therapeutic area in target countries, and considering ethical implications in site selection. The Global Representation roadmap prompts stakeholders to address country-specific regulatory requirements related to diversity and outlines minimum actions in their absence. It advocates for proactive DEI targets and capacity-building initiatives, while emphasizing ongoing community engagement and accountability through periodic ethics checkpoints. Additionally, it encourages the use of program-specific Diversity Action Plans to enhance recruitment effectiveness and ensure continuous improvement and transparency in Global Representation efforts.
To celebrate Health Literacy Month, the MRCT Center presented three engaging and informative webinars to provide practical tools for incorporating health literacy and accessibility best practices into communicating participant-facing clinical research information.
The Research Ethics Action Collaborative for HRPPs (REACH) is an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham to curate, align, and disseminate tools to advance access to and inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community.
Description: Join the REACH collaborative for a dynamic webinar focused on improving PowerPoint presentations through clear, accessible, and inclusive considerations. This session will begin by continuing the discussion from the first two October 2024 MRCT Center webinars on developing impactful and empowering participant-facing materials (such as Informed Consent forms) and utilizing plain language. We will show, through examples from the Accessibility by Design in Clinical Research Toolkit, how these health literacy principles congruently apply from a disability perspective. Because so much communication is now virtual, we’ll then move to exploring how to make PowerPoint content not only readable and approachable, but also formatted for accessibility and inclusiveness of people with disabilities. Whether you’re a researcher, HRPP, or involved in other areas of clinical research, this webinar will provide valuable insights into creating presentations that are both accessible and engaging.
Key Topics:
Learn about the core concepts of health literacy and why they matter in clinical research. Understand how these principles can improve the clarity of your presentations.
Explore hands-on approaches for integrating readability and health literacy principles into your PowerPoint slides.
Participate in a moderated discussion and Q&A session to delve deeper into the application of plain language and readability in presentations. Share your experiences and get answers to your questions.
To celebrate Health Literacy Month this October, the MRCT Center invites you to participate in three engaging and informative webinars. 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.
Description: Join the MRCT Center for this webinar that will feature experts from the Dana Farber Cancer Institute who will share their experience in developing a patient advocacy-driven return of results process for making Plain Language Summaries available to participants in breast cancer-related studies.
The moderator, Sylvia Baedorf Kassis, will join the panelists, Paula Steeves, Lead Patient Advocate, Breast Oncology, Dana-Farber Cancer Institute, and Timothy Erick, Science Writer, Dana-Farber Cancer Institute.
Please join us as we discuss:
The core elements of creating and disseminating Plain Language Summaries.
What results to return, who to involve in the creation process, and how to approach dissemination.
How to start returning results with your study participants. Share your experiences and get answers to your questions in a moderated discussion and Q&A session.
To celebrate Health Literacy Month this October, the MRCT Center invites you to participate in three engaging and informative webinars. 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.
Description: This informative webinar will leverage experience from the Office of Human Research Protections, the All of Us Research Program, and the MRCT Center to highlight resources and approaches for communicating informed consent information in innovative, participant-centered ways that support empowered decision-making.
The moderator, Sylvia Baedorf Kassis, will join the panelists, Marianna Azar of the Office for Human Research Protections and Katherine Blizinsky from the All of Us Research Program.
Implementing a participant-centric approach, utilizing the Clinical Research Glossary, and integrating innovative elements into the consent process.
Participate in a moderated discussion and Q&A session to delve deeper into ways to enhance the informed consent process. Share your experiences and get answers to your questions.
We look forward to sharing this important work with you.
