The IRB can play an important role in championing the creation of research materials for participants that are clear and understandable. Please join us as we launch a new online Health Literacy training for IRB members and staff. The webinar launch will review health literacy concepts and introduce the online training which is designed to be a self-paced opportunity to learn and apply health literacy principles to the IRB role. The training also offers a facilitation guide to support continued conversations with colleagues about how to implement lessons learned.
Does the IRB play a role in addressing the problem of diversity, inclusion, and equity in clinical research? It is true that the need for change must be systemic and embraced at all levels of the clinical research enterprise, and while IRBs are not the primary driver for assuring diversity, inclusion, and equity in clinical research, IRBs can and should serve as a checkpoint for reviewing research for the principles of DEI. This webinar introduced tools and resources created for IRBs and HRPPs to help drive the change.
Dr. Barbara E. Bierer moderated this webinar, in which MRCT Center Program Manager Dr. Willyanne DeCormier Plosky introduced the background and structure of EbD Metrics Framework and panelists Yasmeen Long (Faster Cures, Milken Institute) and Dr. Rodrigo Garcia (PPD, Thermo Fisher Scientific) discussed their experiences in testing and utilizing it.
The EbD Metrics Framework is a tool developed by the MRCT Center in collaboration with colleagues from professional, trade, academic, regulatory, and patient advocacy organizations. It is designed to advance organizational diversity, equity, and inclusion (DEI) efforts; orient users toward potential entry and follow-up strategies; and provide guidepost measures for assessing and reporting on progress. To access the tool, please visit the EbD Metrics Framework page.
The fourth conference in the series, “Facilitating Pediatric Medicines Development: Models of Global Cooperation,” focuses on global regulatory cooperation with an eye to building on existing models to strengthen the global regulatory ecosystem for pediatric drug approval.
This two-part webinar will take place on 29 November 2022 at 9-11:30am ET and 30 November 2022 at 9-11am ET. We encourage you to attend both parts of this virtual meeting as part two builds on part one.
Developed by: Joint Task Force for Clinical Trial Competency / Mahidol University, SICRES (Siriraj Institute of Clinical Research), NCGM (National Center for Global Health and Medicine)
The participant populations enrolled in clinical trials should reflect the populations of those affected by the disease or condition for which the intervention is being tested. Representation in research is basic, good science. Everyone should be able to “see themselves” in clinical trials and research data and to know whether approved vaccines, therapies, devices, and medications (including medication doses) are right for them Without appropriate representation of the people who will use the tested products, we don’t know how safe or effective those products are for different people (e.g., people with varying ages, sexes, genders, body types, genetic backgrounds, co-existing health conditions, income levels, environmental exposures, and/or life stages).
Despite efforts, there is still a great deal to learn as we work toward greater access to clinical trials and improved health outcomes. The barriers that potential participants face in finding and accessing clinical trials differ, as do the approaches that might mitigate these challenges. For some people, reducing the burden of participation through the introduction of decentralized elements is helpful; for others, it is translation, communication (e.g., plain language, visualization), reimbursement, community, and caregiver involvement, among others. And, while the MRCT Center released guidance and tools to address representation in research early in the COVID pandemic, we continue to learn more about the specific ways that people from different populations can best be supported to participate in clinical research.
Our work continues, and we remain committed to it. We are continually expanding our portfolio of tools and resources. Our aim is for everyone to have a “fair shot,” both in terms of the opportunity to participate in clinical trials and in terms of being able to trust the results of that research, conducted through rigorous and ethical research practices.
Describe the obstacles potential participants are facing in accessing U.S. and multi-regional clinical trials, including scientific, ethical, and geographical challenges; and generate and share lessons learned about potential approaches for effective communication, recruitment, and retention of participants from a variety of backgrounds.
Support engagements and sustainable partnerships with community champions, organizations, and referring providers, and workforce development of clinical research personnel. Develop and disseminate actionable and scalable solutions (“tools”) to support representation in research, greater access to clinical trials, and improved health outcomes.
April 2021 – July 2021: Leaning In webinar series “Driving Inclusion in Clinical Research” emphasizes how to plan for inclusion, implement recommendations, and sustain progress.
The MRCT Center is guided by the fundamental belief that communicators are responsible for sharing information in ways that are designed to promote audience understanding and empowerment. Clear research communications that are understandable to patient and participant communities are critical to inclusive, representative research studies.
As such, the MRCT Center launched an effort in 2018 to develop clinical research-focused health literacy resources with a workgroup of diverse representatives from across the research ecosystem that would support the integration of health literacy strategies across the clinical development life cycle. The resulting Health Literacy in Clinical Research website launched in October 2019.
All of us here at the MRCT Center strive to develop tools and resources that promote understanding, especially when the audience includes patients, participants, and caregivers. Our plain language, patient-centric Clinical Research Glossary, which was piloted in 2020, continues to grow via a collaborative consensus-building workgroup process, and was adopted as a CDISC global standard in April 2023.
The most recent version of the Clinical Research Glossary includes 187 words and definitions, customized images, and additional details and resources that provide users with valuable background information. Thirty new terms and definitions will be released in September 2025.
Other Health Literacy in Clinical Research efforts include the 2025 release of a suite of Data Literacy Infographics, an ongoing virtual Health Literacy Training and Checklist for IRBs, and a newly initiated project to update the Health Literacy in Clinical Research website content.
Objectives
Establish and support initiatives that increase the use of health literacy best practices when developing clinical research-related communications for patients, participants and their caregivers.
Develop and share resources with sponsors and funders, investigators and their study teams, and institutional review boards that maximize their efforts to integrate health literacy principles throughout the clinical trial life cycle from recruitment and informed consent through close-out and return of results.
Promote the use of plain language in clinical research via a harmonized, patient co-developed Clinical Research Glossary that can be used across the research industry, and used by research professionals and potential participants to foster clear, bi-directional information exchange.
