In the Spotlight
LGBTQIA+ Resources
The need for participant diversity in clinical trials is well-recognized, but the inclusion of LGBTQIA+ individuals has often been overlooked. The MRCT Center established a working group comprised of experts from medical and research institutions, pharmaceutical companies, CROs, clinics, advocacy groups, and LGBTQIA+ community members to improve engagement and participation. The working group aims to advance a more comprehensive integration of inclusivity in clinical research, particularly addressing the historical underrepresentation of LGBTQIA+ individuals.
The MRCT Center has developed two practical guides – the LGBTQIA+ Inclusive Imagery Case Study and an LGBTQIA+ Inclusive Language Checklist – to assist researchers in effectively including LGBTQIA+ individuals in clinical trials to ensure that study populations are truly representative.
Additional tools will be released throughout the year, and they will address data collection, privacy, and accountability. These are part of a comprehensive effort to ensure that all potential participants, including the LGBTQIA+ community, see themselves reflected in clinical trial research and outcomes.
Please contact us here if you would like additional information or periodic updates about this work.
Toward a Framework to Improve Diversity and Inclusion in Clinical Trials
Racial and ethnic minorities comprise a significant portion of the U.S. population, yet their representation in clinical trials remains disproportionately low. Addressing this disparity is crucial for equitable healthcare outcomes.
The Diversity Convergence Project has convened several meetings over the last year to explore opportunities to improve racial and ethnic diversity in clinical trials, focusing on system-level change and collective efforts across organizations and sectors. The Clinical Trials Transformation Initiative (CTTI) hosted the first meeting in June 2023, the MRCT Center the second meeting in September 2023, and FasterCures and the Milken Institute the third meeting in November 2023.
The National Academies of Sciences, Engineering, and Medicine Forum on Drug Discovery, Development, and Translation and the National Cancer Policy Forum will host the fourth hybrid public workshop meeting on May 20 (Clinical Trials Day). This workshop will consider strategies for equitable participation and innovative trial design to support community investment, engagement, and workforce development. Based on input from the first three meetings, survey results, and analyses of existing research, a National Action Plan for Achieving Diversity in Clinical Trials will be released in advance of the May 20 workshop to facilitate collective action toward a framework for implementation.
Click here to register for the May 20 hybrid public workshop.
Action and Influence: Implementing the Clinical Research Glossary and Your Critical Role in Public Review
How are people and organizations using the updated Clinical Research Glossary? Join us for an insightful webinar on Tuesday, June 4, from 11 – 12 PM ET to explore the practical uses and applications of the MRCT Center’s Clinical Research Glossary. Learn how this glossary can enhance the participant’s clinical research experience and how you can help shape the future of this resource, recognized as a CDISC global standard.
Topics:
- The Importance of Plain Language: Exploring how clear communication resources enhance understanding and trust-building.
- Real-World Applications: Discussing case studies where the glossary has been implemented.
- Public Participation in Public Review: Inviting feedback on proposed and existing glossary terms throughout the annual review cycle.
Click here to register.
For more about the MRCT Center’s Clinical Research Glossary, including common questions, how to cite the MRCT Center when using glossary resources in your materials, and resources, including slides and the recording from a recent webinar, click here.
Joint Task Force for Clinical Trial Competency: Events and Updates
JTF Framework: Now available in Arabic
The Arabic translation of the JTF Framework has been released. Click here to view.
The JTF Framework is now available in 11 languages: English, Spanish, Japanese, French, Thai, Bahasa Indonesia, Italian, Vietnamese, Chinese, Korean and Arabic. Click here for links to the complete list of translations.
Joint Task Force for Clinical Trial Competency (JTF) Global Meeting: June 6
Please join us on Thursday, June 6, from 9 – 11:00 AM ET for the virtual biannual global Joint Task Force for Clinical Trial Competency (JTF) meeting to learn about updates and coordinate ongoing activities. We will hear about Cantrain, a comprehensive training program in Canada based in part on the JTF Framework, and other updates. This meeting is open to the public.
Click here to register.
Events & Presentations
April 2: The MRCT Center held a webinar to announce the release of the new, expanded Clinical Research Glossary. With over 160 definitions, including images and supportive information, the Clinical Research Glossary has been designed to support the communication of clear research information, along with tailored, shareable images to foster engagement and understanding. It is now a CDISC standard.
April 4-5: Barbara Bierer gave the keynote presentation “Decentralized Clinical Trials – An Evolving Landscape” at the Decentralized Clinical Trial’s two-day in-person workshop hosted by the Society of Clinical Research Associates (SOCRA) in Savannah, GA. She also gave a presentation on “Ethics Review of Decentralized Clinical Trials.”
April 9: Willyanne DeCormier Plosky participated in two panels at the Society for Clinical Research Sites (SCRS) IncluDE Summit: a plenary session on “Equity at the Crossroads: Financial Barriers in Clinical Research” and a breakout session entitled “Inclusivity Forum: People with Disabilities.”
May 1: Barbara Bierer will present at Health Resources in Action (HRA)’s “Promoting Diversity in Clinical Trials” webinar, addressing the levers funders can use to advance representation in clinical trials and examples of guidance that funders can provide applicants.
May 3, 1:30-4 PM ET: Meeting of the Research, Regulatory, and Development Roundtable (R3). Topic: Real World Evidence (RWE) and Emerging Trends in Clinical Trial Subject Recruitment. Open to sponsors of the Research, Regulatory, and Development Roundtable (R3).
May 8: Carolyn Chapman will present a poster, “Delivering on the Ethics of Gene Therapy Trials,” at the ASGCT Annual Meeting in Baltimore.
May 7-10: Barbara Bierer and Sarah White will attend the AVAREF Technical Committee and Steering Committee meetings in Harare, Zimbabwe. They will present a summary of the work in Africa in which the MRCT Center has participated and discuss progress on training assets in development.
May 13: Barbara Bierer and Sarah White will engage bioethicists and ethics committee members in a robust discussion of challenges in Butaro, Rwanda.
June 14, 12:30 – 3 PM ET: Meeting of the Bioethics Collaborative (BC). Topic: Reciprocity in Research: What do we owe host communities? Open to sponsors of the Bioethics Collaborative.
Publications
March 30: The MRCT Center submitted a public response to the French National Institute of Health and Medical Research (“INSERM”)’s draft ethics charter aimed at the protection of healthy volunteers in clinical trials. The draft ethics charter consisted of 17 proposed articles; the MRCT Center offered both a general commentary on the entire charter and provided feedback and/or recommended new language on 14 of the 17 articles. While the MRCT Center’s comments reflected our support for the broader endeavor, a number of suggestions were made to more clearly define the intent and reach of the charter.
April 15: The MRCT Center submitted public comments to the FDA draft guidance on data monitoring committees in clinical trials (Docket #FDA-2001-D-0219).
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