Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center)

?????New Episode Alert: Trials Beyond Borders Podcast????? ? Episode 2 is now live on all streaming platforms! This episode features an insightful conversation with?Racquel Bruton, MBA, Associate Director and Clinical Trials Diversity Portfolio Lead at Biogen, and?Willyanne DeCormier Plosky, Program Director at the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center).? ? Together, they dive into how sponsor companies are advancing?representation in clinical trials, with a particular focus on populations outside the U.S. Racquel shares Biogen's?longstanding commitment to reaching underrepresented populations?and discusses how the MRCT Center’s roadmap can guide organizations in developing and executing impactful diversity action plans.? ? Whether you're looking to enhance your organization’s diversity strategies or want practical insights on operationalizing these efforts, this episode is a must-listen!? ? ???Tune in now and join the conversation:?https://lnkd.in/eGqyzGDY? ? #ClinicalTrials #DiversityInResearch #GlobalHealth #MRCTCenter #Biogen #RepresentationInResearch? ?

?? Join us for an insightful webinar on Long-Term Follow-Up in Gene Therapy!? ? Carolyn Riley Chapman, PhD MS, MRCT Center Member of the Faculty and Lead Investigator, will moderate and co-sponsor “What’s Up with Long-Term Follow-Up: Ethical, Regulatory, and Operational Challenges” in collaboration with the Pediatric Gene Therapy and Medical Ethics (PGTME) Working Group at the Division of Medical Ethics, NYU Grossman School of Medicine.? ? Part of PGTME’s fifth annual Lunchtime Lecture Series, this session will delve into:? ? ?? Why and how Long-Term Follow-Up (LTFU) studies are conducted for gene therapies? ?? Ethical, regulatory, and operational challenges of LTFU studies? ?? Strategies to maximize value while minimizing the burden of LTFU? ? ??? Don’t miss this opportunity to gain actionable insights into one of the most critical areas in gene therapy research.? ? ?? Register here: https://bit.ly/3B9cEZ3 ? #GeneTherapy #MedicalEthics #ClinicalResearch #LongTermFollowUp #LTFU #MRCTCenter #EthicsInResearch?

? ?? Introducing the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit! ?? This newly updated, comprehensive resource includes seven tools designed to advance equity and inclusion in clinical research. Whether you're assessing site readiness, designing inclusive participant questionnaires, or gathering feedback through exit surveys, these tools provide actionable steps to ensure your research represents the diversity of the communities it serves.? ? For the first time, all seven tools—including three new additions—are available in one easy-to-use compendium. Let's drive meaningful representation and create clinical trials that reflect and respect every individual.? ? ?? Explore the full toolkit here: LGBTQIA+ Inclusion Toolkit- https://bit.ly/41459NQ? ? #LGBTQIAInclusion #ClinicalResearch #HealthEquity #InclusiveResearch #DEI #RepresentationMatters #MRCTCenter?

?? Join us for the next Joint Task Force for Clinical Trial Competency (JTF) meeting!? ? The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) biannual JTF meetings are an open forum to advance clinical research workforce standards, fostering skills and knowledge that drive global impact. These virtual gatherings bring together diverse voices from across the world, and the public is warmly invited to participate.? ? ?? Date: December 10? ?? Time: 9 - 11 AM ET? ?? Location: Virtual? ? This meeting's highlights include:? Launch of a new task force focused on participant and patient partner competencies? Delphi results from the data management task force? Proposed team science competencies?? Insights from implementing the Portuguese translation of the framework? Results from the JTF competency survey in the Philippines? Training community workers using the JTF framework? ? Don't miss this opportunity to contribute to the future of clinical trial competency!? ? ?? Click here to register: https://bit.ly/3N5LhBs

The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) Center is excited to share the release of an introductory video for the ICH E8(R1) Guideline – General Considerations for Clinical Studies. This video, now available on the International Council for Harmonisation (ICH) website, provides an overview of essential principles in clinical research, with a focus on quality by design.? ? Developed by the MRCT Center, this resource is designed to help researchers, sponsors, and stakeholders better understand the framework and goals of the ICH E8(R1) guideline. Stay tuned as we continue building on this foundation with a series of in-depth training modules coming soon.? ? Watch the video here: https://lnkd.in/eazxU5yh? ? #ClinicalResearch #ICHE8R1 #QualityByDesign #MRCTCenter #ICHGuidelines?

Barbara Bierer, Sylvia Baedorf Kassis, MPH, CYT, and Alyssa Panton from the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center), together with Devaki T. Thavarajah and Trishna Bharadia, BA(hons), MFPM(Hon), MFPM(Hon), have co-authored an insightful article, “Creating Educational Materials About Clinical Research Data for Patients and the Public: A Multifaceted Journey in the Current Digital Age,” published in Medical Writing.? ? This article builds on the MRCT Center’s ongoing commitment to advancing health and data literacy. It explores how educational resources—such as videos and infographics—can make clinical research data more accessible, addressing public concerns around data privacy, transparency, and ethical information sharing. In an age where misinformation can create barriers to understanding, these tools aim to rebuild trust and ensure that patients and the public have access to clear, understandable information.? ? https://bit.ly/48CkYwE ? #DataLiteracy #HealthLiteracy #ClinicalResearch #MRCTCenter #PatientEngagement??

We're excited to share a new Health Affairs article calling for a coordinated, national strategy to address longstanding gaps in the representation of underrepresented populations within U.S. clinical trials. Read the full article here: https://bit.ly/3UGqlWd Despite facing disproportionately high rates of serious health conditions, Black, Latino, Native American, Asian, and rural communities remain significantly underrepresented in clinical research. This gap not only limits scientific understanding but also restricts access to critical healthcare advancements. To close this representation gap, the Diversity Convergence Project - a collaborative effort led by Clinical Trials Transformation Initiative (CTTI), Milken Institute's FasterCures, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center), and with?contributions from the NASEM Health and Medicine Division (National Academies of Sciences, Engineering, and Medicine) – aim to close this gap by advocating for a national, cross-sector approach to improving representation in clinical trials. The project builds on the publication Toward a National Action Plan for Achieving Diversity in Clinical Trials, which outlines actionable steps across eight key areas to create a more inclusive clinical trials system. Creating lasting change requires collaboration among academia, industry, government, patient advocacy groups, and communities. Together, we can build a system where all populations have equal opportunities to contribute to and benefit from scientific advancements. Join us in making this vision a reality.

Hayat Reshid Ahmed, Program Manager at the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center), recently joined a Clinical Trial Diversity Roundtable hosted by Congresswoman Robin Kelly (IL), Chairwoman of the Congressional Black Caucus (CBC) Health Braintrust, on October 8 at La Rabida Children’s Hospital in Chicago. Congresswoman Kelly convened healthcare and research stakeholders to discuss efforts to diversify clinical trials and address the historical mistrust within the Black community, rooted in past unethical research practices.? ? The roundtable explored strategies to rebuild trust through community education and workforce diversification in the scientific and medical fields. Congresswoman Kelly heard insights from representatives of leading organizations, including the MRCT Center, Cancer Support Community, Patient-Centered Outcomes Research Institute, Genentech, Howard Brown Health-Sheridan, Bristol Myers Squibb, Walgreens Boots Alliance, City of Hope Chicago, and ATW Health Solutions. Key government partners, including the Illinois Department of Public Health, the Department of Health and Human Services, and the NIH, were also present, underscoring a united commitment to tackling these critical issues.? ? To read the MRCT Center’s remarks presented at the event, click here: https://lnkd.in/eum8wRPx? ? #ClinicalTrialDiversity #MRCTCenter #HealthEquity #CommunityTrust??

The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) Center, in collaboration with the World Health Organization (WHO), is pleased to announce the launch of Ethics and Review of Interventional Clinical Research Training, now available free of charge worldwide.? ? This course was developed to address the growing need for training on the scientific and ethical dimensions of interventional clinical trials. Tailored for research ethics committee members, chairs, administrative staff, and protocol reviewers, it also benefits regulators, investigators, study staff, and care providers involved in clinical trials.? ? Enroll today to enhance your understanding of ethical considerations in clinical research and ensure best practices in trial review.? ? https://lnkd.in/eUM4vieN? ? #ClinicalResearch #ResearchEthics #MRCTCenter #WHO #GlobalHealth? ? ?

Barbara Bierer, Faculty Director of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center), has authored a viewpoint article, “Declaration of Helsinki – Revisions for the 21st Century,” published in JAMA. The article explores the significant updates in the 2024 revision of the Declaration of Helsinki, now marking its 60th anniversary.? ? The article highlights key changes, including the expansion of ethical responsibilities to all researchers, the shift from referring to “subjects” to “participants” to underscore autonomy, and the critical importance of obtaining “free and informed consent.” The article also delves into complex ethical considerations such as vulnerability, inclusivity, post-trial access, and the use of data for research—particularly in the context of multi-national clinical trials. https://bit.ly/3CetUfR #EthicsInResearch #DeclarationOfHelsinki #ClinicalResearch #MRCTCenter?