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

Actionable Insights: Returning Individual Research Results How do we ethically and effectively return individual research results to participants? The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) "Digging Deeper Webinar Series" tackles this important question through on-demand case studies, providing actionable and practical insights for researchers, sponsors, and stakeholders.    In this series, explore: ✅ Real-world examples of returning research results to participants.  ✅ Challenges and strategies for implementation.  ✅ Best practices that prioritize transparency, respect, and participant engagement.    Whether you’re navigating regulatory landscapes or seeking to build trust through meaningful data sharing, these case studies offer a wealth of knowledge to inform your work.  📚 Access the series and dig deeper: Returning Individual Research Results Webinar Series: https://lnkd.in/eBW7zsXB    #ClinicalResearch #HealthEquity #ParticipantEngagement #DataSharing #ResearchTransparency #MRCTCenter   

Ensuring Access Beyond Trials: A Framework for Continued Care    Post-trial responsibilities are a critical aspect of ethical clinical research, particularly when it comes to continued access to investigational medicines. The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) Center is proud to provide a Framework for Post-Trial Continued Access to Investigational Medicines to guide sponsors, researchers, and stakeholders in navigating these complex responsibilities.    This comprehensive resource complements our foundational Principles on Post-Trial Responsibilities by offering actionable guidance on:    ✅ Identifying and addressing potential barriers to continued access.  ✅ Clarifying roles and responsibilities for stakeholders.  ✅ Developing equitable and sustainable approaches to ensure participant care.    Together, these tools aim to foster trust, transparency, and ethical stewardship in clinical trials, ensuring participants are supported beyond the study’s conclusion.    Explore the framework and join us in advancing participant-centered research: Framework for Post-Trial Continued Access to Investigational Medicines: https://lnkd.in/eCAE6GMz    #ClinicalResearch #EthicalResearch #ParticipantAdvocacy #PostTrialAccess #MRCTCenter   

Empowering Research Participants: Know Your Rights Deciding to participate in a clinical research study is a significant decision—and being informed is key. At the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center), we are committed to ensuring that research participants understand their rights and feel empowered throughout the process.    Our Research Participants’ Bill of Rights highlights the essentials, including:    ✔️ The right to understand all forms and procedures.  ✔️ The right to know the purpose of the study and its potential risks or benefits.  ✔️ The right to ask questions, take your time, and make an informed choice.  ✔️ The right to refuse participation or withdraw at any time.    Explore more resources designed to support participants in making confident, informed decisions about clinical research. Visit our Resources for Research Participants and the Public page for tools, guides, and further information: https://lnkd.in/exAfch2    Together, we advance research with respect and understanding. #ClinicalResearch #HealthLiteracy #ResearchEthics #PatientAdvocacy #Empowerment   

At the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center), our dedication to advancing ethical and effective clinical research is exemplified by our active engagement in public discourse. In 2024, we have submitted 22 public comments addressing critical topics such as:    Revisions to the Declaration of Helsinki: Advocating for enhanced health literacy, informed consent, and participant autonomy.  Federal Evidence Agenda on Disability Equity: Emphasizing the importance of reliable disability data to inform health equity.  Cancer Clinical Trial Eligibility Criteria: Supporting inclusive laboratory value parameters to broaden patient participation.  FDA-NIH Clinical Research Terminology: Suggesting clarifications to enhance understanding among stakeholders.     Our commitment to submitting public comments reflects our mission to uphold the highest standards in clinical research.     View all the MRCT Center’s public comments here: https://lnkd.in/ezrxDrQZ    #MRCTCenter #DoH #DeclarationOfHelsinki #ResearchEthics #HealthPolicy   

🌍 Tomorrow! Join the Global Conversation on Clinical Trial Competency 🌍    The Joint Task Force for Clinical Trial Competency (#JTF), anchored at the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center), continues to set the standards for the global clinical research workforce, ensuring professionals are equipped to conduct trials ethically and effectively.    📅 Upcoming Meeting:  The next biannual JTF meeting is open to the public and will be held virtually on December 10, 9–11 AM ET. These sessions are designed to include global partners and stakeholders.    🔑 Agenda Highlights:  Launch of a participant and patient partner competencies task force  Delphi results from the Data Management Task Force  Proposed team science competencies  Updates on the Portuguese translation of JTF resources  Results from the JTF competency survey conducted in the Philippines  Insights on training community workers using the JTF framework    Don’t miss this opportunity to stay ahead in advancing global clinical trial standards.  👉 Click here to register: https://lnkd.in/exn5nxzy    #ClinicalResearch #ClinicalTrials #JTF #GlobalHealth #CompetencyFramework   

Join the Conversation on Clinical Trial Diversity! On December 9, the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center), in collaboration with the Clinical Trials Transformation Initiative (CTTI) and Milken Institute’s FasterCures—with contributions from the National Academies of Sciences, Engineering, and Medicine—will host a free virtual meeting exploring the current state of diversity in clinical trials. Part of the ongoing Diversity Convergence Project series, this meeting will feature community leaders, policymakers, and researchers as we examine how the post-election policy landscape may shape efforts to enhance clinical trial diversity. 🗓️ Date: December 9, 2024 🕙 Time: 10:00 AM – 1:00 PM ET 💻 Where: Online Don’t miss this opportunity to engage with key stakeholders and contribute to shaping the future of inclusive research. 👉 Register now: https://bit.ly/3P1rUuF #ClinicalTrialDiversity #RepresentationInResearch #MRCTCenter #CTTI #FasterCures

🌟 What’s Up with Long-Term Follow-Up? Ethical, Regulatory, & Operational Challenges 🌟 Join us TOMORROW for an insightful webinar, part of NYU Grossman School of Medicine’s Pediatric Gene Therapy & Medical Ethics (PGTME) Fifth Annual Lunchtime Lecture Series, on long-term follow-up studies (LTFU)—critical to understanding the overall safety profile of gene therapy products. 📅 Date: Thursday, December 5 ⏰ Time: 12:00 – 1:15 PM ET 💻 Location: Virtual Moderator: Carolyn Riley Chapman, PhD MS Riley Chapman, Lead Investigator at the @MRCT Center and Member of the Faculty at @Harvard Medical School Panelists: ·        Najat Bouchkouj, MD, Office of Clinical Evaluation, Office of Therapeutic Products, CBER, FDA ·        Priya Stephen, MD, FAAP, Pediatric Associates of Greater Salem; Wiskott-Aldrich Foundation ·        Aimee Talleur, MD, St. Jude’s Children’s Hospital ·        Himal Thakar, MD, bluebird bio What to Expect: ✅ Gain a deeper understanding of LTFU studies: their purpose, design, and the patient/family experience ✅ Learn about the ethical, regulatory, operational, and social challenges in LTFU studies ✅ Explore actionable ideas to improve the design and conduct of these studies ✅ Hear diverse perspectives from the FDA, industry, non-profit/academia, and a caregiver-pediatrician This public-facing discussion will bring together diverse viewpoints for a candid, accessible dialogue on maximizing the value of LTFU studies while minimizing burdens on participants. 👉 Register here: https://bit.ly/3B9cEZ3 #GeneTherapy #ClinicalResearch #LongTermFollowUp #EthicsInResearch #MRCTCenter  

  🚨 Don’t Miss the Latest from the MRCT Center! 🚨    The November issue of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) Newsletter is here! Packed with updates, resources, and upcoming events, this month’s highlights include:    ✨ New Resources:  Revised Post-Trial Responsibilities Principles and a Framework of Responsibilities to guide ethical and equitable continued access to investigational products. Launch of the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit for advancing inclusive practices in clinical trials. 🎧 Podcast Alert:  Episode 2 of the Trials Beyond Borders podcast is now streaming, featuring insights on enhancing representation in global clinical trials. 🗓️ Upcoming Events, including:  December 9: Virtual Meeting on Clinical Trial Diversity: 2025 and Beyond.  December 10: Global JTF Biannual Meeting on Clinical Trial Competency. 📚 Featured Publications:  Articles on improving diversity in clinical trials and engaging children in pediatric research.    👉 Sign up to receive the newsletter directly to your inbox: https://lnkd.in/eeZx2XeM   #ClinicalResearch #GlobalHealth #DiversityInResearch #MRCTCenter #InnovationInClinicalTrials   

Join Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) for an informative webinar on December 11, from 11 AM ET to 12:30 PM ET to help support clinical trial site personnel in advancing Equitable Access to Clinical Trials. By partnering with the EACT initiative (eactproject.org), hosted by LUNGevity Foundation, we have developed resources and information to reduce financial burdens on patients and families due to their involvement in clinical trials. During this webinar, experts will discuss a variety of key topics relating to financial support for clinical trial participants and review EACT resources and case studies designed to help support trial site personnel.   The webinar is open to anyone, and Registered Nurses who view the webinar are eligible for Nursing Continuing Professional Development (NCPD) credit through the Oncology Nursing Society (ONS).     To register for this webinar, click on this link: https://bit.ly/41cTKLs

📢 Introducing New Resources for Post-Trial Responsibilities: Continued Access The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) Post-Trial Responsibilities Taskforce (PTR Taskforce) is excited to announce the launch of the updated Post-Trial Responsibilities: Continued Access website, featuring two key deliverables:    Revised Post-Trial Responsibilities Principles: A principles-based approach accompanied by an in-depth analysis to guide actions for providing continued access. Framework of Responsibilities: A comprehensive tool for sponsors and researchers to make equitable and fair decisions about continued access to investigational products, supporting policy and guidance development.\    🌍 These resources are designed to support global stakeholders in advancing ethical, equitable practices for post-trial continued access.    👉 Visit the website: https://lnkd.in/e3YABR3d    #PostTrialAccess #PTR #ClinicalTrials #EthicsInResearch #MRCTCenter