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X-WR-CALNAME:The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
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X-WR-CALDESC:Events for The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
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DTSTART:20260308T070000
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DTSTART;TZID=America/New_York:20260903T120000
DTEND;TZID=America/New_York:20260903T150000
DTSTAMP:20260812T093510
CREATED:20251125T173032Z
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SUMMARY:Operation TrialBlazer
DESCRIPTION:The Research\, Development\, and Regulatory Roundtable (R3) is a forum to discuss pre-competitive issues in drug and device development\, regulatory oversight of clinical trials\, and human subjects research. Meetings convene policymakers\, legal counsel\, academicians\, industry representatives\, and global regulators. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP. \n\n\n\nThis hybrid meeting is open to sponsors of the Research\, Development\, and Regulatory Roundtable. \n\n\n\nTopic: Operation Trialblazer \n\n\n\nAbstract: On June 22\, 2026\, the U.S. Department of Health and Human Services (HHS) announced “Operation TrialBlazer”\, a coordinated\, department-wide initiative to restore U.S. leadership in clinical research and development (the “Initiative”). The Initiative spans multiple HHS divisions: the Food and Drug Administration (FDA)\, the National Institutes of Health (NIH) (including the National Center for Advancing Translational Sciences (NCATS) and the National Cancer Institute (NCI))\, the Advanced Research Projects Agency for Health (ARPA-H)\, the Office of the National Coordinator for Health Information Technology (ONC)\, and the HHS Office of Inspector General (OIG). \n\n\n\nIn this meeting of the R3\, we will explore the policy underpinnings of the Initiative along with its most salient features\, include the following: \n\n\n\n\n1.  Motivations for the Initiative\, including geopolitical and competitive concerns with the expansion of clinical trials in China and other ex-U.S. geographies\n\n\n\n2.  HHS OIG’s request for information on Anti-Kickback Statute and Beneficiary Inducements CMP Exceptions for clinical trial participant remuneration\n\n\n\n3.  Cross-agency collaboration on clinical trial participant-facing financial barriers\n\n\n\n4.  Single IRB reform\n\n\n\n5.  Electronic health record-based clinical trial recruitment\n\n\n\n6.  FDA’s proposed expedited IND pilot program\n\n\n\n7.  FDA’s revised draft guidances on substantial evidence of effectiveness and master protocols\n\n\n\n\nFor more information\, please email at MRCT@BWH.HARVARD.EDU \n\n\n\n\n\n\n\n\n\n\n\nDeliverables\n\n\n\n\n\n\nProjects\n\n\n\n\n\n\n\n			    October 18\, 2022 \n    Promoting Global Clinical Research in Children ›
URL:https://mrctcenter.org/tribe-events/meeting-of-the-research-development-and-regulatory-roundtable-r3-10/
LOCATION:hybrid
CATEGORIES:Meetings
ATTACH;FMTTYPE=image/jpeg:https://mrctcenter.org/wp-content/uploads/2022/11/R3.jpg
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20260908T100000
DTEND;TZID=America/New_York:20260908T123000
DTSTAMP:20260812T093510
CREATED:20251002T185425Z
LAST-MODIFIED:20260722T155308Z
UID:24837-1788861600-1788870600@mrctcenter.org
SUMMARY:What’s Mine Is Mine and What’s Yours Is Mine: Data Ownership and Sovereignty 
DESCRIPTION:Topic: What’s Mine Is Mine and What’s Yours Is Mine: Data Ownership and Sovereignty \n\n\n\nAbstract: As big data and AI become more widespread\, concerns about data privacy and security have intensified\, with many countries restricting access to their citizens’ data (and\, in some settings\, to data stored in those countries\, regardless of citizenship). International ethical guidelines\, such as the Declaration of Taipei\, state that individuals are entitled to control the use of their personal data. But most people fail to appreciate how much of their data is already publicly available\, how much of their data they can no longer control\, and how extensive their digital footprint is. When they do learn\, individuals feel excluded from decisions about their information and express the desire to determine how their data is accessed and used. Are data ownership\, consent\, and permissions to control one’s existing data still realistic? Are there other ways to demonstrate respect when obtaining consent is not possible? Are there data governance models that can provide oversight for participant concerns or wishes?  What actions\, beyond consent\, should be taken to respect or benefit the participants who contributed their data? \n\n\n\nThis meeting is open to sponsors of the MRCT Center Bioethics Collaborative and select invited guests. For more information about the Bioethics Collaborative and how to become a sponsor\, click here.
URL:https://mrctcenter.org/tribe-events/whats-mine-is-mine-and-whats-yours-is-mine-data-ownership-and-sovereignty/
ATTACH;FMTTYPE=image/jpeg:https://mrctcenter.org/wp-content/uploads/2022/11/Bioethics2.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20260922T100000
DTEND;TZID=America/New_York:20260922T110000
DTSTAMP:20260812T093510
CREATED:20260706T180719Z
LAST-MODIFIED:20260729T170956Z
UID:26034-1790071200-1790074800@mrctcenter.org
SUMMARY:Childhood Cancer Academic-Industry Collaborative Platform Trials (C3PT): Toolkit Launch Webinar
DESCRIPTION:This webinar will explore key challenges\, opportunities\, and best practices for successful partnerships between academia and the pharmaceutical industry to design and deliver platform trials for children and adolescents with cancer. \n\n\n\nThe MRCT Center\, in partnership with ITCC (Innovative Therapies for Children and Adolescents with Cancer)\, Blood Cancer United\, and the Children’s Oncology Group\, will release a framework for those planning and delivering platform trials for pediatric oncology\, including a position narrative and the Childhood Cancer Academic-Industry Collaborative Platform Trials (C3PT) Toolkit\, a range of tools to help users put the framework into practice. \n\n\n\nThe C3PT toolkit builds on the outputs of the “Advancing Pediatric Platform Trials: Streamlining Development\, Maximizing Impact” workshop and a follow-up Pediatric Oncology Workshop in July 2025\, both multi-organizational\, collaborative efforts. \n\n\n\nThe webinar will include opening remarks to set the scene\, a moderated multi-stakeholder discussion\, and time for audience Q&A. \n\n\n\n    \n    Register Now\n    \n\n\n\n\n\n\nDeliverables\n\n\n\n\n\n\nProjects\n\n\n\n\n\n\n\n			    October 18\, 2022 \n    Promoting Global Clinical Research in Children ›
URL:https://mrctcenter.org/tribe-events/childhood-cancer-academic-industry-collaborative-platform-trials-c3pt-toolkit-launch-webinar/
LOCATION:Virtual Event
CATEGORIES:Presentations / Webinars
ATTACH;FMTTYPE=image/png:https://mrctcenter.org/wp-content/uploads/2026/07/PEDs_C3PT_09-2026_Webinar_Graphic_1a_06-29-2026_REGISTER-NOW.png
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20260924T120000
DTEND;TZID=America/New_York:20260924T130000
DTSTAMP:20260812T093510
CREATED:20260302T153443Z
LAST-MODIFIED:20260706T165923Z
UID:25495-1790251200-1790254800@mrctcenter.org
SUMMARY:Investigator Oversight in Decentralized Trials: New Resources and Practical Tools
DESCRIPTION:  \n\n\n\nWebinar\n\n\n\n\n\n\n\n\n\n\n\nThe Investigator Oversight in Decentralized Trials project builds on the MRCT Center and Medable’s prior IRB/EC Considerations for DCT Review. As data capture and trial activities increasingly occur outside traditional trial sites\, the characteristics of decentralized trial conduct have created uncertainty about Investigator oversight and how it should be structured when the PI has no supervisory or contractual role with others collecting data and conducting trial activities. \n\n\n\nTo help close that gap\, the MRCT Center and Medable developed four new resources for investigator oversight in clinical trials with decentralized elements (DCTs)\, with input from the Investigator Oversight in DCT task force. These resources include a proportional oversight framework\, an approach to optimize DCT elements\, a model instruction sheet for local healthcare providers\, and a set of illustrative scenarios covering roles and responsibilities in common clinical situations from withdrawal requests to serious adverse events. \n\n\n\nOn Thursday\, September 24\, 2026\, from 12:00 PM – 1:00 PM ET\, the MRCT Center and Medable will host a webinar to release the resources and walk through their intended use and how they fit together. \n\n\n\n    \n    Click here to register\n    \n\n\n\n\n\n\n\n\n\n\nRelated: IRB/EC Considerations for DCT Review\n\n\n\n\nIRB/EC Considerations for DCT Review\n\n\n\n\n\n\n\n\nRelated: On-demand webinar\n\n\n\n\nEthical Considerations for Decentralized Clinical Trials: Tools\, Resources and Best Practices\n\n\n\n\n\n\n\n\n\n\n\n\n\n			    October 18\, 2022 \n    Promoting Global Clinical Research in Children ›
URL:https://mrctcenter.org/tribe-events/investigator-oversight-in-decentralized-trials-new-resources-and-practical-tools-2/
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://mrctcenter.org/wp-content/uploads/2026/03/DCT-PI_09-2025-Webinar_1200x627px_REGISTER-NOW.png
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20261021T080000
DTEND;TZID=America/New_York:20261022T140000
DTSTAMP:20260812T093510
CREATED:20260701T152610Z
LAST-MODIFIED:20260701T152613Z
UID:26006-1792569600-1792677600@mrctcenter.org
SUMMARY:MRCT Center 2026 Annual Symposium
DESCRIPTION:Meeting\n\n\n\n\n\n\n\n\n\n\n\n\n\nJOIN US! MRCT Center 2026 Annual Symposium\n\n\n\nThe MRCT Center 2026 Annual Symposium returns to Boston on Wednesday\, October 21\, 2026\, to be held at the offices of Ropes & Gray in Boston. Join us for a full day of discussions and presentations on ethical\, actionable\, and practical solutions to today’s global clinical research challenges. \n\n\n\nOn Thursday\, October 22\, the MRCT Center leads a day dedicated to data sharing\, co-organized with Vivli. \n\n\n\nThe symposium is hybrid\, in-person in Boston\, and online\, and it is free and open to all. Registration is now open. Attend one day or both\, in person or virtually. The keynote and full agenda will be announced in the coming weeks. \n\n\n\nRegister today to secure your spot and help drive responsible innovation in clinical trials. \n\n\n\n    \n    Register Now\n    \n\n\n\n\n\n\nRelated:\n\n\n\nAI in the Operations and Administration of Clinical Trials will be featured at the 2026 MRCT Center Annual Symposium.  \n\n\n\nAs part of this effort\, we request individuals and organizations to share pilots\, tools\, and/or technical solutions. Please contact Trevor Baker (tbaker13@bwh.harvard.edu) if you have or know of such solutions. In addition\, please feel free to introduce us to others you know\, or let us know of others to whom we should reach out.
URL:https://mrctcenter.org/tribe-events/mrct-center-2026-annual-symposium/
CATEGORIES:Meetings
ATTACH;FMTTYPE=image/png:https://mrctcenter.org/wp-content/uploads/2026/07/26-06-30-Annual-Symposium-Graphic_Gen-Pop.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20261105T130000
DTEND;TZID=America/New_York:20261105T153000
DTSTAMP:20260812T093510
CREATED:20251125T173427Z
LAST-MODIFIED:20251125T173429Z
UID:25125-1793883600-1793892600@mrctcenter.org
SUMMARY:Meeting of The Research\, Development\, and Regulatory Roundtable (R3)
DESCRIPTION:The Research\, Development\, and Regulatory Roundtable (R3) is a forum to discuss pre-competitive issues in drug and device development\, regulatory oversight of clinical trials\, and human subjects research. Meetings convene policymakers\, legal counsel\, academicians\, industry representatives\, and global regulators. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP. \n\n\n\nThis hybrid meeting is open to sponsors of the Research\, Development\, and Regulatory Roundtable. \n\n\n\nTopic: TBD \n\n\n\nFor more information\, please email at MRCT@BWH.HARVARD.EDU \n\n\n\n\n\n\n\n\n\n\n\nDeliverables\n\n\n\n\n\n\nProjects\n\n\n\n\n\n\n\n			    October 18\, 2022 \n    Promoting Global Clinical Research in Children ›
URL:https://mrctcenter.org/tribe-events/meeting-of-the-research-development-and-regulatory-roundtable-r3-11/
LOCATION:hybrid
CATEGORIES:Meetings
ATTACH;FMTTYPE=image/jpeg:https://mrctcenter.org/wp-content/uploads/2022/11/R3.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20261201T130000
DTEND;TZID=America/New_York:20261201T150000
DTSTAMP:20260812T093510
CREATED:20260706T164726Z
LAST-MODIFIED:20260713T202508Z
UID:25905-1796130000-1796137200@mrctcenter.org
SUMMARY:Joint Task Force for Clinical Trial Competency (JTF) Global Biannual Meeting
DESCRIPTION:Meeting\n\n\n\n\n\n\n\n\n\n\n\n\n\nThe Joint Task Force for Clinical Trial Competency (JTF)\, anchored at the MRCT Center\, develops and disseminates standards and practices for the global clinical research workforce. By fostering a cohesive and collaborative approach\, the JTF ensures that professionals have the competencies to conduct clinical trials ethically and effectively. \n\n\n\nOur international team of investigators\, educators\, and clinical research professionals has developed and/or utilizes a framework that defines the knowledge\, skills\, and attitudes necessary for conducting safe\, ethical\, and high-quality clinical research. \n\n\n\nJoin us on December 1\, 2026\, 1:00-3:00 PM for the Joint Task Force for Clinical Trial Competency (JTF) Biannual Global Meeting to hear about global perspectives on implementing the JTF Framework.  \n\n\n\nTo learn more about the JTF Framework: https://mrctcenter.org/clinical-trial-competency/framework/overview/ \n\n\n\nAll registrants will receive slides and a meeting summary after the meeting. This event is free.  \n\n\n\n    \n    REGISTER HERE
URL:https://mrctcenter.org/tribe-events/joint-task-force-for-clinical-trial-competency-jtf-global-biannual-meeting-6/
CATEGORIES:Meetings
ATTACH;FMTTYPE=image/png:https://mrctcenter.org/wp-content/uploads/2025/07/2025-12_Biannual-Global-Meeting_JTF_Graphic-06.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20261208T100000
DTEND;TZID=America/New_York:20261208T123000
DTSTAMP:20260812T093510
CREATED:20260409T145109Z
LAST-MODIFIED:20260409T145404Z
UID:25707-1796724000-1796733000@mrctcenter.org
SUMMARY:Meeting of the Bioethics Collaborative
DESCRIPTION:Topic: TBD \n\n\n\nThis meeting is open to sponsors of the MRCT Center Bioethics Collaborative and select invited guests. For more information about the Bioethics Collaborative and how to become a sponsor\, click here.
URL:https://mrctcenter.org/tribe-events/meeting-of-the-bioethics-collaborative-december-8-2026/
ATTACH;FMTTYPE=image/png:https://mrctcenter.org/wp-content/uploads/2022/12/bioethics-1.png
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