The MRCT Center, in collaboration with CDISC, is thrilled to present the newly expanded and re-designed Clinical Research Glossary. With the dedicated efforts of numerous volunteers, the original content has been updated, and more than a hundred new terms have been added. Highlights include specialized information to help support participants, and tailored, shareable images to foster engagement and understanding. Please join us on April 2nd at noon EST to learn more about what’s changed and explore all the ways in which this Clinical Research Glossary meets the needs of participants and the clinical research industry.
Introducing Research Ethics Action Collaborative for HRPPs (REACH), an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham. This effort aims to curate, align, and disseminate tools to advance access to and inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community.
We invite you to join an engaging webinar scheduled for Thursday, March 7 from 12 – 1:00 PM ET. This interactive session will explain the motivation behind this effort and explore actionable strategies to operationalize inclusion efforts in HRPPs.
The key discussion points include:
Making the Case for Leadership: Understand the significance of integrating inclusion and accessibility within HRPPs and explore effective ways to articulate a compelling case that resonates with stakeholders and leadership.
Establishing a Roadmap for Change: Delve into the process of creating a roadmap for change, navigating institutional processes, and garnering leadership buy-in to ensure a sustainable and impactful implementation of inclusion in HRPPs.
Presenting Resources: Explore resources available to IRBs, HRPPs, and institutions currently freely available, and provide a means for attendees to identify additional tools needed for this work.
Soliciting Examples: Hear from participants about successful practices and strategies implemented within their respective institutions, fostering a dynamic exchange of insights and best practices.
Join us in this collective endeavor to actively strategize and operationalize efforts within IRBs and HRPPs.
December 13, 2023
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8:00 am
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December 14, 2023
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12:00 pm
Ropes & Gray, Boston, MA
800 Boylston Street Boston,
Massachusetts
02199United States
Wednesday, December 13
Note: the location for meetings on Thursday, December 14 is different: Loeb House at Harvard University, 17 Quincy Street, Cambridge, MA 02138
Please join us December 13 – 14 in Boston for our 2023 Annual Meeting. The enhanced two-day program features a keynote address from Peter Arlett, Head of Data Analytics and Methods at the European Medicines Agency (EMA), several panel presentations, and Research & Regulatory Roundtable (R3) and Bioethics Collaborative (BC) sessions, all open to registrants at no cost.
While in-person attendance is encouraged, virtual participation is welcome.
The objective of this meeting was to provide an update to all stakeholders regarding current initiatives and progress, engage regulators in the MRCT Center initiatives and mission, obtain feedback from regulators and stakeholders on MRCT Center’s ongoing and planned initiatives, and discuss the 2013 Budget and Proposed Goals.
The MRCT Center Annual Meeting provided an opportunity to update stakeholders on current initiatives and discuss key Clinical Data Sharing Projects including, Practical Implementation of Clinical Trial Data Sharing and Return of Individual Results to Patients.
The MRCT Center 2015 Annual Meeting was held on 15 December 2015. The major themes of the MRCT Center 2015 Annual Meeting included Post-Trial Responsibilities and Data Transparency.
Key themes of the meeting were: Discussion of the impact of the newly released ICH E17 Guidelines, and Data Transparency (sharing data with researchers and individual participants). This meeting is for all MRCT Center stakeholders.
Henrietta’s Table, Charles Hotel, 1 Bennett St, Cambridge, MA 02138
5:30 pm – 8:30 pm — Conference Dinner
Invited guests include: Executive and Steering Committee Members, Conference Speakers and Discussants, and Individual Return of Results Working Group Members
Preregistration is required.
Wednesday, December 7, 2016
Loeb House, 17 Quincy Street, Cambridge, MA 02138
7:30 am – 8:00 am — Breakfast and Registration
8:00 am – 8:15 am — Welcome and Introductions
8:15 am – 9:15 am — Discussion of the Impact of Draft ICH E17 Guidelines
Laurie Letvak, Head of Clinical Policy and Medical Ethics, Chief Medical Office, Novartis Pharmaceuticals Corporation
William Wang, Executive Director, Biostatistics and Research Decision Sciences, Merck & Co., Inc.
Moderator: Mark Barnes, Faculty Co-Director, MRCT Center, Partner, Ropes & Gray Followed by group discussion and Q&A
9:15 am – 10:45 am — Data Sharing and Data Transparency
Keynote Session: Data transparency today and tomorrow: current state, issues, and vision
Murray Stewart, Chief Medical Officer, GlaxoSmithKline
Progress in 2016 and outlook to 2017
Rebecca Li, Executive Director, MRCT Center; Instructor in Medicine, Center for Bioethics, Harvard Medical School
Responses from key stakeholders
Jeffrey Drazen, Editor-in-Chief, New England Journal of Medicine
Amita Gupta, Associate Professor of Medicine and International Health, Center for Clinical Global Health Education, Johns Hopkins University
Murray Stewart, Chief Medical Officer, GlaxoSmithKline
Moderator: Rebecca Li, Executive Director, MRCT Center; Instructor in Medicine, Center for Bioethics, Harvard Medical School Followed by group discussion and Q&A
11:00 am – 12:30 pm — Individual Return of Results Working Group
Remit of the Working Group and Overview of IRR Principles
Debra JH Mathews, Assistant Director for Science Programs, Berman Institute of Bioethics, Johns Hopkins University
David Pulford, Genetics TA Head Rare Diseases, GlaxoSmithKline
Sandra Prucka, Innovation Lead, Clinical Innovation, Eli Lilly and Co.
Responses from key stakeholders
Atul Gawande, Director, Ariadne Labs, Professor, Harvard T.H. Chan School of Public Health
Barbara LeStage, Steering Committee Member, Clinical Trials Transformation Initiative
Alvaro Pascual-Leone, Director, Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Professor of Neurology, Harvard Medical School
Holly Taylor, Core Faculty Member, Berman Institute of Bioethics, Johns Hopkins University, Associate Professor, Department of Health Policy and Management, Bloomberg School of Public Health
Moderator: Barbara Bierer, Faculty Co-Director, MRCT Center; Professor of Medicine, Harvard Medical School
Followed by group discussion and Q&A
12:30 pm – 12:45 pm — Closing Remarks
12:45 pm – 1:15 pm — Lunch
Meeting of the Executive Committee and Steering Committee
1:15 pm – 5:00 pm — Update and discussion of ongoing MRCT Center projects
Click here to view the Annual Meeting Slides (for sponsors only).
The principal topics discussed at the MRCT Center 2018 Annual Meeting were:
European Union General Data Protection Regulation (GDPR)
Representation of Diverse Populations
Advancing the Study of Clinical Trials
Capacity Building
Health Literacy in Clinical Research.
The meeting was followed by the Executive and Steering Committee meeting in the afternoon (1:00 PM -5:00 PM), which was open to MRCT Center sponsors only.
The MRCT Center Annual Meeting was held in the morning of December 4, 2019 (8:00 AM -1:00 PM). The keynote speaker was Professor Chenguang Wang, Tsinghua University Law School.
Click here to view the Annual Meeting Slides (for sponsors only).
The principal topics discussed at the MRCT Center 2019 Annual Meeting were:
Life sciences Regulation and Policy in Today’s China
Health Literacy in Clinical Research
Real World Evidence – OPERAND
Representation and Inclusion of Diverse Populations in Clinical Research
EU General Data Protection Regulation (GDPR)
The meeting was followed by the Executive and Steering Committee meeting in the afternoon (1:00 PM -5:00 PM), which was open to MRCT Center sponsors only.
