During this 2-day, March 21-22, 2016, invitation-only meeting, the MRCT Center and collaborators will present plans to launch a new not-for-profit organization charged with directing, implementing and governing a global clinical trial data-sharing platform.
2016-03-16 FINAL Agenda MRCT Wellcome Data Sharing Meeting
Wellcome Conference Proceedings 18 April 2016
For more information please email mrct@bwh.harvard.edu
To facilitate discussion on acceleration of simultaneous drug development around the world, Beijing Biometrics Association (BBA) – Beijing Biometrics Forum (BBF) organized this joint symposium on recent advances in the design and conduct Multi-Regional Clinical Trials (MRCTs).
For more information, please click below.
2016-04-28 China MRCT workshop_Final
The MRCT Center will host a workshop to discuss the evolution of a harmonized framework of core competencies for clinical research professionals and its application to real world experiences.
Fifteen real life case studies applying the core competencies by industry, professional societies and academia in the US and global settings will be presented.
This will be an opportunity to learn more about the application of the core competencies for those seeking to apply the competencies in their own environment. Also the workshop will provide an opportunity for participants to provide feedback and discuss potential future revisions for the competency framework. Potential future projects for the work group will also be discussed.
For registration, please click here.
Proceedings from Core Competencies Workshop
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.
MRCT Center 2016 Annual Meeting Agenda Dec 7
MRCT Center 2016 Annual Meeting Slides
MRCT Center 2016 Annual Meeting Proceedings
Tuesday, December 6, 2016
Henrietta’s Table, Charles Hotel, 1 Bennett St, Cambridge, MA 02138
5:30 pm – 8:30 pm — Conference Dinner
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
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
Progress in 2016 and outlook to 2017
Responses from key stakeholders
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
Responses from key stakeholders
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
The administration of an investigational product via Expanded Access is not meant to answer questions about the product’s safety and effectiveness; rather, it is intended to treat an individual patient with a serious or immediately life-threatening disease or condition for which no satisfactory alternative therapy exists. In the absence of robust guidance for assessing requests for expanded access, physicians and sponsors are left without a critical understanding of the legal, ethical, and financial considerations that ought to influence expanded access determinations.
