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.
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).
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.
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
800 Boylston Street Boston,
Massachusetts
02199United States
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.