As more states move to legalize marijuana, the regulatory landscape is becoming increasingly complex. The number of sponsors and researchers inquiring about these regulations has also increased. Clinical research involving cannabis is subject to both federal and state regulations. Key regulatory frameworks include DEA regulations on the use of controlled substances in research studies, FDA IND regulations, and state law. Proposed federal legislation may also affect the conduct of research involving cannabis. David Peloquin, MRCT Center Senior Advisor and Partner at Ropes & Gray LLP, provided an overview of DEA and FDA regulations relating to research involving cannabis, reviewed recent legislative developments, and discussed state-level policies and challenges using New York state as an example.
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The objective of this workshop was to agree on a consensus list of “key selection standards or criteria for sites and Principal Investigators,” to propose methods to quantify the importance of these criteria, and to make recommendations for the MRCT Center’s role moving these issues forward
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 Harvard MRCT Annual Meeting 2014 focused on the Guidance Document and Toolkit that the Harvard MRCT workgroup developed for returning aggregate results to study participants and included a panel with various stakeholder perspectives on returning of results. In addition, Harvard MRCT co-directors introduced their work of addressing regulatory, trial causality and compensation issues in India.
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
800 Boylston Street Boston,
Massachusetts
02199United States
Convening representatives from academia, industry, and government, this conference explored the impact of the EU GDPR on human subjects research, highlighting the challenges posed by the GDPR to clinical research, biobanking and databanking, and big data research, particularly in light of the limited guidance available to date from EU and EU member state authorities.
