Publication
Published on: January 28, 2023
Published in: Pediatric Research
Establishing a Global Regulatory Floor for Children’s Decisions about Participation in Clinical Research
Focus Area: Clinical Trials & Research
Part 2: The Regulation of Research Involving Cannabis
September 20, 2022 @ 2:00 pm – 4:00 pm
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.
Deliverables
Projects
Meeting Summary
Released on: September 20, 2022
Topics: 1) Legal and Regulatory Perspectives of For-Profit Research Sites, and 2) The Regulation of Research Involving Cannabis
MRCT Center 2022 Annual Meeting Slides
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MRCT Center 2022 Annual Meeting Proceedings
Proceedings
Presented on: December 14, 2022
Presented at: “MRCT Center Annual Meeting, Ropes & Gray, Boston, MA
Standardizing and Measuring Principal Investigator and Site Qualifications for Conducting Clinical Trials Workshop
September 18, 2012 @ 8:00 am – 4:00 pm
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
For more information please see the links below.
2012-09-18 Principle Investigator Workshop Proceedings
2012-09-18 Principle Investigator Workshop Agenda
Deliverables
Projects
MRCT Center Annual Meeting
November 28, 2012 @ 8:00 am – 4:30 pm
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.
For more information please see the links below.
2012-11-28 MRCT Center Annual Meeting Agenda
2012-11-28 MRCT Center Annual Meeting Slides
2012-12-17 MRCT Center Annual Meeting Proceedings
Deliverables
Projects
MRCT Center Annual Meeting
December 4, 2013 @ 7:30 am – 5:00 pm
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.
For more information please see the links below.
2013-12-04 MRCT Center Annual Meeting Agenda
2013-12-04 MRCT Center Annual Meeting Proceedings
Deliverables
Projects
MRCT Center Annual Meeting
December 3, 2014 @ 7:30 am – 4:00 pm
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.
For more information please see links below.
2014-11-26– MRCT Annual Meeting Agenda
2014-12-03 MRCT Annual Meeting Slides
2014-12-03 MRCT Annual Meeting Proceedings
Deliverables
Projects
MRCT Center Annual Meeting
December 15, 2015 @ 7:30 am – 5:00 pm
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.
For more information, please see links below.
2015-12-15 MRCT Center Annual Meeting Agenda
2015-12-15 MRCT Center Annual Meeting Proceedings
2015-12-15 MRCT Center Annual Meeting Slides
Deliverables
Projects
MRCT Center Annual Meeting
December 7, 2016 @ 7:30 am – 5:00 pm
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
Data Sharing For The Public Good Agenda
Tuesday, December 6, 2016
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
- 2017 Initiatives
- Discussion of new projects
Deliverables