The Clinical Research Glossary: New Words, New Opportunities

April 2, 2024 @ 12:00 pm 1:00 pm

Remote

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.

Webinar topics include:

  • Building trust and transparency with participants through plain language information sharing.
  •  The dedicated team members and robust process that is followed to create this global standard.
  • Strategies and approaches to implement the Clinical Research Glossary content into patient-facing materials. 

Research Ethics Action Collaborative for HRPPs (REACH) webinar

March 7, 2024 @ 12:00 pm 1:00 pm

Remote

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.

MRCT Center Annual Meeting

December 13, 2023 @ 8:00 am December 14, 2023 @ 12:00 pm

Ropes & Gray, Boston, MA

800 Boylston Street
Boston, Massachusetts 02199 United 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.

Click here to register.

Click here for detailed information, including Frequently Asked Questions (FAQ)

Related Resource

MRCT Center Annual Meeting

November 28, 2012 @ 8:00 am 4:30 pm

Harvard Faculty Club, Cambridge, MA

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

Loeb House at Harvard University, Cambridge, MA

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

MRCT Center Annual Meeting

December 15, 2015 @ 7:30 am 5:00 pm

Harvard Faculty Club, Cambridge, MA

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

Harvard Faculty Club, Cambridge, MA

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

Projects

MRCT Center Annual Meeting

December 6, 2017 @ 8:00 am 1:00 pm

Loeb House at Harvard University, Cambridge, MA

MRCT Center 2017 Annual Meeting Agenda

MRCT Center 2017 Annual Meeting Proceedings

MRCT Center 2017 Annual Meeting Slides

MRCT Center 2017 Annual Meeting Keynote Slides

Key themes of the meeting included MRCT Center projects:

  • Introducing a new project: Real World Evidence
  • Core Competencies for Clinical Research Professionals
  • Return of Individual Results: Genomics and Axes of Communication
  • Preview: Global Clinical Trial Data Sharing Platform

The MRCT Center Annual Meeting is open to all MRCT Center stakeholders and the public.

1:00 PM- 4:30 PM, the MRCT Center Executive and Steering Committee met in closed session.

Deliverables

Projects

MRCT Center Annual Meeting

December 5, 2018 @ 8:00 am 5:00 pm

Loeb House at Harvard University, Cambridge, MA

The MRCT Center Annual Meeting was held in the morning of December 5, 2018 (8:00 AM -1:00 PM).

The keynote speaker was Guido Rasi, Executive Director of the European Medicines Agency (EMA).

Click here to view the Annual Meeting Agenda.

Click here to view the Annual Meeting Proceedings

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.

Deliverables

MRCT Center Annual Meeting

December 4, 2019 @ 8:00 am 5:00 pm

Loeb House at Harvard University, Cambridge, MA

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 Agenda.
  • Read more about the Keynote Speaker, Professor Chenguang Wang
  • Click here to view the Annual Meeting Proceedings
  • 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.

Deliverables