Conference on the Future of Clinical Trial Data Sharing

March 21, 2016 @ 9:00 am 5:00 pm


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



Global Simultaneous Drug Development Workshop, Beijing

May 21, 2016 @ 8:00 am 5:00 pm

Bejing, China

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



Core Competencies in Clinical Research: Real World Applications, Convergence and Evolution of a Framework

October 19, 2016 @ 8:00 am 4:00 pm

Harvard Faculty Club, Cambridge, MA

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.

October 19 Workshop Agenda

Proceedings from Core Competencies Workshop


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



Expanded Access to Investigational Medicines

October 24, 2016 @ 11:30 am 4:00 pm

Ropes & Gray, Boston, MA

800 Boylston Street
Boston, Massachusetts 02199 United 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.