Approach For Reporting Master Protocol Study Designs on ClinicalTrials.gov: Qualitative Analysis

Publication

Published on: June 10, 2022

Published in: BMJ

Deborah Zarin, MRCT Center Program Director, co-authored “Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis,” published in BMJ. The authors describe an approach for reporting master protocol research programs that is consistent with existing good reporting practices and that uses structured information to convey the overall master protocol and design of each substudy.

MRCT Center 2022 Annual Meeting Slides

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Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions

May 17, 2013 @ 7:30 am 5:00 pm

Harvard Law School, Wasserstein Hall, Millstein East, Cambridge, MA

In light of recent decisions by the European Medicines Agency (EMA) there is likely to be a call for an increased level of data sharing including from other regulatory agencies. The objectives of this meeting were to provide a forum for discussion of the rationales and implications of this paradigm change and to begin to consider potential solutions.

For more information please see links below.

2013-05-17 P-C MRCT GHI Meeting Proceedings

2013-05-17–MRCT-PFC Agenda

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

Promoting Clinical Trial Data Transparency Conference

March 30, 2015 @ 8:00 am 5:00 pm

Harvard Faculty Club, Cambridge, MA

During two days, March 30 – 31, 2015 over seventy committed international stakeholders joined together to deliberate how to promote and coordinate clinical trials data transparency. 

For more information please see link below

2015-03-31 Data Sharing Conference Agenda

2015-3-31 Data Sharing Conference Proceedings

Deliverables

Projects

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

Conference on the Future of Clinical Trial Data Sharing

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

London

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 mrct@bwh.harvard.edu

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