Focus Area: Clinical Trials & Research

Principles Papers Released

On December 7, 2016, at the MRCT Center Annual Meeting, we released several principles documents that summarize core principles of major MRCT Center projects:

Return of Aggregate Results to Participants Principles

Principles of Post-Trial Responsibilities: Continued Access to an Investigational Medicine

Introducing Vivli

These short principles documents provide a handy summary of major concepts of larger MRCT Center publications and efforts.

2016-12-02-Return-of-Aggregate-Results-to-ParticipantsDownload
2017-06-28-Principles-of-Post-Trial-Responsibilities-Version-1.1Download
2016-12-02-Vivli-OverviewDownload

MRCT Center 2016 Impact Report Released

On December 7, 2016, at the MRCT Center Annual Meeting, we released the MRCT Center 2016 Impact Report.

Transparency has been a special focus of the MRCT Center’s 2016 efforts. We introduced detailed plans for Vivli – an independent Center for Global Clinical Research Data – and we developed a principled framework for the return of individual research results to study participants. The 2016 Impact Report also highlights our work on harmonized core competencies for clinical research professionals, post-trial responsibilities, Bioethics Collaborative, and global regulatory efforts in India and China.

MRCT Center 2016 Impact Report

2016 MRCT Center Impact Report

Post-Trial Responsibilities Framework Version 1.0 Released

On December 7, 2016, at the MRCT Center Annual Meeting, we released Version 1.0 of the MRCT Center Post-Trial Responsibilities Framework: Continued Access to Investigational Medicines – Guidance Document.

A multi-stakeholder workgroup, convened by the MRCT Center, developed this document, which outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial.

MRCT Center Post-Trial Responsibilities Framework

2016-12-07-Post-Trial-Responsibilities-Guidance-DocumentDownload

Launch of Bioethics Collaborative

The MRCT Center is launching a new initiative–the Bioethics Collaborative.

The MRCT Bioethics Collaborative is a forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development. Our meetings will bring together scholars, executives, and scientists from academia and industry to share, define, study, and propose ethical frameworks for topics including human subject protections, biospecimens, and research integrity. We will look at real-life settings as well as develop approaches to address emerging and unanticipated issues as the pace of research continues to accelerate. The Collaborative will be a neutral forum to provide ethical guidance on global clinical trials concerns.

For more information, or if you are interested in joining the Bioethics Collaborative, please contact Rebecca Li at RLi@bwh.harvard.edu.

Proceedings, Presentations and Annual Report Available from MRCT Center’s 2015 Annual Meeting

The MRCT Center 2015 Annual Meeting was held on 15 December 2015 and was attended by about 70 stakeholders from academia, governmental agencies, pharmaceutical industry, patient advocates, non-profit organizations, institutional review boards and others. The MRCT Center 2015 Annual Progress Report was released at the meeting.

The major themes of the MRCT Center 2015 Annual Meeting included Post-Trial Responsibilities and Data Transparency. The Post-Trial Responsibilities (PTR) Working Group developed an Ethics Framework with two main deliverables: a PTR Guidance Document and a PTR Toolkit. Invited speakers shared their perspectives and suggestions for revisions. The Data Sharing and Data Transparency Initiative’s current progress on developing a blueprint for a new, not-for-profit entity was presented. Invited speakers shared their perspectives on the project vision to date.

Proceedings from this meeting are now available. Presentations from the Post-Trial Responsibilities working group and from the Data Sharing and Data Transparency Initiative are available for sponsors.

MRCT Center and Collaborators Published in Journal of Medical Ethics

A multi-stakeholder team, convened by the MRCT Center, published an article detailing use of a Protocol Ethics Toolkit to facilitate effective recognition, consideration and deliberation of critical clinical ethical issues in clinical trial protocols.

The publication, “Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees” has just been released by the Journal of Medical Ethics.

To read the article, click here.

To read a related blog posting, click here.

To learn more about the MRCT Center’s work on Protocol Ethics, click here.

Protocol Ethics E-Learning