Focus Area: Quality & Transparency

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 wins the 2015 Award for Excellence in Human Research Protection

The 2015 Awards for Excellence in Human Research Protection were announced on December 28th by Dr. Peter G. Goldschmidt, President and Founder of Health Improvement Institute, “The award program recognizes submissions that our judging panel determines have demonstrated excellence in promoting the well-being of human research participants.”

The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard won the 2015 Annual Award for Best Practice for the MRCT Return of Results Guidance Document and MRCT Return of Results Toolkit.

This toolkit and guidance document provides guidance and examples for disseminating non-technical summaries to participants of clinical trials, and have been used in Europe to draft equivalent materials for both the EU and UK. These materials are currently being adapted for use in South Korea for non-Western and integrative medicine.

Launch of Data Sharing Working Groups

The Multi-Regional Clinical Trials Center of Harvard and Brigham and Women’s Hospital (MRCT Center), the Wellcome Trust, and the Arnold Foundation have spearheaded a major initiative related to sharing of clinical trials data, to enable stakeholders to comply with PhRMA, EFPIA, EU and IOM guidelines on clinical trial data sharing: sharing participant level data with researchers.\

To advance this initiative, we convened stakeholders from the US, Europe and WHO who decided that a global, federated portal of all datasharing sites from industry, academia and ideally government would take clinical trial data sharing to the next level.

A unified data sharing model emerged from 70 participants at a data transparency conference at the Harvard Faculty Club in late March 2015: an empowered multi-stakeholder non-profit governance structure with authority and accountability for the data sharing initiative that will have a central user interface with robust search engine for trials from around the world. The data platform will have the flexibility to host data and the ability to download data freely or to process data requests via independent review panels.

After the March meeting, three work streams were convened:

IOM/MRCT Information Technology (IT) Work Stream

  • To develop specifications for a technical infrastructure of a global platform to encourage and facilitate broad-based sharing of clinical trials data for scientific purposes
  • To commission research and a report of state-of-the-art IT infrastructure for data sharing platform and needs (Fall 2015), draft blueprint/framework for IT infrastructure (Dec 2015), develop detailed IT specifications (March 2016), issue Request for Proposal (March 2016) and get platform built in 2017

Governance Work Stream

  • To develop high-level charter with vision, mission and principles for governance structure and;
  • To develop criteria for roles and responsibilities for a steering committee
  • To establish an empowered committee (Spring 2016), obtain seed funding to establish non-profit entity (2017)

Business Models Work Stream

  • To develop sustainable business models for the new entity and;
  • Advise the governance workgroup on how to develop and capacitate the not-for-profit entity, including in regard to its financial viability