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Data Sharing & Transparency Initiative

Focus Area: Data Transparency

Data Sharing & Transparency Initiative

Project background:

In light of regulatory action by the European Medicines Agency (EMA) there has been a call for an increased level of data sharing including from journal editors and other key stakeholders. MRCT Center of Brigham and Women’s Hospital and Harvard focused our multi-stakeholder base on providing a forum for discussion of the rationales, barriers and implications of this paradigm change and to formulate potential solutions.

The MRCT Center, the Wellcome Trust, the Institute of Medicine (IOM), the Laura and John Arnold Foundation (LJAF) and Deloitte Consulting 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: facilitating broad stakeholder clinical trials data sharing and sharing participant level data with researchers.

To advance this initiative, the MRCT Center convened stakeholders from the US, Europe and international organizations (WHO, academics) who decided that a global, federated portal of all data sharing sites from industry, academia and government would most effectively promote and facilitate the sharing of clinical trials data.

A unified data sharing model emerged from 70 participants at an MRCT Center Data Transparency conference at the Harvard Faculty Club in March of 2015: an empowered multi-stakeholder non-profit organization with authority and accountability to implement the data sharing initiative, which will have a central user interface with robust search engine to obtain clinical trial data from around the world. The data-sharing platform will have the flexibility to host data, the ability to download data freely and the ability to process data requests through independent review panels.

After the March meeting, three work streams were convened in the summer of 2015:

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, draft blueprint/framework for IT infrastructure, develop detailed IT specifications, and issue a Request for Proposal to identify an appropriate partner to build the IT platform

MRCT 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 the new entity steering committee,
  • To establish an empowered committee, obtain seed funding to establish non-profit entity

Wellcome Trust/MRCT 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

Current status:

We are now developing the blueprint for a new not-for-profit organization. This new entity will take shape through three phases of realization: strategy, construction and implementation. We are currently working through the strategy phase.

Impact:

Development of a framework for data sharing will enable industry, academics, biotech and other data generators to initiate the process of increased sharing of clinical trials data

Objectives:

To create a new not-for-profit entity whose goal is to create, direct, implement and oversee a sustainable data sharing platform.

Data Sharing: Future Vision

  • Organizational structure and Governance – A coordinating, centralized, international, not-for-profit organization with accountability;
  • A centralized and single portal – A central user interface with a robust search engine functionality, including information on trials around the world;
  • Data requirements – Data standards, definition, data ontology and metadata to allow for and enable the integration of differing datasets for analysis;
  • Shared or common services – Efficient shared or common services across data generators/sponsors (e.g. policy setting, data de-identification, criteria for independent review panel decisions or reliance, and statistical services); and
  • Flexibility – Data platform accommodating differing expectations and research needs, including ability to host data for those data generators that do not wish to or cannot do so themselves, access data that is hosted elsewhere, or download data if freely available. Ability to utilize middleware to perform analyses.

DataTransp_graphic

Key Project Milestones

March 30-31, 2015:
MRCT Center Promoting Clinical Trial Data Transparency Conference
Key stakeholders in the industry, government, academia and non-profit sectors, and patient advocate representatives, convened at Harvard to discuss a future vision for global clinical trial data sharing.

Spring 2015:
Launch of the MRCT/Wellcome Trust Data Sharing Governance Workgroup
This multi-stakeholder workgroup, comprised of members from industry, academia and non-profit sectors is comprehensively addressing the remit and vision of the new data sharing entity and governing principles that will guide its inception.

Summer 2015:
Launch of the MRCT/IOM Data Sharing IT Workgroup
This workgroup is a partnership between the MRCT Center and the Institute of Medicine, comprised of members from industry and academia with focused IT expertise to develop key specifications for a new data-sharing platform.

Fall 2015:
Launch of MRCT/Wellcome Trust Data Sharing Business Models Workgroup
As a collaborative effort of the MRCT Center and Wellcome Trust and with support from Deloitte Consulting, this workgroup is developing a sustainable business model to ensure the work of the data-sharing project is sustainable and viable long into the future.

Winter 2015
Completion of Use Cases for the Data Sharing Platform
The workgroups completed the collection of use cases that will inform the required specifications for the data platform

March 2016
The Future of Clinical Trial Data Sharing Conference
The MRCT Center, in collaboration with The Wellcome Trust, held a conference on “The Future of Clinical Trials Data Sharing” in London. The main theme of the conference was the presentation of plans for Vivli, a new entity for global data sharing.

For more information regarding Vivli’s formation.

Related external links:
IOM Report: Strategies for Responsible Clinical Trial Data Sharing