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