The Innovative Medicines Initiative (IMI) has announced an agreement with the US-based Clinical Data Interchange Standards Consortium (CDISC) that will see IMI project teams adopt CDISC formats and standards to harmonise data management across the two organisations.

The move was spearheaded by Ann Martin, principal scientific manager for knowledge management at IMI, the public-private partnership established four years ago by the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) to accelerate the development of better and safer medicines.

As Martin noted, effective information management across the variety of projects undertaken by the IMI calls for “a common format at the elemental level”. The IMI stakeholders felt strongly that it was good practice to adopt data standards, while CDISC standards in the field have been widely adopted by the pharmaceutical industry, she pointed out.

For example, the EFPIA partners involved in IMI projects are already members of the Clinical Data Interchange Standards Consortium, a non-profit organisation affiliated with the US Food and Drug Administration and committed to developing and supporting global, platform-independent data standards that enable information system interoperability in medical research and related areas of healthcare.  

 “The CDISC standards therefore could be considered as a default standard for research conducted through the IMI projects,” Martin said.

Global healthcare standards

An additional benefit is that CDISC not only focuses on global clinical research but works to harmonise with global healthcare standards bodies such as the International Organization for Standardization (ISO), Health Level Seven International (HL7) and the European Committee for Standardization (CEN).

The CDISC suite spans the research process from study protocols through to data analysis and reporting. The Consortium also provides enablers for the use of electronic health records in research.

Over the past few years, CDISC has become increasingly involved in developing data formats to support specific disease areas such as tuberculosis (working with the TB Alliance, the Gates Foundation and the Critical Path Institute (C-Path)), Alzheimer’s disease (also with C-Path, which signed a Memorandum of Understanding for knowledge exchange with IMI in June), Parkinson’s disease, pain, oncology and other therapeutic areas.

What IMI gains

The agreement between CDISC and IMI will provide IMI consortia members with CDISC education and materials, CDISC membership, and access to the CDISC Members Only Area and portals for all academic institutions, small and medium-sized enterprises and other organisations receiving IMI funding as part of the Initiative’s projects.

IMI project teams will use CDISC formats and standards where applicable; when these are not available, they will participate in developing CDISC formats and standards.

“CDISC is extremely pleased to formalise this relationship with IMI,” commented Dr Rebecca Kush, the Consortium’s president and chief executive officer.

“We have thoroughly enjoyed working with IMI to date, and we feel that this will be an invaluable mutually beneficial partnership that can generate standards-based innovations to streamline the development of new therapies and medical knowledge that will benefit patients worldwide.”

The Consortium is now also a full participant in a number of IMI consortia through its CDISC Europe Foundation.