Collaborative Innovation Between CDISC and IMI Facilitates Development of Global Standards

CDISC has long proven itself to be a catalyst for collaborative innovation, as evidenced through the many opportunities it has created for partners and stakeholders to streamline the medical research processes. Recent releases of CDISC consensus-based data standards for tuberculosis, Alzheimer’s disease, Parkinson’s disease, pain and polycystic kidney disease are examples.

In 2011, the Innovative Medicines Initiative (IMI) and the Clinical Data Interchange Standards Consortium (CDISC) signed a Memorandum of Understanding to outline the collaboration between the two organizations. It was agreed that common data standards and formats are necessary to effectively pool, manage and analyze information both within and across IMI projects. In 2012, through the CDISC Europe Foundation (CEF), CDISC became a partner on three IMI project consortia: EHR4CR, BioVacSafe, and most recently eTRIKS.[1][2][3] Additional IMI consortia are using CDISC standards, and CDISC is providing education and training as well as data standards expertise to assist in integration of both prospective and retrospective clinical research data.

IMI Executive Director Professor Michel Goldman commented: “IMI is committed to collaborating with partners like CDISC to share data, ideas and experience to avoid the duplication of effort. Only by working together in this way can we hope to speed up the development of new treatments to tackle deadly and debilitating diseases.”

Looking forward, CDISC is co-leading the data standards work package for eTRIKS with Roche and IDBS. Building upon the open source tranSMART system, eTRIKS aims to 1) enable data integration, 2) build a common set of standards, 3) increase operational efficiency and 4) ensure the legacy of translational research data generated in IMI and other European projects focused on therapeutic areas such as severe asthma, rheumatoid arthritis, depression and schizophrenia, multiple sclerosis, tuberculosis and several types of cancer. This aligns well with the ongoing and planned development of new CDISC Therapeutic Area Standards, including schizophrenia, oncology, asthma and diabetes.

CDISC also continues to develop standards in the therapeutic areas through the tremendous support of its many members and volunteers, as well as collaborating entities such as TransCelerate Biopharma and the U.S. Food and Drug Administration (FDA). The CDISC consensus-based standards development process encourages collaboration amongst these diverse companies and organizations, thus resulting in true global standards. “CDISC’s collaboration with IMI and participation in key IMI projects creates a great opportunity to align Therapeutic Area Standards projects and priorities among IMI, TransCelerate Biopharma, FDA, global biopharmaceutical companies, patient foundations and others. This sets the stage to ensure therapeutic area standards development is well synchronized globally,” stated Mr. Kisler, CDISC VP, Strategic Alliances.

[1]Electronic Health Records for Clinical Research: http://www.ehr4cr.eu
[2]Biomarkers for Enhanced Vaccine Immunosafety: http://biovacsafe.eu
[3]European Translational Research Information & Knowledge Management Services: http://www.etriks.org