CDISC Contact: Andrea Vadakin +1.316.558.0160 avadakin@cdisc.org


FOR IMMEDIATE RELEASE CDISC and OUCRU Developing Standard to Speed Ebola Research


Austin, TX and Oxford, UK – 04 December 2014 – The Clinical Data Interchange Standards Consortium (CDISC) and the Oxford University Centre for Tropical Medicine and Global Health are collaborating to develop a global standard to assist in the collection, aggregation and analysis of Ebola virus disease (EVD) research data. This standard will be for use in EVD trials, leading to potential treatments and public health surveillance for this disease.


Oxford University researchers and CDISC standards developers are applying existing, globally accepted CDISC standards for core research data and virology to annotate Ebola-specific case report forms (CRF) that will be used in the collection and management of data from patients enrolled to clinical trials of interventions for Ebola virus disease. Investigators from a number of institutions, planning trials of investigational medicinal products and convalescent blood products, have agreed to implement the standard in order to facilitate advances in data-sharing practices. Having this data in CDISC standard format will allow for more efficient aggregation and analysis of data collected from various studies and locations around the world, thereby leading to an enhanced, automated process for developing evidence in evaluating Ebola treatments. The CDISC global data standards are also encouraged by the U.S. Food and Drug Administration, the Innovative Medicines Initiative in Europe and Japan’s PharmaceuticalsMedical Devices Agency and Translational Research Informatics Center.


Oxford University has received funding for therapeutic trials in EVD from the Wellcome Trust and is collaborating with other organizations conducting clinical research, including the Institute of Tropical Medicine, Antwerp; the London School of Hygiene and Tropical Medicine, Medecins Sans Frontieres (Doctors without Borders), Institut National de la Sante et de la Recherche Medicale (INSERM) and the World Health Organization (WHO) to align data for the most robust and useful results. The Institute of Tropical Medicine project is funded by the European Union, the Wellcome Trust and the Flemish government. This global, cross-study data alignment will be enabled through consensus-based CDISC standards. CDISC collaborators and volunteers contributing to this effort, led by Shannon Labout, CDISC VP of Education, are from numerous organizations, including Accenture, Biogen Idec, Business & Decision Life Sciences, Critical Path Institute, Covance, CSL Behring, Eli Lilly and Company, GDU Clinical Trials Consulting, GlaxoSmithKline, InClin, Johnson & Johnson, Joyce Hernandez Consulting, KCT Data, Pharmastat, Quintiles, Takeda, UCB, the Worldwide Antimalarial Resistance Network (also developing CDISC standards for malaria research), as well as other organizations.


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