CDISC and OUCRU Developing Standard to Speed Ebola Research

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The Clinical Data Interchange Standards Consortium (CDISC) and the Oxford University Centre for Tropical Medicine and Global Health have recently begun 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.

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To deliver the most rapid and effective response to the [Ebola] epidemic, a wide network of investigators has agreed to align study outcomes and share results. When planning this collaborative data initiative, CDISC was the global language of choice.

The Clinical Data Interchange Standards Consortium (CDISC) and the Oxford University Centre for Tropical Medicine and Global Health have recently begun 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 Pharmaceuticals Medical 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.

“We are working with various partners and consortia around the world to quickly evaluate potential treatments for Ebola,” said Laura Merson, who is coordinating the project from the Oxford University Clinical Research Unit, Viet Nam. “To deliver the most rapid and effective response to the epidemic, a wide network of investigators has agreed to align study outcomes and share results. When planning this collaborative data initiative, CDISC was the global language of choice.”

“CDISC is committed to streamlining medical research to more rapidly deliver results to clinicians and treatments to patients,” said Rebecca Kush, President, CDISC. “We are very pleased that the CDISC data collection and reporting standards are being implemented for this collaborative research, which is so critical to global safety. We are grateful that CDISC experts have been quick to volunteer, contributing their personal time and expertise toward this end.”

CDISC and Oxford University welcome participation from interested parties to assist on this project or other standards for specific disease areas that are being developed through the Coalition for Accelerating Standards and Therapies (CFAST), a partnership between CDISC and C-Path.

ABOUT CDISC
CDISC is a 501(c)(3) global non-profit charitable organization, with over 350 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop consensus-based industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC standards and innovations can significantly decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safe and effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.

ABOUT Oxford Centre for Tropical Medicine and Global Health
Tropical Medicine and Global Health is a collection of research groups within the Nuffield Department of Clinical Medicine, University of Oxford, who are permanently based in Africa and Asia as well as a growing number of groups in Oxford. Our research ranges from clinical studies to behavioural sciences, with capacity building integral to all of our activities.

The majority of our research is conducted at three Wellcome Trust Major Overseas Programmes in Kenya, Thailand and Viet Nam as well as the Centre in Oxford. Tropical Medicine and Global Health also brings together a number of sister groups in Laos, Tanzania, Indonesia and Nepal, and collaborators around the world.

Tackling infectious diseases, which kill many millions of people every year, is one of the greatest challenges of the 21st century. Scientists at the centre are researching solutions to the increasingly urgent problems these diseases cause. See http://www.tropicalmedicine.ox.ac.uk

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