CDISC and EORTC: implementing standards for cancer clinical trials in Europe

22/02/2012

CDISC significantly expanded its presence in Europe in 2011 and anticipates this trend will continue. CDISC has long had a presence in Europe through its European CDISC Coordinating Committee (E3C) founded in 2002, annual CDISC European Interchanges and partnerships with European organizations in the global healthcare and medical research industries. CDISC now adds to this list a newly established CDISC entity in Brussels, Belgium, a recently signed Memorandum of Understanding (MOU) with the EU’s Innovative Medicines Initiative (IMI), and a new relationship with the European Organisation for Research and Treatment of Cancer (EORTC), the EU’s largest cancer research network.

Austin, Texas, 16 February 2012

With CDISC’s expanded efforts in Europe, there is great excitement and anticipation surrounding the upcoming 2012 CDISC European Interchange, set for 16-20 April in Stockholm, Sweden. The Plenary session will begin with opening remarks by the CDISC Board Chair, Paula Brown Stafford and Chair-elect Pierre-Yves Lastic, who has also led the E3C for the past two years. Plenary speakers will be an expert line-up: Professor Marie Lindquist of the Uppsala Monitoring center, who is working with CDISC and the World Health Organization (WHO) on an important project; Dr. Bernard de Bono of the European Bioinformatics Institute, who will speak about some of the IMI initiatives in which CDISC is involved; Ms. Lisa Spellman, Secretariat of the International Standards Organisation’s (ISO) Technical Committee on healthcare standards (TC215); representatives from the U.S. Food and Drug Administration (FDA); CDISC President, Dr. Rebecca Kush and new CDISC Chief Technology Officer, Wayne Kubick. The EU Interchange week will also include the Annual Meeting of the CDISC Board of Directors and a CDISC Advisory Board (CAB) meeting. “We are extremely pleased to have such a qualified, diverse and relevant set of Plenary session speakers, and the presentations to follow have been carefully selected from excellent abstracts on real-world implementation experiences with CDISC standards globally,” commented Dr. Lastic of Sanofi. “We hope to attract those who have attended before in addition to a new set of attendees in new areas where CDISC standards are now developing significance, such as devices, biotechnology and therapeutic areas. With the CDISC entity in Europe, the opportunities for CDISC continue to expand exponentially here.”

The CDISC Europe Foundation was established as a non-profit entity in Brussels, Belgium in July 2011. This newly established entity will assist CDISC in meeting the needs of its Europe-based members, including IMI, by offering localized support and participation in projects and events located throughout the continent. “I’m really excited about CDISC’s growing footprint in Europe that has come about through the CDISC Europe Foundation,” said Bron Kisler, VP Strategic Initiatives at CDISC. “In a short period of time it has enabled CDISC to become a partner organization on several key IMI projects (such as BioVacSafe, EHR4CR and eTRIKS). I see the CDISC Europe Foundation as a springboard to strengthen and expand relationships with existing European members as well as forging new relationships.” Through the CDISC Europe Foundation, CDISC now has the opportunity to be a full partner in IMI projects. Through the MOU with IMI, all of the nonprofit and academic organizations and SMEs participating in IMI projects also receive the benefits of a CDISC Platinum membership. CDISC has provided training to representatives of the majority of the IMI projects through its course: “A Global Approach to Accelerating Medical Research.” Another such training session is planned later in 2012 for those who missed the one in 2011.

Another area of expansion for CDISC in Europe will be in field of therapeutic area standards development. In the United States, CDISC has had a very important relationship with the National Cancer Institute (NCI) for nearly a decade. For example, NCI standard data collection forms are aligned with CDISC’s CDASH standard and NCI hosts the controlled terminology for CDISC and FDA. It is beneficial to now have a similar European network (EORTC) focused on the area of Oncology that is interested in implementing current CDISC standards as well as being involved in further work to establish new standards in this area.

“We look forward to building upon these European opportunities and having an excellent turnout at our CDISC European Interchange in Stockholm in April” said CDISC Board Chair Paula Brown Stafford of Quintiles. “As a leader in a global clinical research organization that services research efforts across the entire spectrum, it is critical to ensure that Europe is integrally involved in our global strategic goals, including translational research, for CDISC in 2012 and beyond.”

 

About CDISC

CDISC is a 501(c)(3) global non-profit charitable organization, with nearly 300 supporting member organizations from across the clinical research and healthcare arenas. The CDISC Europe Foundation is a European non-profit entity. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop 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 innovations can decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.

Contact Information 
Diana Harakeh
CDISC
+1 512 689 9646

 

About the EORTC

The EORTC is a unique organization – a vibrant example of the fact that science and research know no national boundaries. Established in 1962, the EORTC is a non-profit research organization operating as an international association under Belgian law.

The EORTC currently links a network of more than 2.500 pre-clinical scientists and oncologists in more than 300 hospitals in over 30 countries. It encompasses all aspects of cancer research, from translational research and new drug development to large phase III clinical trials and meta-analyses.

The 170 members of the EORTC Headquarters staff handle some 6.000 new patients enrolled each year in cancer clinical trials, approximately 30 protocols that are permanently open to patient entry, over 50.000 patients who are in follow-up, and a database of more than 180.000 patients.

The ultimate goal of the EORTC is to improve the future of cancer therapy by developing new agents and innovative approaches and to test more effective treatment strategies using commercially available drugs, or surgery and radiotherapy.

http://www.eortc.org/

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