CDISC Blog  filter by date: April 2011

Bron Kisler, CDISC VP, Strategic Initiatives, Spoke at the CDISC European Interchange in Brussels

Bron Kisler (CDISC VP, Strategic Initiatives) spoke first at the Thursday (14 April) afternoon joint session of the CDISC European Interchange in Brussels. He emphasized the value for patients in adding standards specific to therapeutic area (efficacy standards) to the base CDISC standards (primarily the safety domains that are relevant to all clinical studies). He spoke of the need for inclusion of clinicians in developing definitions for these standard elements and also the value of having the viewpoint of the regulators who need to review application for new drugs in these areas. Specifically with respect to this latter viewpoint, one of the key benefits of standard cardiovascular elements is to simplify the analysis of events in drug development programs or among various clinical trials to more easily identify trends and other safety signals. CDISC began work on the cardiovascular data elements with Duke on an NIH Roadmap Grant several years ago. To augment this work, Dr. Karen Hicks of FDA initiated an effort that focused on the need for regulators to have standards to facilitate their reviews of new drug applications.

Dr. Ilias Iakovidis was the Keynote Speaker for the CDISC European Interchange

Dr. Ilias Iakovidis was the keynote speaker for the Europe Interchange. He highlighted the work of the European Commission (EC), particularly with respect to eHealth. He spoke of the value of standards for interoperability and information re-use along with the lack of understanding and appreciation of this value in political circles. He encouraged the standards community to get involved at this level and to communicate in a comprehensible manner. He equated our current issues in healthcare to a ‘crisis’ and pointed to innovation as the way out of this crisis mode. He noted two key ‘goldmines’ that have not been appreciated adequately to date: Patients and Information. He also joked that if one cannot solve a problem, one can make it bigger! More seriously, he stated that solving some of the healthcare issues within a given country or even across the European Union did not seem to be working, so he began to work with the U.S. where the same issues exist. We can expect an announcement about the EC working with the U.S. Department of Health and Human Services Office of the National Coordinator (HHS/ONC) through a project called EPSOS to standardize EHR patient summary data for the EU and the US. Eventually, this should support public health research. The re-use of health data for public health, education and research is the goal. In this context, the EC is cooperating with HHS/ONC in two key areas: Interoperability and Exchange of Best Practices.

Dr. Kush Presentation on how CDISC is Striving to Provide Value to its Broad Group of Members

During the CDISC European Interchange in Brussels last week, Dr. Rebecca Kush, President of CDISC, gave a presentation that focused on how CDISC is striving to provide value to its broad group of members. CDISC (unlike most standards organizations) offers its standards openly and freely. Standards development and maintenance, however, has associated costs. To cover these costs, CDISC continues to diversify its revenue streams such that funding now comes from many sources, including grants and contributions, in addition to education and membership. CDISC also has a range of members in various functional areas, which includes not only data managers, statisticians and IT professionals, but also medical writers and program/project managers. One important nuance is that CDISC retains the intellectual property (IP) for the CDISC standards so that it can ensure that they remain open and free. [Note that this is based upon negative experiences of other standards organizations who were hurt by not managing their IP appropriately. In fact, there is a CDISC IP Policy on the website under “About CDISC” –www.cdisc.org.]

CDISC European Interchange, Brussels, Belgium, 13-14 April 2011

The CDISC European Interchange has taken place in the heart of Brussels, thanks to all who attended and made it successful! More than 200 people from all over the world attended this CDISC conference in Brussels, including more than 100 attendees for the training courses on Monday, Tuesday, and Friday. The CDISC Board of Directors also held a productive meeting in Brussels on 11-12 April to discuss CDISC Strategic Aims for the next five years.

Dr. Pierre-Yves Lastic, Chair of the European CDISC Coordinating Committee (E3C), opened the Interchange with a presentation on 10 years of CDISC in Europe. It was great to see the progress CDISC has made in Europe during this past decade. Many thanks for the hard work of the E3C and CDISC Operations.

Stay tuned to the next European Interchange blogs! These will be posted over the next two weeks. And get ready for the upcoming CDISC North America Interchange in Baltimore, MD on October 10 - 14.

Please consider a sponsorship or a booth and send in your abstracts; the deadline for submission is Friday, 6 May, 2011.