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.] Additional projects through which CDISC feels it is adding value for its members were presented. For example, the CDISC Protocol Representation team is developing an open template/tool for its protocol representation standard to enable re-use of information from protocol through reporting. The CDISC XML team has just augmented ODM with an extension for Study Design. And, CDISC is using the study design model in a research grant (HHS/ONC Strategic Health IT and Research Project – SHARP) to research how to potentially program EHRs to identify eligible patients, schedule patients for studies and create data collection forms (eCRFs) for study design. This work, through the CDISC Healthcare Link, fits nicely with the vision of a learning healthcare system where research results can inform clinical care in a timeframe shorter than the 17 years it is purported to take today. The new Time magazine has a cover that alerts us all that our data are being collected and analyzed everywhere (e.g. grocery stores, Facebook)---so we need to accept that (or ‘get over it’). In the clinical research arena, it is important for us to uphold the agreement we make with patients, who agree to provide their data for research and use that data wisely. By providing data standards, CDISC enables the ready sharing and aggregation of information to ensure that we can use information for the benefit of patients. We are all patients. This session closed with a request for attendees (or any of you who read our blogs) to give us feedback on what is most valuable about CDISC to its users and where CDISC can provide more value to its stakeholders.
Share this on