What is CDISC and Why Does It Matter?
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CDISC and Its Mission
CDISC, the Clinical Data Interchange Standards Consortium, is a non-profit organization whose mission is to increase the impact of clinical research through establishing and promoting the use of data standards for clinical data collection, analysis, and transmission. CDISC develops these data standards in collaboration with global experts through an extensive consensus-based process to ensure that they accurately reflect the research community’s needs and practices.
Who Belongs to CDISC and Why?
CDISC’s membership includes a wide range of groups associated with clinical research, such as:
- Pharmaceutical companies
- Clinical research organizations
- Technology service providers
- Biotech firms
- Academic institutions
- Healthcare providers
- Government agencies
- Non-profit organizations
These members are all interested in maximizing the impact of clinical research data. CDISC data standards help by making clinical data easier to understand and interpret.
In addition to supporting CDISC’s mission, there are benefits to being a member of CDISC, including access to a variety of tools, workshops, and training courses designed to assist clinical researchers better understand and implement CDISC’s data management standards.
CDISC is Important to Everyone Involved with Clinical Trials
Using CDISC standards for data management is important because a person who wasn’t involved in your clinical trial is able to understand the results, as they will be recorded using an established set of abbreviations, codes, etc.
For example, one research group may score the adverse events severity on a scale of 1-5, whereas another group studying a similar population could score severity as being mild, moderate, or severe, which is the CDISC standard. If both studies would record these data using CDISC standards then the results from the first study can easily be compared to the results from the second study, to get a clear picture of the degree of adverse event severity experienced by all the patients involved in both studies.
Similarly, archiving data using CDISC data standards allows other research groups to extract data from existing datasets and analyze them in new ways, as there is no need to first ‘decode’ results that were recorded in an unusual or study-specific way. Many use cases show how existing databases have been used in just this way. Indeed, as former FDA commissioner Robert Califf is referenced as saying, using data standards can increase the amount of useful clinical data that you can derive from a single study, thereby helping to maximize the impact of clinical studies.
In addition, designing a study based on CDISC data standards can enhance the interoperability of clinical research database systems by ensuring that clinical data are recorded the same way in each system. This means that, when the time comes to put all of your data together, patient results recorded in a variety of systems should integrate seamlessly, reducing the amount of time needed for data management and giving you more time to focus on the analysis.
As the CDISC tagline – ‘Clear Data. Clear Impact.’ – highlights, CDISC is important to everyone involved in clinical research trials, because it helps you get as much impact and value out of the data as possible.
How CDISC Standards can be Applied to Clinical Trials
As a review of ODM literature pointed out, CDISC’s Operational Data Management (ODM) standard was ‘created specifically to support the needs of clinical research’. CDISC originally designed this system to facilitate a number of aspects of clinical data management, from data submission to data interchange; and since they were first introduced, CDISC data standards have come to be used at all phases of the clinical research study lifecycle, from health record data management to data archiving.
In addition, as of the end of 2016, the Food and Drug Administration requires all new applications to submit their clinical trial data in Study Data Tabulation Model (SDTM), the standardized format defined by the CDISC, so it is important for clinical researchers to integrate these data standards into their study at the beginning of the planning process.
As of right now there are no set requirements for the European Medicines Agency (EMA), but the Pharmaceutical and Medical Device Agency (PMDA) in Japan has made CDISC a requirement, suggesting that, in the future, the use of CDISC will continue to grow.