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Today, it is commonplace to see the acronym CDISC projected onto pharmaceutical sector meeting room walls. The Clinical Data Interchange Standards Consortium has developed a set of standards that “support the acquisition, exchange, submission and archive of clinical research data and metadata”. This support was exactly what the industry needed and CDISC standards, with acronyms such as CDASH, SDTM and ADaM, and their implementation is something that most companies have high on their project priority list.
Although the standards themselves come for free, the implementation of them does not. Rather, substantial time and effort need to be invested before the real benefits can be seen. This initial investment can involve reallocation and training of resources, changing of internal standards, reengineering of processes and systems and, in most cases, some outsourcing to companies specialising in these standards. By using SAS software at key points in the data handling and reporting process, you can reduce the initial costs required to implement these standards and achieve their full benefits.
A LITTLE ABOUT CDISC STANDARDS
The most developed and widely implemented of the CDISC standards is the study data tabulation model (SDTM), partly because the FDA in the US recommends SDTM as the model for submission of raw clinical data. The model is not only useful for submission, but also serves as an excellent standard for the interchange of raw clinical data. Due to this, many companies have adopted SDTM as an internal standard for pre-analysis clinical data.
For statistical analysis data, CDISC provides the ADaM model. It supports the clear and unambiguous communication of statistical results, covering both the derived and statistical data as well as result metadata. The FDA does not yet recommend or require the submission of analysis data in CDISC ADaM format, however, due to the strong links between ADaM and SDTM, using them together for a submission increases transparency, which may make this the logical next step. Several companies have already started submitting analysis data in the ADaM format. |
