Effects of FDA guidance going into force in January 2017
In December 2014, the US Food and Drug Administration [FDA] published the guidance on the submission of approval applications in electronic format. According to this guidance, clinical studies with products which are submitted for approval to be sold on the US market shall be conducted on the basis of CDISC beginning in January 2017.
Although the guidance addresses approval for the US market exclusively, it actually affects the outsourcing of studies to clinical contract research organisations worldwide. Because from now on, product and outsourcing managers will always have to decide whether an approval in the lucrative U.S. market is planned, or whether it could at least be a future option.
If at least the option of US approval is being considered, the primary use of CDISC formats is advisable. Otherwise, the data formats would have to be subsequently converted to the CDISC standards in case of an actual expansion to the US market. Therefore, proDERM is naturally offering the evaluation of studies in CDISC format as well.
CDISC is a data standard accepted in clinical research which regulates, among other things, the content structure of tables (SDTM = Study Data Tabulation Model) as well as the documentation of statistical methods for the analysis (ADaM = Analysis Dataset Model).