Link between Clinical Research and SDTM
The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) defines a standard structure for human clinical trial data and for non-clinical study data tabulations that are to be submitted as part of a product application(IND and NDA) to a regulatory authorities such as the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals Medical Devices Agency (PMDA).
Prescription Drug User Fee Act(PDUFA) which governs the requirement for data standards and provides FDA with the necessary resources to maintain a efficient and predictable review process for human drug and biologic products.
Clinical trial data review process has significantly accelerated by SDTM standards by reducing Non-clinial programming(to familiarize data structure, check data accuracy, formats) time upto 70%.
The availability of standard submission data will give many benefits to regulatory reviewers. Reviewers will be trained in the principles of standardised datasets and the use of standard software tools and thus be able to work with the data more effectively with less preparation time.
SDTM can also useful for creating a clinical research data warehouse secondarily to leverage clinical research study data across studies which are conducted within the same therapy area.
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