| The endorsement of the study data tabulation model (SDTM) by the Food and Drug Administration will encourage many people to adopt CDISC standards. Paul Frost at Oxford Pharmaceutical Sciences examines the importance of external data standards within the pharmaceutical industry
There has been much discussion in recent years surrounding the advantages and disadvantages of external data standards within the pharmaceutical sector. Most of the major pharmaceutical companies have their own standards. For those companies not already adhering to an external standard there may be a reluctance to change. The cost of moving data standards can be high and many companies in the past have felt more comfortable working with a standard they own and can control. This article discusses why companies might want to adopt external standards, if they haven’t already, along with any obvious drawbacks.
When we speak of data standards within the pharmaceutical sector we automatically think of the Clinical Data Interchange Standards Consortium (CDISC). Over the past few years, CDISC has worked to create, publish and maintain a number of data standards. In their own words “CDISC is an open, multidisciplinary, non-profit organisation that has established worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development”. Although there are a number of different standards intended for different purposes, most of this discussion will refer to the study data tabulation model (SDTM). So why would we want to adopt these standards? |
