Saturday, December 10, 2011

What is CDISC end-to-end?

If we want to discuss something, we first need to define what we are discussing about.

CDISC end-to-end is an already old idea to use a single transport format from clinical research protocol design to submission to the authorities (especially the FDA).
It is however also the idea of re-using information from (earlier) electronic submissions to the FDA for the design or setup of new or follow-up clinical studies.

Until now, CDISC end-to-end was mostly realized and implemented using the CDISC ODM standard and its extensions, such as SDM-XML (Study Design Model in XML) and define.xml (officially "Case Report Tabulations Data Definition Standard").

The next step would be to also develop an ODM-based transport format for submitting the (SDTM/SEND/ADaM) data to the FDA.
The advantages would be tremendous:
  • get rid of the ancient SAS XPT format which has huge disadvantages
  • vendor neutral (SAS XPT isn't)
  • fits seamless with define.xml
  • can be inspected (by use of a stylesheet) in a browser - no further tools necessary
  • stylesheet can mark inconsistencies in the data and violations of the SDTM/SEND/standard
  • reduced file size relative to SAS XPT (the FDA currently has enormous problems opening large SAS XPT files)
  • extremely easy to feed to a database or data warehouse
  • analysis tools can easily be generated as it is all XML
  • and many many more ...
There are however people in CDISC and the FDA that do not want such an end-to-end format, and especially not for the "last mile" to the FDA. They argue that submission data is "something totally different".
In my opinion however, submission data is also clinical data, even when it contains some derived data and has been "categorized" into "SDTM drawers".

1 comment:

  1. Interesting analysis of FDA point of view