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 ...
In my opinion however, submission data is also clinical data, even when it contains some derived data and has been "categorized" into "SDTM drawers".