Thursday, September 15, 2016

FDA and SAS Transport 5 - survey results

As promised on LinkedIn, I analyzed the results of the survey where people were asked the question "In my opinion, the FDA should ..." with the following possible answers:
  • Continue requiring SAS-Transport-5 (XPT) as the transport format 
  • Move to XML (e.g. CDISC Dataset-XML) as soon as possible
  • Move to RDF as soon as possible
  • Other 
People were also asked who they are working for: Pharma Sponsor,  CRO, Service Provider, Software Company, or Other.
We had 57 answers (which is considerably less than I had hoped for). Here are the first results:

with a relative good distribution between all groups (some ticked more than 1 box), with a slight overrepresentation of pharma sponsors (which isn't a surprise as they do the FDA submissions).

And here come the results about the question on the exchange format:

Over 50% voted for moving to an XML-based format like CDISC-Dataset-XML, about 25% for moving to RDF. A minority of less than 20% voted for continuation of the current FDA policy to require SAS Transport 5.

I tried to make a detailed analysis looking for relations between the answer about the preferred format and the company type, but didn't find any. The only slight trends I could see (but statistically not significant at all) is that RDF is a bit overrepresented in the "Sponsor" group, and that "SAS-Transport-5" is slightly overrepresented in the "CRO" group. Only 3 (out of the 20) "sponsor voters" voted for "Continue requiring SAS-Transport-5".

The survey also allowed to provide comments. Here are the most interesting ones:
  • If it's not broken, don't fix it.  Pharma is a big industry and slow to change/adapt 
  • We must move beyond the restrictive row/column structure
  • SDTM is useless and error prone. We need modern data models and semantics
  • Consider JSON also. Get rid of Supplemental domains
  • Going for RDF means that ADaM, SDTM and the rest could be all linked together ...
If anyone would like to analyze the results in more detail, just mail me and I can send the complete results as a spreadsheet or as CSV or similar.


  1. Thanks Jozef, the PhUSE Alternative Transport group will be releasing their questionnaire imminently. It will make an interesting dataset for sure!

  2. Votes by 54 persons are not statistically relevant info which is also heavily biased by people who actually wants changes

    1. Hi Sergiy,
      Did I ever claim statistical relevancy? I don't think so! And one of the options was indeed "keep requiring SAS-XPT". So your second argument doesn't make sense, as people who do not want any change could also vote (and they did).