Saturday, November 7, 2015

Submission standards and monopolies

This morning and the last week was frustrating in one aspect. I had to retrieve some personal information from the Austrian tax portal "Finanzonline". It came to mind as I received a letter from the authorities that I hadn't reacted to a message to me on that portal (I didn't even know that there was such a message, as there never has been any E-mail notification). Now I had to reset my password for some reasons, so I tried and expected to obtain an E-mail allowing to do the final step. Instead I got the message that another paper letter would be send to me. I wasn't at home when the postman wanted to deliver it, so I had to pick it up at the post office: the postman was not allowed to throw it in my post box (as it was "official"). To my surprise I did not get a new password - I got two.
It then took me another 15 minutes to get the portal entry working, among others as it wanted me to change these two passwords and required me to enter additional information, i.e. my social security number which is known to them (beyond username and the two passwords). Finally I got into the portal, read the message, saying I needed to provide a few documents. I looked for a PDF upload button. There wasn't. I looked for an e-mail address (including in the letters I got) where I could send the PDFs to. There wasn't either. The only thing I found was a phone number: if I had questions I would need to use that (phone is much more secure than E-mail isn't it? Just ask Mrs Merkel, Germany's chancellor). Essentially, I experienced the portal as one of the top 3 most user-unfriendly systems I ever used (the two others are the German tax portal, which is even worse, and the SAP portal at our university)

So it came as a surprise when a colleague told me that this tax portal is a prize winning portal! I googled somewhat and found the following announcement on the portal's website itself:

Even if your German is good (mine is), can you read it? I can't - they even did not get the encoding of German characters right ... If you would get such a product description on Amazon, would you still buy from them? Looks like a prize winner in the land of the half blind...

Now, what does this have to do with SDTM submission standards?

Just like the tax authorities here, the regulatory authorities for new medications and therapies have a monopoly. They do not need to compete like the Chicago Scubs in basebal (see Wayne's blog). So there is no real drive for IT innovation, except sometimes from the general public over the parliament (see e.g. the article in Medpage Today).

I my not so short life, I have always been one of the first trying out new IT systems when they became available that aimed to make people's life easier. I started using the internet at the time you still needed a phone modem, and transferring a 10MB dataset took a whole day. I started using internet banking at the time that less of 1% of the customers of my bank did. So I gained quite some experience. My experience with IT systems of organizations that have a monopoly is the following:
  • They haven't got a working portal for their "customers" (example: "Deutsche Rentenversicherung")
  • If they have, it is often extremely user-unfriendly (example: the Austrian tax portal)
  • Within the organization, they use outdated technology
  • They generally distrust e-mail 
  • No publicly described web services are available
  • They have no idea what XML and JSON is, or have prejudices against them
Recognize some things in the scope of SDTM and ADaM submissions?

Suppose these type of organizations each have a large set of web services for which the API is publicly available. Then vendors could compete on tools for interacting with the systems of these organizations. For example for the Austrian tax authorities, Austrian citizens could then choose between different portals for communicating with the authorities, the portals being owned by different companies or organizations, competing against each other in user friendlyness.

But this doesn't solve the problem of the drive to modernize...

Any exceptions on these? Just let us know...

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