[R] R Software Risk Analysis

Helmut Schütz he|mut@@chuetz @end|ng |rom beb@c@@t
Fri Jun 19 17:31:29 CEST 2020

Dear all,

any (!) software used in regulated environments has to be validated. 
Regrettably is is a misconception by many working in the pharmaceutical 
industry that only studies evaluated by SAS are accepted by the FDA.
See this one-pager https://www.fda.gov/media/109552/download and a 
presentation by the FDA's Paul Schuette at the useR! 2016 
Note that the FDA itself uses R in modeling & simulation.

Contrary to proprietary (off-the-shelf, commercial, you name it) 
software – where only a black box validation (aka, rubbish in, rubbish 
out) is possible – open source SW allows – in principle – a white box 
validation is possible.

Relying on proprietary SW is not necessarily a good idea ("We payed a 
lot, hence, it will work.") Stephen Senn once told me (given, a good 
while ago) that after an update of SAS, the Welch-test for unequal group 
sizes / variances collapsed into the simple t-test. He called up SAS and 
got the coder on the line. He inspected the source and after a couple of 
minutes replied "Hey, you are right. We screwed up." It took SAS half a 
year to roll out a corrective patch. What about clinicial studies 
evaluated in the meantime?

We published a couple of papers in a specific field comparing software 
(doi:10.1208/s12248-014-9661-0, doi:10.1208/s12248-014-9704-6, 
doi:10.1208/s12248-020-0427-6). It turned out that one of the commercial 
[sic] SWs tested was seriously flawed. Consequences: Dozens of approved 
drugs taken off the market. The glitch in the software was _partly_ 
corrected in 2014 and the vendor stopped marketing it in 2019.

Just by two cents

Ing. Helmut Schütz
BEBAC – Consultancy Services for
Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna, Austria
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