[R] SAS or R software
henric.nilsson at statisticon.se
Sat Dec 18 16:24:58 CET 2004
Frank E Harrell Jr said the following on 2004-12-18 15:03:
> That is not clear.
Perhaps. And I think this is the issue. From the clients' perspective,
not a single FDA document states that you can use other software than
SAS. They haven't really thought about the fact that there isn't any FDA
documents encouraging the use of SAS for statistical analyses.
I don't think that the real problem is convincing regulatory authorities
that R (or any other (open-source) software for that matter) is
operating adequately. But clients and auditors seems to reason along the
lines of "rather being safe than sorry" and "nobody's ever been critized
for using SAS". From their perspective, when we propose using `some
other' software they start thinking that it perhaps may jeopardize their
trial results (and, all to often, "but doesn't FDA require SAS?").
How to fight this? I don't know. Right now I'm thinking, "If you can
beat 'em, join 'em" and that the way of proving that `some other'
software works is through having similar documents and tools as the
> And since FDA allows submissions using Excel, with
> not even an audit trail, and with known major statistical computing
> errors in Excel, I am fairly certain that it is not applicable or at the
> least is not enforced in any meaningful way.
The general preconception seems to be that neither SAS nor Excel needs
validation. E.g. the British guideline referenced in my previous email
states on p. 12 that
"It is generally considered that there is no requirement for validation
of commercial hardware and established operating systems or for packages
such as the SAS system, Oracle and MS Excel, as entities in their own
right. However, most are configurable systems and so need adequate
control of installation and their configuration parameters."
Luckily for Excel, not a single word about precision and adequacy...
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