[R] SAS or R software

[Henric Nilsson]

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 
commercial vendors.

>  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...


Henric