A very long list is used in submissions, from simple stats, t-tests, sample size calculations, power analysis, regression, ANOVA, non-parametric techniques (chi square, CMH, etc), monte carlo simulations, survival analysis, etc. This is why there are whole Masters and PhD programs just around Biostats... I left off design for early studies, pharmacoeconomic analysis, etc.
From: email@example.com [mailto:firstname.lastname@example.org]
Sent: Wednesday, August 20, 2008 9:27 AM
To: Stephen McDaniel
Subject: Re: Validating SAS for FDA?
Just what specific statistical function does the clinical pharma
industry use ( eg means ,mode, regression etc)
On 8/20/08, Stephen McDaniel <email@example.com> wrote:
> I remember way back in the late 90's when I worked for Oracle with the
> Oracle Clinical consulting team... This is a product meant for managing
> clinical trials data for pharma's. The main product manual prominently said
> on page one something to the effect, "... not for use in nuclear, aerospace,
> or medical applications..., any use in this realm is explicitly not under
> warranty and Oracle can't be held accountable for the precise standards
> needed for these types of applications..." or something to that effect.
> Clients loved it when I pointed out that their multi-million dollar software
> package stated this in the main manual. Of course, many companies use it
> for submissions. Ultimately, the FDA holds the pharma accountable, not the
> software maker. That said, if they saw consistent problems with an
> application, they might be much harder on any pharma using the app,
> ultimately hurting the software company via lower sales and discount demands
> by the customers.
> On Wed, Aug 20, 2008 at 9:00 AM, Mary <firstname.lastname@example.org> wrote:
>> They might want to change the name...I can't see the FDA as being wild
>> about verifying that software with "BUGS" as part of the name is actually
>> free of bugs!
>> ----- Original Message -----
>> From: Kevin Viel
>> To: SAS-L@LISTSERV.UGA.EDU
>> Sent: Wednesday, August 20, 2008 10:47 AM
>> Subject: Re: Validating SAS for FDA?
>> >For what it's worth, my provisional plan is to demonstrate that
>> >WinBUGS accurately replicates textbook examples, to document this, and
>> >to place the document on file.
>> I am a bit removed from that field, but why turn to textbook examples
>> instead of simulating the data?