topic Re: how to create efficacy and safety tables in sas? in SAS Health and Life Sciences

how to create efficacy and safety tables in sas?

deleted_user — Thu, 03 Dec 2009 14:58:01 GMT

please tell me in technical terms how to create efficacy and safety tables? Message was edited by: poo29

Re: how to create efficacy and safety tables in sas?

sbb — Thu, 03 Dec 2009 15:18:24 GMT

Suggest you search the SAS support http://support.sas.com/ website either using the SEARCH facility at the site or using, for example, the Google advanced search argument below:

create efficacy safety tables site:sas.com

Scott Barry
SBBWorks, Inc.

Re: how to create efficacy and safety tables in sas?

Flip — Thu, 03 Dec 2009 15:18:51 GMT

I once led a multinational team for 14 months to answer that question just for safety.

Oops .... pasting 4000 pages of documentation didn't work.

Re: how to create efficacy and safety tables in sas?

Doc_Duke — Thu, 03 Dec 2009 15:30:23 GMT

Check out Jack Shostak's book, "SAS Programming for the Pharmaceutical Industry"

Re: how to create efficacy and safety tables in sas?

deleted_user — Thu, 03 Dec 2009 16:10:30 GMT

i have already read that book but no luck in finding this answer

Re: how to create efficacy and safety tables in sas?

Cynthia_sas — Thu, 03 Dec 2009 23:11:39 GMT

Hi:
At a very -basic- level, my Pharma students tell me that they use the following methods to produce the tables and graphs they need for clinical trial reporting:
--PROC REPORT
--PROC TABULATE
--SAS/GRAPH with ANNOTATE
--ODS GRAPHICS with Statistical Procedures
--SAS/GRAPH SG Procedures
--SAS Macro Programs

The key thing is getting the data organized appropriately, in the required form and structure required by the FDA. If you look at the PharmaSUG and other user-group papers, which are archived at:
http://www.lexjansen.com, you will find quite a few hits, these among them.
http://www.lexjansen.com/phuse/2008/ad/ad12.pdf
http://www.lexjansen.com/pharmasug/2007/tt/tt14.pdf
http://www2.sas.com/proceedings/sugi22/TRAINING/PAPER320.PDF
http://www.nesug.org/Proceedings/nesug06/po/po23.pdf
http://www2.sas.com/proceedings/sugi26/p129-26.pdf
http://www.lexjansen.com/pharmasug/2009/sa/sa-ad-02.pdf

For more information about the FDA requirements, you should look at the FDA site. In addition, if you work for a Pharmaceutical company or a CRO, it is my experience that every company has their own procedure for validating code logic and producing reports. Some companies produce tables with DATA _NULL_ and LISTING output and have a group create the RTF or PDF files required by the FDA. Some companies use ODS RTF or ODS PDF.

As previously explained the standards are voluminous and the implementation of the standards is equally voluminous.

cynthia