Comments on: FDA To Issue Guidance On Side Effects In Trials http://www.pharmalot.com/2008/05/fda-to-issue-guidance-on-side-effects-in-trials/ News, Comment and Conversation Fri, 10 Feb 2012 20:57:37 +0000 http://wordpress.org/?v=2.6.2 By: Just A Thought http://www.pharmalot.com/2008/05/fda-to-issue-guidance-on-side-effects-in-trials/#comment-356589 Just A Thought Tue, 13 May 2008 05:28:35 +0000 http://www.pharmalot.com/?p=13569#comment-356589 I particularly enjoyed page 6. http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0106-gdl0001.pdf It's not an adverse event! ("It's not a tumah" ~Arnold) If it is an unanticipated problem then it is not an adverse event. Oh really now, it feels pretty dang adverse to me. I don't care if you anticipated it or not. Oh wait, no, it's better to have the unanticipated kind... nope, no adversion here, I'd like my reaction reported now please. This explains so much. I particularly enjoyed page 6.
http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0106-gdl0001.pdf

It’s not an adverse event!
(”It’s not a tumah” ~Arnold)

If it is an unanticipated problem then it is not an adverse event.
Oh really now, it feels pretty dang adverse to me. I don’t care if you anticipated it or not. Oh wait, no, it’s better to have the unanticipated kind… nope, no adversion here, I’d like my reaction reported now please.

This explains so much.

]]> By: ol cranky http://www.pharmalot.com/2008/05/fda-to-issue-guidance-on-side-effects-in-trials/#comment-356558 ol cranky Mon, 12 May 2008 20:59:59 +0000 http://www.pharmalot.com/?p=13569#comment-356558 The biggest problem I've encountered with the reporting of AEs in trials are investigators who only want to record those <i>they</i> think are related to the study drug on the Case Report Forms. I can't tell you how many times I reiterated regulations and protocol requirements about documenting AEs in the source document and CRFs to site staff. Another problem with the reporting of AEs is the lack of follow up by site staff during studies when subjects aren't sewn weekly. It's amazing how many subjects with class IV CHF didn't suffer so much as a common cold during years of follow-up in clinical trials. . . The biggest problem I’ve encountered with the reporting of AEs in trials are investigators who only want to record those they think are related to the study drug on the Case Report Forms. I can’t tell you how many times I reiterated regulations and protocol requirements about documenting AEs in the source document and CRFs to site staff.

Another problem with the reporting of AEs is the lack of follow up by site staff during studies when subjects aren’t sewn weekly. It’s amazing how many subjects with class IV CHF didn’t suffer so much as a common cold during years of follow-up in clinical trials. . .

]]>