Comments on: Few Pediatric Trials Had Safety Monitoring: Study http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/ News, Comment and Conversation Fri, 10 Feb 2012 21:10:08 +0000 http://wordpress.org/?v=2.6.2 By: Gary Pitt http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-218499 Gary Pitt Thu, 20 Mar 2008 19:16:29 +0000 http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-218499 Ed- I'm impressed with your follow-up. Thanks! Ed- I’m impressed with your follow-up. Thanks!

]]> By: Ed Silverman http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-218043 Ed Silverman Thu, 20 Mar 2008 16:06:09 +0000 http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-218043 To Gary Pitt, Outside the Box and Jack2, The lead author has replied to your questions. Please scroll to the bottom of the post to read her answers. Regards ed To Gary Pitt, Outside the Box and Jack2,

The lead author has replied to your questions. Please scroll to the bottom of the post to read her answers.

Regards
ed

]]> By: Ed Silverman http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-217854 Ed Silverman Thu, 20 Mar 2008 13:00:37 +0000 http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-217854 Jack2, Gary Pitt and Outside, I've just included links to the study and some tables. I'm still waiting for the lead author to reply to my note. Regards ed Jack2, Gary Pitt and Outside,

I’ve just included links to the study and some tables. I’m still waiting for the lead author to reply to my note.

Regards
ed

]]> By: Lisa Van S http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-216880 Lisa Van S Wed, 19 Mar 2008 20:47:24 +0000 http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-216880 Jack2 Unfortunately, Im not making anything up, personal experience! May I direct you to the Starledger's online edition. On the left hand side you will see links to NJ's UMDNJ Scandal. You can also google Dr. Marie Carmen Palazzo! Jack2

Unfortunately, Im not making anything up, personal experience! May I direct you to the Starledger’s online edition. On the left hand side you will see links to NJ’s UMDNJ Scandal. You can also google Dr. Marie Carmen Palazzo!

]]> By: Ed Silverman http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-216831 Ed Silverman Wed, 19 Mar 2008 19:43:32 +0000 http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-216831 Dear Jack2, Gary and Outside, I have asked the lead author to answer your questions. Hopefully, she will reply, and either write to me directly, in which case I will post her answers and alert you to their existence, or she post them here herself. You've asked good questions and, since I've not spoken with her and also don't have access to the complete study, I'm curious to learn what she has to say. Thanks for writing in, Cheers ed Dear Jack2, Gary and Outside,

I have asked the lead author to answer your questions. Hopefully, she will reply, and either write to me directly, in which case I will post her answers and alert you to their existence, or she post them here herself.

You’ve asked good questions and, since I’ve not spoken with her and also don’t have access to the complete study, I’m curious to learn what she has to say.

Thanks for writing in,
Cheers
ed

]]> By: Outside the Box http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-216814 Outside the Box Wed, 19 Mar 2008 19:20:41 +0000 http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-216814 What proportion of the trials for these drugs in adults used an independent safety monitoring committee? Is there clear evidence to show that the absence of a safety monitoring committee resulted in a higher rate of safety related events in these trials? In other words, to what extent is this a real concern that trials in children were less well monitored, and as a result less safe, than was the case for the same products when tested on adults? What proportion of the trials for these drugs in adults used an independent safety monitoring committee? Is there clear evidence to show that the absence of a safety monitoring committee resulted in a higher rate of safety related events in these trials?

In other words, to what extent is this a real concern that trials in children were less well monitored, and as a result less safe, than was the case for the same products when tested on adults?

]]> By: Gary Pitt http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-216805 Gary Pitt Wed, 19 Mar 2008 19:15:38 +0000 http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-216805 Good point Jack2 - Ed, is this something you might be able to share? Good point Jack2 - Ed, is this something you might be able to share?

]]> By: Jack2 http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-216761 Jack2 Wed, 19 Mar 2008 18:04:54 +0000 http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-216761 So now you're just making stuff up Lisa? Ed: Any indication in the article about the %'s by trial-type for industry run trials (A), industry-sponsored investigator-initiated trials (B), and government-sponsored trials (C)? I can't read the whole article. If I may make stuff up: we would find the highest percents in group A, and the lowest in group C. What's your take on this ol'cranky? So now you’re just making stuff up Lisa?

Ed: Any indication in the article about the %’s by trial-type for industry run trials (A), industry-sponsored investigator-initiated trials (B), and government-sponsored trials (C)? I can’t read the whole article. If I may make stuff up: we would find the highest percents in group A, and the lowest in group C.

What’s your take on this ol’cranky?

]]> By: Dan http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-216750 Dan Wed, 19 Mar 2008 17:50:05 +0000 http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-216750 Many peds trials are performed to extend the patent of already marketed drugs primarily to adults. Many peds trials are performed to extend the patent of already marketed drugs primarily to adults.

]]> By: Lisa Van S http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-216746 Lisa Van S Wed, 19 Mar 2008 17:40:05 +0000 http://www.pharmalot.com/2008/03/few-pediatric-trials-had-safety-monitoring-study/#comment-216746 This is pretty frightening!!!. Im sure the clinical trials of antipsychotics in children went unmonitored. This is pretty frightening!!!. Im sure the clinical trials of antipsychotics in children went unmonitored.

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