tpr.org

[desrt]

Interesting segment on the Texas Public Radio show 'Texas Matters' this morning. Tuned in in the middle of the show which was primarily focused on primate testing of pharmaceuticals. They were using the example of HCV drugs and cardiotoxicity which only showed up during primate testing run in parallel to human testing. I assume they were referring to the protease inhibitor BILN 2061 which a few years ago showed as much promise as tele' or boce' but trials were stopped in the middle of phase 3 due to cardiotoxicity.

[desrt]

Went back, found the link, and listened to the entire segment:
http://tpr.org/programs/texasmatters.html
show #545 segment 6
mostly about animal rights and a primate testing lab in San Antonio - 6.5 minutes and very little about HCV in it.

My concern is that with the pressure to 'fast track' new drugs, are corners being cut to bring new products to market? This link I posted a couple months ago about 'black box' warnings added *after* FDA approval and the fact that many docs Rx based on the original trial data gives another prespective.
http://www.msnbc.msn.com/id/40536739/ns/health-cancer/

[Trish77]

Some brief information on success rates for drugs entering clinical trials.  Noted that it's becoming harder to get a drug to Phase III. My trial drug was dropped in Phase 2b, showed great promise up until then.  

http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/Data+Analysis/Drug-Success-Rates-Remain-Low/ArticleStandard/Article/detail/666790

It now costs more than $1 billion and takes more than seven years, on average, to conduct clinical trials and win regulatory approval to market a new drug. Not only are development costs high and rising steadily, but also only one out of every six self-originated drugs developed successfully completes clinical testing and obtains marketing approval.
This 16% overall success rate—gleaned from the portfolios of the top 50 largest global pharmaceutical companies—has remained relatively constant despite efforts on the part of sponsors to improve the overall quality, predictability, and scope of their clinical research data. Although overall success rates have not changed substantially during the past decade, some trends in phase transition probabilities have been observed: Clinical transition probabilities between Phase i and Phase II and between Phase II and Phase III have gotten lower, suggesting that drug sponsors are becoming more aggressive about terminating unpromising candidates, enabling them to redirect increasingly scarce R&D resources to more promising drug development programs.—Tufts Center for Drug Development, http://csdd.tufts.edu|~http://csdd.tufts.edu/ .

[nygirl7]

And there is the reason they do trials - and we wait and wait and wait for approval on SOMETHING!!!!!!