The Problem With Stopping Clinical Trials Early
3 CommentsBy Ed Silverman // October 25th, 2010 // 8:36 am
Two years ago, AstraZeneca halted a trial called Jupiter because its Crestor cholesterol pill outperformed a placebo. The study was undertaken to determine whether Crestor would reduce heart attacks and other cardiovascular problems in patients with no signs of pre-existing cardiovascular disease and low to normal LDL, but elevated levels of CRP, a market linked to heart attack risk (back story).
In doing so, however, the stoppage helped fuel a debate about the vagaries of halting trials before their time. In this video, Gordon Guyatt, an epidemiologist, biostatistician and professor of medicine at McMaster University discusses concerns that stopping trials early is done so to inflate efficacy and the implications of the Jupiter trial. This first appeared on Currrent Medicine TV.
There is a greater awareness of the problems of stopping trials early and “overestimates of the treatment effect that are widely disseiminated…and as a result of that wide dissemination and overestimates, people will be making mistaken decisions when they judge the benefits and potential harm or undesirable consequences of the intervention,” he says.
EddieVos
They stopped that trial without the pre-set # of endpoints .. and the endpoints that were recorded were in MAJORITY medical decisions NOT saving lives and NOT true disease endpoints. No mortality benefit from CV disease! Oh, the wonders of stopping trials early.
http://www.health-heart.org/CRESTOR-rosuva_JUPITER-in-perspective.gif
For the full statin story, see here http://www.health-heart.org/cholesterol.htm
One more pharma scandal.
industry insider
I agree with Eddie. This JAMA paper indicates that interim analyses in RCT’s grossly over-inflate beneficial treatment effects compared to fixed sample size-fixed duration trials. Thus, such studies should not be relied on in my estimation to compare relative benefit/risk because of the exaggerated treatment effect produced by the early stopping.
http://jama.ama-assn.org/cgi/content/full/303/12/1180
RogerSchumann
I recently was given a copy of uaw News and Views for local 969 in Columbus Ohio, this fella who is called a benefit rep is Dale Markovich phone 866-374-4621 or 330-609-8405 is announcing that Nexium has been taken off the market, in the October and November issue of the paper. I was given this issue by one of my older neighbors that is retired from GM. I checked on the astrazenica’s web site and there is no such recall. Some one should be aware of the problem uaw is haveing . They have taken nexium off the formulary, just because they do not want to pay for it does it give them the right to scare uaw members into not taking the medicaiton the dr had prescribed to them? Someone need to get this business rep under control. The article did say Teva has the right to put a generic on the market in 2014 but Nexium is still on the market.