This study is actually the first of four placebo-controlled, Phase III trials to be completed.
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If the drug is approved, it may make it difficult to conduct that placebo-controlled trial.
It was not placebo-controlled, blinded, or randomized, which presents major methodological problems regardless of what happened.
Packer says this is the first placebo-controlled study in acute heart failure to show a clinical benefit.
It is because the government-funded trial was a placebo-controlled, double-blind, randomized controlled trial.
In fact, it was one of the placebo-controlled studies, begun in 1999, that resulted in Vioxx being pulled from the market.
Claire Bombardier, the University of Toronto researcher who had conducted Merck's big ulcer study, criticized the new studies for not being placebo-controlled.
With so much at stake I was surprised that there had been no prospective, placebo-controlled trials conducted that were funded by an independent source.
An analysis of neurological and psychiatric effects in placebo-controlled Chantix studies of 5, 000 patients will be presented at a medical meeting in Rome later this month.
Dr. Hartwell, who wasn't involved in the study, said social-network trials aren't likely to replace conventional randomized, double-blinded, placebo-controlled trials, the gold-standard for generating medical evidence.
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In recent years, two larger placebo-controlled studies have been published.
"We know that it causes problems from placebo-controlled trials, " says Garret FitzGerald, a pharmacologist at the University of Pennsylvania, who predicted early on there might be a risk with Cox-2 drugs.
The randomized, double-blind, placebo-controlled, multi-center trial enrolled 51 patients age 12 to 53 years, including 7 patients age 12 to 16 years, who were maintaining a regimen of maximally-tolerated lipid lowering medications.
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JUPITER, one of the largest trial of statins, with 17, 802 patients, was not published until 2008, nor did we have diabetes data available from many of the other placebo-controlled trials until after 2004.
The safety and efficacy of Belviq were evaluated in three randomized, placebo-controlled trials that included nearly 8, 000 obese and overweight patients, with and without type 2 diabetes, treated for 52 to 104 weeks.
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And in a study published last year, researchers in Australia showed in a double-blind, placebo-controlled trial that subjects with suspected gluten sensitivity had substantially fewer symptoms on a gluten-free diet than control subjects who unknowingly ingested gluten.
Studies that were often double-blind and placebo-controlled.
Safety data for KYNAMRO are based on pooled results from four Phase 3, randomized, double-blind, placebo-controlled trials with a total of 390 patients of which 261 patients received weekly subcutaneous injections of 200 mg of KYNAMRO and 129 patients received placebo for a median treatment duration of 25 weeks.
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Paxil CR and Paxil have not been directly compared with one another, but in studies comparing each to placebo, patients were less likely to stop taking the controlled-release version because of side effects.
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