As a result, I suspected that bapineuzumab would fail to show any meaningful clinical benefit.
Packer says this is the first placebo-controlled study in acute heart failure to show a clinical benefit.
The FDA gave the drug accelerated approval, and Pfizer is conducting post-marketing clinical trials to further evaluate its clinical benefit.
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Although niacin, a natural vitamin, has been used for decades to raise HDL, a clinical benefit has never been demonstrated.
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The first such drug, Mylotarg, was recently withdrawn from the market after it failed to show a clinical benefit in studies.
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HPS2-THRIVE was designed to answer criticism from the FDA and other experts about the lack of any evidence demonstrating clinical benefit.
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The largest-ever study of niacin has failed to show a clinical benefit for niacin and even found a strong signal of harm.
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Under these regulations, the manufacturer must conduct additional studies after the product is approved to demonstrate that the drug does, in fact, have a clinical benefit.
People with HIV often remain asymptomatic for years, and conventional wisdom is that treating such people brings little clinical benefit while exposing them to unpleasant side effects such as nausea, vomiting and diarrhoea.
Although it had been the subject of earlier questions, serious criticism emerged with the publication in 2009 of the TREAT trial, which found no clinical benefit for the drug in patients with chronic kidney disease.
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John Kastelein, a cardiologist at the University of Amsterdam who is conducting a separate set of imaging studies of arteries in the neck, says that if torcetrapib removes plaque from the arteries over the course of two years in three different studies, it may still present a very compelling clinical benefit for patients.
Both drugs failed to show a clear survival benefit in clinical trials.
He said there were important clinical implications, as the benefit of the treatment was conferred to the group of patients with the highest risks for cardiovascular events, and the effect persisted, even at a rather late stage of disease.
Such a marker would also benefit the organisers of clinical trials.
But randomized controlled clinical trials also are used to prove benefit in big drug studies.
This is the second time that niacin, long a mainstay of therapy, has failed to benefit patients in a large clinical trial.
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Plus, successful clinical trials of new drugs routinely show a benefit on such metrics over a 1- or 2-year period.
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Pharmaceutical companies, currently hanging off "the patent cliff", could also benefit from sharing the data from clinical trials, he said.
But the AHA fails to note that there have been no big randomized clinical trials with hard outcomes that show the benefit of their diet.
Pharmacia and DeCode will run clinical trials to see if people with these markers benefit from being put on Inspra or other cardiac drugs being developed by Pharmacia.
In Europe, clinical guidelines exist which ensure that only those people who will benefit most are targeted for treatment, and this has led to prescribing levels of between 12% and 16%.
So what we're saying is we should have the clinical freedoms to work with the patients for the patients' benefit to work out who takes priority in a cash limited system and make sure the patient gets the quality service that they need for their complaint - not the one that's politically expedient.
Dr Ellis said the new combination was also likely to benefit all women with early breast cancer - although the clinical trials to confirm that were still ongoing.
The device has still to undergo clinical trials, but if all goes well the first babies to benefit from it will be receiving Dr Ayoub's implants in 2005.
One of the pioneers in this field is Britain's National Institute for Health and Clinical Excellence, which uses large datasets to investigate the cost and benefit of new drugs and existing expensive treatments.
Indeed, the watchdog NICE (National Institute for health and Clinical Excellence) rejected Nexavar for NHS use based on its cost-benefit calculation.
Publishing their results in The Lancet medical journal, the scientific team led by Dr Kristin Newby at the Duke Clinical Research Institute of North Carolina, said sibrafiban "showed no additional benefit over aspirin" in preventing cardiac arrest.
The patients who did benefit from cognitive behavioural therapy spent one hour a week with a clinical psychologist learning skills to help change the way they think.
Clark added the company's Clinical and Medical Products sector will be a key growth driver, and expects to benefit from new generic pharmaceutical launches and improvements in operational performance.
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