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The recent lawsuit against Abiomed Inc. of Danvers, MA, and others involved in clinical trials involving the AbioCor Implantable Replacement Heart shows that sometimes the best preparation and informed consent process still cannot prevent litigation.
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No investigator or coordinator wants to believe it could happen. But in clinical trials, injuries or adverse events are always a possibility. The question for many is, What will happen to study subjects who are injured in the course of their research participation?
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All AEs will be assessed by the investigator using the protocol-defined grading system. If the protocol has no defined grading system, or if the AE is not described in the existing grading system, the following guidelines should be used to qualify severity.
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By calling an 800 number and paying a $5 fee, residents in four Wyoming cities can have face-to-face consultations with clinical pharmacists, who not only review the residents health and medication history but make cost-saving suggestions as well.
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The following drugs are in various stages of clinical studies and trials.
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Palonosetron, developed by MGI Pharma and its partner Helsinn Healthcare SA, is a recently approved selective antagonist of serotonin subtype 3 receptors (5-HT3).
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These drugs recently received final approval from the U.S. Food and Drug Administration (FDA).
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This study reports the association between inflammation as measured by C-reactive protein and the prevalence and development of atrial fibrillation.
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In this paper, Grimm and colleagues report on the usefulness of noninvasive testing to predict risk for arrhythmias in patients with idiopathic dilated cardiomyopathy.
