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As IRBs move to improve the quality of human subjects protection in international research, they should pursue a model of informed consent that begins long before an individual signs a consent document and continues afterward.
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Public trust in clinical trial research was damaged in the past year because of conflicts of interest issues that arose with the NIH and by front-page media reports about drugs that had been studied and approved, yet were found later to result in deaths among some people who used them.
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Obtaining informed consent from people with schizophrenia is a process fraught with difficulty, as the condition can impair a potential research subjects ability to recall the consent information he or she is given.
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Research into the intricacies of the human genome has opened up a new era for biologic and biomedical research. Investigators are poised to explore the almost unlimited potential to diagnose, treat and possibly cure and prevent many diseases once thought untreatable.
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What is the FDAs most important focus these days with regard to the clinical trial industry?
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Recurrent MI a major cause of death in post MI left-ventricular
dysfunction patients.
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Body size is not a significant predictor of CABG mortality.
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Based on a large national database of heart valve patients, a risk score has been developed to predict operative mortality for any valve surgery.
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Asymptomatic atrial fibrillation occurs commonly after radiofrequency ablation procedures for atrial fibrillation. Thus, a symptom only based follow-up substantially overestimates the true success rate of AF ablation procedures.
