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Sponsor-investigator-relationship: challenges, recent regulatory developments and future legislative trends 被引量:1
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作者 raphael richard ciuman 《Health》 2011年第12期772-781,共10页
Correct definition and management of sponsor- investigator relationship is of central importance for planing and executing clinical trials. During the last decade, there have been numerous modifications of guidelindes... Correct definition and management of sponsor- investigator relationship is of central importance for planing and executing clinical trials. During the last decade, there have been numerous modifications of guidelindes, international and national legislations and regulations. This implicated various alterations and shifts of essential responsibilities and tasks relating to the investigator, sponsor or sponsor-investigator what raised financial, clinical and ethical issues. First experiences with these new regulations and legislations are discussed together with international differences and their impacts on clinical trials. Regarding non-commercial trials and institutional sponsorship, there are still open organizational and legal questions after national implementation of the Europeam Clinical Trials Directive in 2004, although various approaches have been suggested in recent years in Europe. Current trends and controversies are discussed as well. A literature review was performed summarizing recent experiences with current legislations and risen controversies of these new legislations showing impact on future trends. 展开更多
关键词 INVESTIGATOR SPONSOR CLINICAL TRIAL Non-Commercial TRIAL European CLINICAL Trials Directive CONFLICT of INTEREST
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Morbus Menière: Were the last 50 years of molecular biological research fruitless for Menière's disease?
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作者 raphael richard ciuman 《World Journal of Otorhinolaryngology》 2015年第4期90-92,共3页
After discovering an inner ear hemorrhage, Prosper Menière ascribed disease to the inner ear for the first time. Since that time, a lot of efforts have been made to determine the pathophysiologic causes of the cl... After discovering an inner ear hemorrhage, Prosper Menière ascribed disease to the inner ear for the first time. Since that time, a lot of efforts have been made to determine the pathophysiologic causes of the classical symptoms sensorineural hearing loss, vertigo attacks, tinnitus and ear fullness. According to its express pattern Menière’s disease may appear as classical and atypical disease. In the last decades, huge advances have taken place in biochemical and physiological research and in pathophysiological understanding of the inner ear and its diseases. This encloses stimulus perception and conduction, regulation of inner-ear fuid homeostasis and inner ear diseases with underlying genetics. Menière’s disease pathophysiologic correlate is an endolymphatic hydrops which is characterized by changes of inner ear homeostasis with its parameters volume, concentration, osmolarity and pressure of the endolymph. Hormones, autonomous system and the immunsystem together with purinergic, adrenergic and muscarinic receptors, steroids, vasopressin, atrial natriuretic peptide and aquaporin channels regulate inner ear homeostasis. Consequently, general diagno-stics comprise a magnetic resonance imaging with gadolinium, vestibular diagnostics and tone audiometry. Standard therapy for acute inner ear symptoms is limited to cortisone infusions together with a rheologic agent or a radical scavenger. For acute vertigo attacks and for the mainstay therapy antivertiginous pharmaceuticals are given. In severe cases destruction of the vestibular hair cells by ototoxic antibiotics, endolymphatic sac surgery or neurectomy of the vestibular nerve might be necessary. Certainly, in research there is a move from simple pharmaceutical therapy forward to nanoparticle-based, genetic-based and stem cell therapy. 展开更多
关键词 Menière Hearing loss VERTIGO TINNITUS Endolymphatic hydrops Stem cell Genetic-therapy Nanoparticles
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