Ugeskrift for laeger
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Ugeskrift for laeger · Apr 2003
[New drugs and European procedures of approval. The European Agency for the Evaluation of Medicinal Products' role].
Whereas regulatory drug approval in Europe previously was the responsibility of national authorities, innovative new drugs are now being approved by the European Commission instead. Through its agency for drug evaluation (EMEA), the Commission provides guidance on the clinical documentation necessary to obtain regulatory approval for new drugs. As a large proportion of clinical drug trials is sponsored by industry and aims at obtaining regulatory approval, the guidance provided by EMEA will have increasing influence on clinical drug research in Europe.
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Ugeskrift for laeger · Apr 2003
Comparative Study[Does the public sector have an independent research role in the development of drugs?].
Exclusively private companies do drug development. The State contributes with education of academics and basic research constituting the basis of half of the drugs developed by the private companies. ⋯ There are doubts about the scientific credibility, the number of new drugs is declining, drug development costs are rising, and the competitiveness in Europe is declining compared with the one of The United States. Continued improvement of Danish drug development can be achieved by stimulation of the public research related to drug development.
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Since 1992 a law based national system of Scientific Ethical Committees has existed. It consists of regional committees supplemented with a Central Committee. ⋯ A new law in 2003 will implement the EU directive on Good Clinical Practice. A maximum time of 60 days for the approval of biomedical research projects and approval of multi-centre trials at only one scientific ethical committee will be introduced.
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Ugeskrift for laeger · Apr 2003
Review[Troponin elevation--differential diagnostic considerations and prognostic importance].
It has become increasingly evident that elevation of troponins can be demonstrated in other diseases than acute myocardial infarction. In this review we wanted to assess the prevalence and the clinical importance of troponin elevations in patients with mainly extra-cardiac organ manifestations. Only in chronic renal failure there appears to be evidence to support the conclusion that high levels of troponins are associated with an adverse clinical outcome. ⋯ One explanation could be that the patients involved have ischemic heart disease as co-morbidity. Severe stress caused by an acute non-cardiac clinical event may result in a minor leakage of myocardial markers. It is essential to perform a careful clinical evaluation in the case of patients with unexpected high levels of cardiac troponins.