Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Jun 2009
[Safety of high risk in vitro diagnostic medical devices : international and national measures].
The European Directive 98/79/EC for in vitro diagnostic medical devices (IVD) [1] regulates the marketing and post marketing surveillance of IVD in the European Union. In accordance with this regulation, those legally responsible for the IVD product have to report all incidents and corrective measures with IVD to the national competent authority. In Germany, these are the Federal Institute for Drugs and Medical Devices (BfArM) and for high risk products, as specified in Annex II of the Directive 98/79/EC, the Paul Ehrlich Institute (PEI). ⋯ The reporting ratio of the IVD users amounted to 8.5%; in 12 cases (7.1%) PEI was informed via Vigilance Reports from other European competent authorities concerning incidents and recalls with IVD. The experience from 6 years' IVD surveillance showed that the German market surveillance system ensures a high level of safety concerning the in vitro diagnostic medical devices of Annex II list A and B of Directive 98/79/EC. However, the current system can be further optimized.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Apr 2009
[The authorization of clinical trials by the federal authorities].
Since 2004, clinical trials of medicinal products have to be approved by the federal authorities in Germany. Authorization is necessary in addition to the favorable opinion of the concerned ethics committee. ⋯ However, the implementation of Good Clinical Practice has also increased both safety for the trial subjects and validity of the data. The most important laws and regulations, definitions, the procedures for submitting a clinical trial application as well as subsequent amendments are described and further information is provided.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Apr 2009
[Clinical trials beyond the German Drug Law. Clinical trials in surgery].
Proof of safety and effectiveness of surgical procedures follows the same scientific principles as for drugs. Control of bias and chance when evaluating new operations has to be considered and should generally be followed using randomized controlled trials (RCT). The expenditure for study design, execution and analysis can be substantial due to specific characteristics of surgical treatments. ⋯ Since 2004, new methods and procedures are being tested to demonstrate the feasibility of surgical RCTs through a grant program for surgical clinical trial centers in Germany. In six surgical trial centers, a number of surgical RCTs have been designed and conducted. The first results of high-quality surgical RCTs are described.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Apr 2009
[Clinical trials registers. Introduction to the topic and backgrounds].
It is a moral responsibility of those performing clinical studies towards patients, funding organizations, the scientific community and towards the general public to publish the results of clinical trials. Under-reporting of clinical trials with null or even negative results as well as over-reporting of trials with positive results can lead to a biased assessment of (new) treatments, which leads to overestimation of potential benefits and underestimation of potential risks. Comprehensive, publicly accessible clinical trial registries are now widely accepted as an essential tool to fill the information gap. Here, the background for implementing a clinical trials register in Germany is described, whereby publication bias, in particular, is addressed.