Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
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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.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Apr 2009
[Clinical trials in children--between the expectations of scientific requirements, the assurance of proven treatment and ethical demands].
Regulation (EC) No. 1901/2006 of the European Parliament and the Council dated 12 December 2008 on medicinal products for paediatric use is the result of a survey by the European Commission, concluding that children in the European Union are inadequately treated with medicinal products. The Regulation is addressed to the pharmaceutical industry with the intention to place medicinal products on the market and to the Member States to register all information on medicinal products for the treatment of children. ⋯ This will be supported by incentives and rewards. As a consequence of the requirement to conduct clinical trials in children the framework and conditions have to be defined and ethical considerations have to be respected.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Apr 2009
[Clinical trials: methodological requirements and interpretation].
Clinical trials are performed to answer a large variety of questions. Of special relevance is their use in testing and estimating the benefit of medical interventions. ⋯ Methods have been developed and improved during recent decades. This article describes essentials of modern clinical trial methodology.