In the past 15 years in Germany, approximately 13,000 clinical trials with more than a Million participants performed &ndash were; without a single serious incident. The Federal Institute for drugs and medical devices (BfArM) reported. The experts attribute this to the high Standards in this country and warn against outsourcing in emerging countries.
Clinical studies are the prerequisite for the development of new drugs. In addition, patients will be given the opportunity to get access to medicinal products not yet authorised, and to expand the possible treatment options. Since 2004, clinical trials in Europe must be approved by the authorities. By strict EU guidelines and regulatory controls could be achieved, that in Germany there were, as yet, no serious adverse event in a clinical trial. "At the same time, we see with our high Standards of patient and subject safety, with concern that more and more studies in emerging countries outside of Europe shifted werden", Professor Dr. Karl Broich, President, BfArM says.
Safety standards in Germany are very high
Before a medicinal product may be applied for the first Time in humans, and tested, it has to undergo numerous preliminary examinations. First Tests in the test tube is positive, it will be examined in a series of animal experiments, the possible effects on the organism. "Only if these preclinical studies are internationally conducted standardized, show no evidence of increased risks, a new drug for the first time in humans clinically tested werden", the authority explained.
The clinical study is to be conducted in Germany, an application must be submitted that is reviewed by scientists at the BfArM. Around 60 percent of all initial applications are rejected, the BfArM then requests repairs or subsequent deliveries. "In most cases, these requirements are implemented, so that approximately 95 percent of all clinical trials applied for können" be approved;, it is said in the press release. A further condition is the Approval of an ethics Commission.
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