A coalition of pharmaceutical industry and academic medical research associations based in Germany is calling for the indefinite suspension of a new European system to register clinical trials, citing “serious shortcomings” that need to be fixed.
In a strongly worded statement released late last month, the organizations expressed concern that the clinical trial information system, or CTIS, suffers from “deficiencies” that have only worsened since it debuted this past January and is “largely unmanageable for all those involved.” Each new investigative trial must be submitted to this registration system.
The CTIS electronic portal was launched as part of a broader effort to enhance clinical transparency across the European Union and the European Economic Area. The goal of the new registration system is to change the way applications for authorizing clinical trials are submitted, as well as provide a new approach for supervision.
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