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.
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and networking platform access.
Already have an account? Log in
Already have an account? Log in
About the Author Reprints
To submit a correction request, please visit our Contact Us page.
STAT encourages you to share your voice. We welcome your commentary, criticism, and expertise on our subscriber-only platform, STAT+ Connect