EudraCT

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EudraCT ( E uropean U nion D rug R egulating A uthorities C linical T rials) is a registry for clinical trials , with human since 2004 medicinal products in the European Union are carried out. EudraCT is operated by the European Medicines Agency and used by the Member States' Medicines Authorities to approve and monitor clinical trials.

Purpose and legal basis

The EudraCT registry was introduced to increase the transparency of clinical studies carried out in the EU and to improve the safety of study participants through better monitoring. The legal basis for the structure is Article 11 of Directive 2001/20 / EC on the application of good clinical practice . In Germany, the GCP regulation stipulates that a planned clinical drug study must be registered in EudraCT before an application for approval for the study can be submitted. The register went into operation on May 1, 2004, and since then well over 10,000 studies have been registered by the end of 2007.

construction

The allocation of a EudraCT number is central to the register; this is a central means of identification for a clinical study in Europe. The register is divided into a part open to applicants and an authority part.

In the open part, the applicants provide key data on the planned clinical study, for example brief information on the planned test drug, the aim of the study, the study design and the planned test centers. This data is stored in an XML file; at the same time a EudraCT number is generated. After the EudraCT entry, a detailed application for approval of the clinical study must be submitted to the competent national authority, stating the EudraCT number and attaching the XML file.

In the authority section, the approving national authority provides excerpts from the application for approval and, if necessary, changes to it, information on the ethics committee's opinion , notifications about the completion of the study and information on GCP and GMP inspections.

The registry has an interface to the Clinical Trials module of the EudraVigilance database, where suspected cases of unexpected serious side effects of an investigational drug ( SUSARs ) are documented. SUSARs must be reported by the investigator to the sponsor and by the sponsor to the national authority within a short period of time; this in turn takes care of the entries in the European database.

Access

Since the EudraCT was put into operation in 2004, the limited access that only allowed the national authorities (in Germany the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute ), the European Medicines Agency and the EU Commission has been criticized . In March 2011, the European Medicines Agency released the EU Clinical Trials Register for the general public, which contains data from EudraCT that have been released to the public. This is information about the pediatric clinical studies prescribed by the pediatric investigation plan (PIP) and about phase II – IV studies in adults. The legal basis is provided by Article 57 (2) of Regulation (EC) No. 726/2004 and Article 41 of Regulation (EC) No. 1901/2006 on medicinal products for children .

In addition to public access, special access options for ethics committees involved in the approval process for clinical studies and the expansion of EudraCT into a central portal for submitting all documents for approval applications for clinical studies are discussed.

Individual evidence

  1. ↑ Krafft, H. (2005) The EudraCT database at the European Medicines Agency for the recording of clinical trials in Europe. In: Bundesgesundheitsblatt 48: 453-8 PMID 15830257
  2. ↑ Harro Albrecht: medicine: Blocked register. In: zeit.de. April 22, 2004, accessed September 11, 2019 .
  3. ^ European Commission-European Medicines Agency Conference on the Operation of the Clinical Trials Directive (Directive 2001/20 / EC) and Perspectives for the Future Conference held on October 3, 2007 at the EMEA, London - REPORT ON THE CONFERENCE -. (PDF; 643 kB) In: ema.europa.eu. November 30, 2007, accessed September 11, 2019 .

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