Clinical Trials Register

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As clinical trials registry (English Clinical Trials Registry , CTR) or trials register are searchable databases referred to in which to clinical trials are stored data, such as educational qualifications, brief descriptions, inclusion and exclusion criteria, study status and endpoints.

background

Clinical studies are carried out to test the effectiveness and tolerability of medical interventions (especially drugs , medical devices , but also surgical treatment techniques or psychological forms of therapy ) and to use the results to provide the basis for evidence-based treatment . In order to ensure and increase transparency in clinical research, various governments and international organizations require publicly accessible registers of clinical studies. In some countries (e.g. the USA) there are laws that oblige those who conduct clinical studies (at least in the case of drug studies) to register their studies in a publicly accessible register before the start of the study. Since the 2013 revision, the Helsinki Declaration also requires study registration. In addition, prospective registration of clinical studies, as required by the International Committee of Medical Journal Editors , is increasingly becoming a prerequisite for scientific publication of study data in specialist journals .

Registration of clinical studies internationally

The largest and best-known public registry of clinical trials is the American registry ClinicalTrials.gov, which is maintained by the US National Institutes of Health . There are also many other national study registers and, for example, disease-specific registers that are maintained by various organizations. The International Clinical Trials Registry Platform (ICTRP) was founded by the World Health Organization (WHO) to bundle and coordinate activities for the registration of clinical trials worldwide . All participating registers, which have to meet certain quality standards, regularly bring their data together in the meta-register set up by the WHO in 2007, thus enabling a global search for clinical studies.

In the European Union, data on the clinical studies carried out in the Member States as well as in Iceland, Liechtenstein and Norway are collected in the EudraCT registry operated by the European Medicines Agency . Parts are available to the public: The EU Clinical Trials Register contains information about pediatric clinical studies and phase II to IV studies in adults as required by the Pediatric Investigation Plan (PIP) .

Registration of clinical studies in Germany

For drug studies in Germany, the GCP regulation requires registration in the EudraCT (a register of the European Union) before an application for approval for the study can be submitted. Scientific institutions and research funding organizations such as the Federal Ministry of Education and Research (BMBF) and the German Research Foundation (DFG) require the registration of all clinical studies in a public register as a prerequisite for funding. Since 2008, the “German Register of Clinical Studies” has been a public, free national register of clinical studies in Germany that is a member of the WHO network and meets the ICMJE standards. In addition, there are numerous local or disease-specific registers in Germany that take into account the particularities of certain diseases or regions.

The PharmNet.Bund portal provides information on clinical drug trials approved in Germany since 2004. Anyone can view the data on clinical studies there free of charge.

The German Clinical Trials Register (DRKS) will permanently switch to the German Institute for Medical Documentation and Information (DIMDI) on July 1, 2017 .

Web links

Individual evidence

  1. ↑ G. Antes, G. Dreier, H. Hasselblatt, A. Blümle, M. Schumacher: Register for clinical studies. Introduction to the topic and background . In: Federal Health Gazette Health Research Health Protection . 52, No. 4, April 2009, pp. 459-462. doi : 10.1007 / s00103-009-0832-6 . PMID 19343283 .
  2. ↑ International Committee of Medical Journal Editors: Clinical Trial Registration: Looking Back and Moving Ahead. ( Memento of May 14, 2011 in the Internet Archive ) Retrieved March 17, 2011.
  3. ^ ClinicalTrials.gov , US National Library of Medicine database.
  4. ↑ List of the registries involved in the International Clinical Trials Registry Platform .
  5. ↑ Guide for submitting applications for clinical trials. (PDF; 203 kB), accessed on May 16, 2011.
  6. ↑ Information about clinical studies becomes transparent. ( Memento from February 10, 2013 in the web archive archive.today ) Press release from the press and public relations department DIMDI of December 3, 2012.
  7. ^ Study registration in Germany - description from Cochrane.