History of the Copenhagen Trial Unit

Background for establishing the CTU

Denmark has a long tradition within health science research, achieving a strong position within the clinical research field (1-3).

In 1995, the NASTRA-report 'Proposal for a national strategy for health science' was developed (4). The report recommended a strengthening of the Danish health science research by giving high priority to the areas where Danish research already had a strong position. One of the four areas recommended was clinical research with preventive, diagnostic, therapeutic, and nursing care objectives. The other three areas were genetic research, brain research, and preventive research.

Some of the currently applied interventions within the health care sector have not been subjected to adequate evaluation of the efficacy and socioeconomic impact. A large number of new interventions awaits to become assessed before being introduced into clinical practise. It is, therefore, important to support the research that evaluates the effect of the already implemented interventions and the research that evaluates the effect of new interventions before their implementation. The selection of appropriately designed studies - i.e., randomised clinical trials - becomes of central importance (5).

The European Good Clinical Practice (GCP) guidelines and EU directives and regulations for clinical research have contributed to the rise of clinical research to a higher standard but have also put a heavy workload on the clinical researchers. Collaboration between clinical researchers and clinical trial units, sharing the ambition to secure scientific quality in the conduct of trials, has become very important (5,6).

In order to evaluate the possibility of establishing a centre for clinical research within the Copenhagen Health Services, more than 40 research centres in Europe and North America were visited in 1993. Extensive interviews among key researchers in these institutions were carried out. Based on these investigations, a report was prepared (6). The report was then circulated internationally and nationally for comments and eventually formed the basis for the proposal to establish the Copenhagen Trial Unit (CTU) (6).

Clinicians, various research institutions, and the drug industry, at home and abroad, supported the proposal for establishing a centre for clinical research. Many national organisations and institutions were of the opinion that the establishment of a clinical trial unit could contribute substantially to strengthen the Danish clinical research.

In October 1994, the Copenhagen City Council decided to establish the Copenhagen Trial Unit - the CTU. On June 1, 1995, Christian Gluud, was appointed Head of the Department. On January 1, 1996, after a phase of planning and preparation, the CTU was set up. During the first years, the CTU was core funded by the Copenhagen Health Services. Since 2007 the funding of the CTU has been taken over by the Danish state.

References:

(1) Gluud C, Nikolova D. Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years. Trials. 2007: 8: 7. View.

(2) Wolff RF, Reinders S, Barth M, et al. Distribution of country of origin in studies used in Cochrane reviews. P L o S One. April 2011: 6(4): e18798. View.

(3) Herrmann KH, Wolff R, Scheibler F, et al. All nations depend on the global knowledge pool – Analysis of country of origin of studies used for health technology assessments in Germany. P L o S One. March 2013: 8(3): e59213. View.

(4) The National Strategy Committee for Health Science Research (NASTRA). Proposal for a national strategy for health science. Report #1284. Copenhagen: Ministry of Research; 1995. View.

(5) Jakobsen JC, Gluud C. The necessity of randomized clinical trials. British Journal of Medicine & Medical Research. 2013;3(4):1453-68. View.

(6) Gluud C. Report on proposal to form a Clinical Trial Unit of the Copenhagen Health Services. Copenhagen: Copenhagen Health Services; November 1993. View.

 

Development per year of publications and citations as well as the Hirsch (h)-index

Based on Web of Science searches, the development in publications per year from The CTU is shown below:

Graph1

The development of citations per year is shown below. The h-index is 64 per 1st of March 2017:

Graph2

 

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