Blumle, A; Antes, G; Schumacher, M; Just, H; von Elm, E Clinical research projects at a German medical faculty: follow-up from ethical approval to publication and citation by others JOURNAL OF MEDICAL ETHICS, 34 (9): Art. No. e20 SEP 2008

[Eugene Garfield]

E-mail Address: bluemle at cochrane.de

Author(s): Blumle, A (Bluemle, A.); Antes, G (Antes, G.); Schumacher, M 
(Schumacher, M.); Just, H (Just, H.); von Elm, E (von Elm, E.) 

Title: Clinical research projects at a German medical faculty: follow-up 
from ethical approval to publication and citation by others 

Source: JOURNAL OF MEDICAL ETHICS, 34 (9): Art. No. e20 SEP 2008

Language: English 

Document Type: Article 

Keywords Plus: INTERNATIONAL-COMMITTEE; TRIAL REGISTRATION; RESEARCH 
PROTOCOLS; JOURNAL EDITORS; BIAS; STATEMENT; COHORT 

Abstract: Background: Only data of published study results are available 
to the scientific community for further use such as informing future 
research and synthesis of available evidence. If study results are 
reported selectively, reporting bias and distortion of summarised 
estimates of effect or harm of treatments can occur. The publication and 
citation of results of clinical research conducted in Germany was studied.
Methods: The protocols of clinical research projects submitted to the 
research ethics committee of the University of Freiburg (Germany) in 2000 
were analysed. Published full articles in several databases were searched 
and investigators contacted. Data on study and publication characteristics 
were extracted from protocols and corresponding publications.
Results: 299 study protocols were included. The most frequent study design 
was randomised controlled trial (141; 47%), followed by uncontrolled 
studies (61; 20%), laboratory studies (30; 10%) and non-randomised studies 
(29; 10%). 182 (61%) were multicentre studies including 97 (53%) 
international collaborations. 152 of 299 (51%) had commercial (co-)funding 
and 46 (15%) non-commercial funding. 109 of the 225 completed protocols 
corresponded to at least one full publication (total 210 articles); the 
publication rate was 48%. 168 of 210 identified publications (80%) were 
cited in articles indexed in the ISI Web of Science. The median was 11 
citations per publication (range 0-1151).

Conclusions: Results of German clinical research projects conducted are 
largely underreported. Barriers to successful publication need to be 
identified and appropriate measures taken. Close monitoring of projects 
until publication and adequate support provided to investigators may help 
remedy the prevailing underreporting of research. 

Addresses: Univ Med Ctr Freiburg, Dept Med Biometry & Stat, Inst Med 
Biometry & Med Informat, D-79104 Freiburg, Germany; Univ Med Ctr, Res Eth 
Comm, Freiburg, Germany; Univ Bern, Inst Social & Prevent Med, Bern, 
Switzerland 

Reprint Address: Blumle, A, Univ Med Ctr Freiburg, Dept Med Biometry & 
Stat, Inst Med Biometry & Med Informat, Stefan Meier Str 26, D-79104 
Freiburg, Germany. 

E-mail Address: bluemle at cochrane.de 

Cited Reference Count: 25 

Times Cited: 0 

Publisher: B M J PUBLISHING GROUP 

Publisher Address: BRITISH MED ASSOC HOUSE, TAVISTOCK SQUARE, LONDON WC1H 
9JR, ENGLAND 

ISSN: 0306-6800 

DOI: 10.1136/jme.2008.024521 

29-char Source Abbrev.: J MED ETHICS 

ISO Source Abbrev.: J. Med. Ethics 

Source Item Page Count: 6 

Subject Category: Ethics; Medical Ethics; Social Issues; Social Sciences, 
Biomedical
 
ISI Document Delivery No.: 343CE 

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