The German clinical trials register: Challenges and chances of implementing a bilingual registry

Journal of Evidence-Based Medicine

Volumn 2, Issue 1, 2009, Pages 36-40

  Hasselblatt, Hanna ^a   Dreier, Gabriele ^a   Antes, Gerd ^a   Schumacher, Martin ^a  

^a UNIVERSITY OF FREIBURG   (Germany)

Author keywords

Clinical trial; German clinical trials register; Germany; Register; Trial registry

Indexed keywords

CLINICAL RESEARCH; CLINICAL TRIAL; FUNDING; GERMANY; MEDICAL ETHICS; MEDICAL INFORMATION; PRIORITY JOURNAL; PUBLICATION; REGISTER; REVIEW; WORLD HEALTH ORGANIZATION;

CLINICAL TRIALS AS TOPIC; GERMANY; HUMANS; LANGUAGE; REGISTRIES;

EID: 77953425253     PISSN: 17565383     EISSN: 17565391     Source Type: Journal    
DOI: 10.1111/j.1756-5391.2009.01001.x     Document Type: Review

References (29)

1. Dickersin K. How important is publication bias? A synthesis of available data. AIDS Education and Prevention 1997; 9: 15-21.
2. Pich J, Carne X,ArnaizJA, Gomez B, Trilla A, Rodes J. Role of a research ethics committee in follow-up and publication of results. Lancet 2003; 361: 1015-6.
3. Scherer RW, Langenberg P, von Elm E. Full publication of results initially presented in abstracts. Cochrane Database Systematic Reviews 2007; Issue 2. Art. No.: MR000005. DOI: 10.1002/14651858.MR000005.pub3.
4. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal. Selective Publication of Antidepressant Trials and its influence on apparent efficacy. New England Journal of Medicine 2008; 358: 252-60.
5. Chan AW, Hrobjartsson A, Haahr MT, G0tzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. Journal of the American Medical Association 2004; 291:2457-65.
6. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. Public Library of Science ONE 2008; 3: e3081.
7. Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: A review of publication and presentation. Public Library ofScience Medicine 2008; 5(11): e217.
8. Chan AW, Hrobjartsson A, J0rgensen KJ, G0tzsche PC, Altman DG. Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols. British Medical Journal 2008; 337: a2299.
9. Simes RJ. Publication bias: the case for an international registry of clinical trials. Journal of Clinical Oncology 1986; 4: 1529-41.
10. Dickersin K, Rennie D. Registering clinical trials. Journal ofthe American Medical Association 2003; 290: 516-22.
11. Johnson RT, Dickersin K. Publication bias against negative results from clinical trials: three of the seven deadly sins. Nature Clinical Practice Neurology 2007; 3: 590-1.
12. Antes G, Chalmers I. Under-reporting of clinical trials is unethical. Lancet 2003; 361: 978-9.
13. Grobler L, Siegfried N, Askie L, Hooft L, Tharyan P, Antes G. National and multinational prospective trial registries. Lancet 2008; 372: 1201-2.
14. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: A statement from the International Committee of Medical Journal Editors. New England Journal of Medicine 2004; 351: 1250.
15. Laine C, Horton R, DeAngelis CD, Drazen JM, Frizelle FA, Godlee F, et al. Clinical trial registration-looking back and moving ahead. New England Journal of Medicine 2007; 356:2734-6.
16. The World Medical Association. WMA The World Medical Association, Ferney-Voltaire c2003 [updated 22 October 2008]. www.wma.net/e/policy/b3.html (accessed 16 December 2008).
17. European Science Foundation. European Science Foundation, Strasbourg Cedex c2008 [updated 11 February 2003]. www.esf.org/media-centre/press-releases/ ext-single- news/article/press-release-on-registration-of-randomised- controlled-trials-175/news-browse/1.html (accessed 16 December 2008).
18. National Institutes of Health. National Institutes of Health, Bethesda, Maryland [updated 11 December 2008]. grants.nih.gov/grants/guide/notice-files/ NOT-OD-08-023.html (accessed 16 December 2008).
19. World Health Organization. World Health Organization, Geneva c2008 [updated 2008]. www.who.int/ictrp/en/ (accessed 16 December 2008).
20. World Health Organization. World Health Organization, Geneva c2008 [updated 2008]. www.who.int/ictrp/search/en/ (accessed 16 December 2008).
21. 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 2008; 34: e20.
22. DeReG - Deutsches Register fur somatische Gentransferstudien. DeReG, Freiburg. www.dereg.de (accessed 16 December 2008).
23. Dreier G, Cichutek K. Das Deutsche Register fur somatische Gentransferstudien - DeReG. Bundesgesundheitsblatt 2004; 47: 554-8.
24. Clinical Trial Registry of the University Medical Center Freiburg. Clinical Trials Center (Zentrum Klinische Studien Freiburg) ZKS, Freiburg. skl14b.ukl.uni-freiburg.de/zks/live/ uklregister/Oeffentlich/extern-en.html (accessed 16 December 2008).
25. German Clinical Trials Register Deutsches Register Klinischer Studien. German Clinical Trials Register, Freiburg [updated
26. December 2008]. www.germanctr.de (accessed 16 December 2008).
27. German Clinical Trials Register Deutsches Register Klinischer Studien. German Clinical Trials Register, Freiburg c2008 [updated 16 December 2008]. register.germanctr.de/drks/ start.faces (accessed 16 December 2008).
28. World Health Organization. World Health Organization, Geneva c2008 [updated 2008]. www.who.int/ictrp/network/trds/en/ index.html (accessed 16 December 2008).
29. ICMJE International Committee of Medical Journal Editors. [updated October 2008] www.icmje.org/jrnlist.html (accessed 16 December 2008).