The effect of the European Clinical Trials Directive on published drug research in anaesthesia

Anaesthesia

Volumn 64, Issue 9, 2009, Pages 984-989

  Walker, E ^a   Hankins, M C ^b   White, Stuart M ^a  

^a ROYAL SUSSEX COUNTY HOSPITAL   (United Kingdom)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANESTHESIA; ARTICLE; BIBLIOMETRICS; DRUG RESEARCH; EUROPE; EUROPEAN CLINICAL TRIALS DIRECTIVE; GENERAL ANESTHESIA; HUMAN; LAW; PATIENT; PUBLICATION; SCIENTIFIC LITERATURE; UNITED KINGDOM; VOLUNTEER;

ANESTHESIOLOGY; BIBLIOMETRICS; BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; CLINICAL TRIALS, PHASE IV AS TOPIC; DRUG DISCOVERY; DRUGS, INVESTIGATIONAL; EUROPE; EUROPEAN UNION; HUMANS; LEGISLATION, DRUG; PERIODICALS AS TOPIC; PUBLISHING;

EID: 68149163178     PISSN: 00032409     EISSN: 13652044     Source Type: Journal    
DOI: 10.1111/j.1365-2044.2009.06011.x     Document Type: Article

References (32)

1. European Parliament and Council of the European Union. The European Clinical Trials Directive (ECTD) (2001/20/EC). http://www.wctn.org.uk/downloads/ EU-Directive/Directive.pdf (accessed 10 April 2009).
2. Stewart PM, Stears A, Tomlinson JW, Brown MJ. Regulation - the real threat to clinical research. British Medical Journal 2008; 337: 1085-1087
3. Griffin GE, Brown M, Gilmore I, et al. UK research trials are on verge of extinction. The Times 2009; January 14th, http://www.timesonline.co.uk/tol/ comment/letters/ article5511067.ece (accessed 10 April 2009).
4. Duley L, Antman K, Arena J, et al. Specific barriers to the conduct of randomised trials. Clinical Trials 2008; 5: 40-48
5. Hall JE, Diaz-Navarro C. Living with the European Clinical Trials Directive: one year on. Anaesthesia 2005; 60: 949-951 (Pubitemid 41387847)
6. Sheard L, Tompkins CNE, Wright NMJ, Adams CE. Noncommercial clinical trials of a medicinal product: can they survive the current process of research approvals in the UK? Journal of Medical Ethics 2006; 32: 430-434
7. Hackshaw A, Farrant H, Bulley S, Secki MJ, Ledermann JA. Setting up non-commercial clinical trials takes too long in the UK: findings from a prospective study. Journal of the Royal Society of Medicine 2008; 101: 299-304.
8. Hoey R. The EU clinical trials directive: 3 years on. Lancet 2007; 369: 1777-1778
9. Hearn J, Sullivan R. The impact of the 'Clinical Trials' directive on the cost and conduct of non-commercial cancer trials in the UK. European Journal of Cancer 2007; 43: 8-13. (Pubitemid 46054481)
10. Hirsch L. Trial registration and results disclosure: impact of US legislation on sponsors, investigators, and medical journal editors. Current Medical Research and Opinion 2008; 24: 1683-1689
11. DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical Trial Registration. A statement from the International Committee of Medical Journal Editors. Journal of the American Medical Association 2004; 292: 1363-1364
12. Berendt L, Hakansson C, Bach KF, et al. Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006. British Medical Journal 2008; 336: 33-35
13. National Research Ethics Service. NRES Plan 2008-2009. http://www.nres.npsa.nhs.uk/EastSiteWeb/GatewayLink. aspx?alId=4627 (accessed 10 April 2009).
14. National Research Ethics Service. NRES Activity Data. http://www.nres.npsa.nhs.uk/EastSiteWeb/GatewayLink. aspx?alId=4627 (accessed 10 April 2009).
15. Feneck R, Natarajan N, Sebastian R, Naughton C. Decline in research publications from the United Kingdom in anaesthesia journals from 1997 to 2006. Anaesthesia 2008; 63: 270-275
16. Boldt J, Maleck W, Koetter KP. Which countries publish in important anesthesia and critical care journals? Anesthesia and Analgesia 1999; 88: 1175-1180
17. Swaminathan M, Phillips-Bute BG, Grichnik KP. A bibliometric analysis of global clinical research by anaesthesia departments. Anesthesia and Analgesia 2007; 105: 1741-1746 (Pubitemid 350190573)
18. Szokol JW, Murphy GS, Avram MJ, Nitsun M, Wynchenko TM, Vender JS. Declining proportion of publications by American authors in major anaesthesiology journals. Anesthesia and Analgesia 2003; 96: 513-517
19. Pandit JJ. Anaesthetic research in the United Kingdom: publishing or perishing? Anaesthesia 2008; 63: 225-227
20. Pandit JJ. The national strategy for academic anaesthesia. A personal view on its implications for our specialty. British Journal of Anaesthesia 2006; 96: 411-414
21. Pandit JJ. A National Strategy for Academic Anaesthesia. London: Royal College of Anaesthetists, 2005. http:// www.rcoa.ac.uk/docs/Academic-full.pdf (accessed 23 March 2009).
22. Walker E, White SM. Difficulties faced by 'non-academic' researchers. Anaesthesia 2008; 63: 1017.
23. Hemminki A, Kellokumpu-Lehtinen PL. Harmful impact of EU clinical trials directive. British Medical Journal 2006; 332: 501-502
24. Bruzzi P. Non-drug industry funded research. British Medical Journal 2008; 336: 1-2.
25. Rowbotham DJ. National Institute for Academic Anaesthesia (NIAA). Royal College of Anaesthetists Bulletin 2008; 49: 2516-2517
26. Central Committee on Research involving Human Subjects (CCMO). http://www.ccmo-online.nl (accessed 10 April 2009).
27. Central Office for Research Ethics Committees. Building on Improvement: Implementing the Recommendations of the Report of the ad hoc Advisory Group on the Operation of NHS Research Ethics Committees. London: Central Office for Research Ethics Committees, 2006.
28. European Science Foundation. Investigator-driven clinical trials. 2009. http://www.esf.org/fileadmin/links/EMRC/ FL-IDCT.pdf (accessed 10 April 2009).
29. Mitchell C. Clinical trials in paediatric haematology- oncology: are future successes threatened by the EU directive on the conduct of clinical trials? Archives of Diseases in Childhood 2007; 92: 1024-1027
30. Pritchard-Jones K. Clinical trials for children with cancer in Europe - still a long way from harmonisation: a report from SIOP Europe. European Journal of Cancer 2008; 44: 2106-2111
31. Wiedermann CJ, Almici M, Mangione S, Giarratano A, Mayr O. Clinical research in Italy in adult patients unable to consent: after implementation of the European Union's Directive 2001/20/CE. Intensive Care Medicine 2007; 33: 316-318
32. Rice M. New data on Clinical Trials Directive in Europe show few favorable outcomes. Journal of the National Cancer Institute 2006; 98: 159-160 (Pubitemid 43205475)