Regulatory impediments jeopardizing the conduct of clinical trials in Europe funded by the National Institutes of Health

Clinical Trials

Volumn 7, Issue 6, 2010, Pages 705-718

  Neaton, James D ^a   Babiker, Abdel ^b   Bohnhorst, Mark ^c   Darbyshire, Janet ^b   Denning, Eileen ^a   Frishman, Arnie ^c   Grarup, Jesper ^d   Larson, Gregg ^a   Lundgren, Jens ^d  

^a UNIVERSITY OF MINNESOTA   (United States)

^b MRC CLINICAL TRIALS UNIT   (United Kingdom)

^c UNIVERSITY OF MINNESOTA   (United States)

^d UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRETROVIRUS AGENT;

ARTICLE; CLINICAL TRIAL (TOPIC); COST; EUROPE; EUROPEAN UNION; FUNDING; GOVERNMENT; HEALTH INSURANCE; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; NATIONAL HEALTH ORGANIZATION; PRIORITY JOURNAL;

ANTI-HIV AGENTS; CLINICAL PROTOCOLS; CLINICAL TRIALS AS TOPIC; DRUG AND NARCOTIC CONTROL; EUROPE; EUROPEAN UNION; GOVERNMENT REGULATION; GUIDELINE ADHERENCE; GUIDELINES AS TOPIC; HIV INFECTIONS; HUMANS; INTERNATIONALITY; MULTICENTER STUDIES AS TOPIC; NATIONAL INSTITUTES OF HEALTH (U.S.); UNITED STATES;

EID: 78650313752     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774510376547     Document Type: Article

References (34)

1. European Parliament and Council of the European Union. Directive 2001/20/EC of the European Parliament and the Council of 4 April 2001. 2001 ; 121: 34-44. Available at: http://ec.europa.eu/enterprise/pharmaceuticals/ eudralex/vol-1/dir-2001-20/dir-2001-20-en.pdf (accessed 25 May 2009 ).
2. Flavell DJ, Flavell SU, Sullivan R. European clinical trials directive: responses made to MHRA consultation letter MLX 287. Lancet 2003 ; 362: 1415.
3. Williams N. Breast cancer research and the European union of clinical trials directive. Breast Cancer Res 2004 ; 6: 145-47.
4. Baeyens AJ Impact of the European clinical trials directive on academic clinical research. Med Law 2004 ; 23: 103-10.
5. Hartmann M., Hartmann-Vereilles F. The clinical trials directive: how is it affecting Europe's noncommercial research? PLos Clin Trials 2006 ; 1: e13.
6. Hearn J., Sullivan R. The impact of the 'Clinical Trials' directive on the cost and conduct of non-commercial trials in the UK. Eur J Cancer 2007 ; 43: 8-13.
7. Mitchell C. Clinical trials in paediatric haematology-oncology: are future successes threatened by the EU directive on the conduct of clinical trials? Arch Dis Child 2007 ; 92: 1024-27.
8. Lambers Heerspink HJ, Dobre D., Hillege HL, et al. Does the European clinical trials directive really improve clinical trial approval time? Br J Clin Pharmacol 2008 ; 66: 546-50.
9. Pritchard-Jones K. Clinical trials for children with cancer in Europe - still a long way from harmonization: a report from SIOP Europe. Eur J Cancer 2008 ; 44: 2106-11.
10. Osborne JP, O'Callaghan FJK. Running an international paediatric non-commercial clinical trial. Arch Dis Child 2009 ; 94: 729-33.
11. European Commission. Assessment of the functioning of the 'Clinical Trials Directive' 2001/20/EC. Public Consultation Paper. September 10, 2009. Available at: http://ec.europa.eu/enterprise/pharmaceuticals/clinicaltrials/ clinicaltrials-en.htm (accessed 28 November 2009 ).
12. McMahon AD, Conway DI, MacDonald TM, McInnes GT The unintended consequences of clinical trials regulations. PLoS Med 2009 ; 6: e1000131.
13. European Forum for Good Clinical Practice (EFGCP). Impact on clinical research of European Legislation (ICREL) February 2009. Available at: http://www.efgcp.be/downloads/icrel-docs/Final-report-ICREL.pdf (accessed 7 January 2010 ).
14. http://history.nih.gov/01docs/historical/2020b.htm. (accessed 30 May 2009 ).
15. ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice E6 (R1) (10 June 2006 ).
16. Goudsmit F., Rios C., Wadlund J. Insuring international clinical trials: navigating the quirks and avoiding the quagmires. J Biolaw & Bus 2005 ; 8: 3-7.
17. Chung CH, Freiberger A., Kalkum M., et al. CRASH2 in Germany [ISRCTN86750102]. Trials 2006 ; 7: 22.
18. European Commission. The rules governing medicinal products in the European Union. Volume 10 - Guidance Documents Applying to Clinical Trials. Questions and Answers, Version 4.0 European Commission, Health and Consumers Directorate-General, Brussels, 2009.
19. Maschke KJ US and UK policies governing research with humans. Psychopharmacology (Berl) 2003 ; 171: 47-55.
20. OHRP FAQ#14 on IRB registration. Available at: http://www.hhs.gov/ohrp/ IRBfaq.html#q1 (accessed 22 December 2009 ).
21. DHHS Panel on antiretroviral guidelines for adults and adolescents - a working group of the office of AIDS research advisory council (OARAC). Guidelines for the use of antiretroviral agents in HIV-1 infected adults and adolescents (3 November 2008 ).
22. Califf RM, Morse MA, Wittes J., et al. Toward protecting the safety of participants in clinical trials. Control Clin Trials 2003 ; 24: 256-71.
23. U.S.C. § 1341(a)(1)(A)(2000). Antideficiency Act Reports Fiscal Year 2005.
24. Minnesota Statutes, Section 3.736. Available at: http://www.revisor.mn. gov/bin/getpub.php?pubtype=STAT-CHAP-SEC&year=current§ion=3. 736&image.x=18&image.y=3 (accessed 29 December 2009 ).
25. Comparative effectiveness research funding. Available at: http://www.hhs.gov/recovery/programs/cer/index.html (accessed 28 August 2009 ).
26. Halkidou K., Tunis S., Lopert R., et al. Comparative effectiveness research and evidence-based health policy: experience from four countries. Milbank Q 2009 ; 87: 339-67.
27. Glickman SW, McHutchison JG, Peterson E., et al. Ethical and scientific implications of globalization of clinical research. N Engl J Med 2009 ; 360: 816-23.
28. Burman W., Reves RR, Cohn DL, Schooley RT Breaking the camel's back: multicenter clinical trials and local institutional review boards. Ann Intern Med 2001 ; 134: 152-57.
29. Emanuel EJ, Wood A., Fleischman A., et al. Oversight of human participants research: identifying problems to evaluate reform proposals. Ann Intern Med 2004 ; 141: 282-91.
30. Jester PM, Tilden SJ, Li Y., et al. W. Regulatory challenges: lessons from recent West Nile virus trials in the United States. Contemp Clin Trials 2006 ; 27: 254-59.
31. Duley L., Antman K., Arena J., et al. Specific barriers to the conduct of randomized trials. Clin Trials 2008 ; 4: 40-48.
32. Report of the Equivalent Protections Working Group. Department of Health and Human Services (17 July 2003 ).
33. Delegation of the European Commission to the USA. Funding opportunities for transatlantic health research June 2008. Available at: http://www.eurunion. org/STETransatlHealthRsrchBroch.pdf (accessed 29 December 2009 ).
34. Forward Look - Investigator-driven Clinical Trials. European Science Foundation. Available at: www.esf.org/publications/forward-looks.html (accessed 14 July 2010 ).