[1] | Stewart PM, Stears A, Tomlinson JW, Brown MJ (2008) Regulation – the real threat to clinical research. BMJ 337: 1085–1087.
|
[2] | (2002) ICH Good Clinical Practice CPMP/ICH/135/95. Available: http://www.emea.europa.eu/pdfs/human/ich?/013595en.pdf. Accessed 6 July 2009.
|
[3] | Baum M, Buchanan M, Baselga J, Cataliotti L, Jassem J, et al. (2007) The future of breast cancer research in danger. Eur J Can 38: 2210–2213.
|
[4] | (2001) Directive 2001/20/ EC of the European parliament and of the council of 4 April 2002 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities. L121. : 34–44. Available: http://ec.europa.eu/enterprise/pharmaceu?ticals/eudralex/vol-1/dir_2001_20/dir_20?01_20_en.pdf. Accessed 6 July 2009.
|
[5] | (2004) The Medicines for Human Use (Clinical Trials) Regulations 2004. Available: http://www.opsi.gov.uk/si/si2004/2004103?1.htm. Accessed 6 July 2009.
|
[6] | MHRA website Available: http://www.mhra.gov.uk/index.htm. Accessed 6 July 2009.
|
[7] | (2005) Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. Official Journal of the European Communities L91: 13–19. Available: http://ec.europa.eu/enterprise/pharmaceu?ticals/eudralex/vol-1/dir_2005_28/dir_20?05_28_en.pdf. Accessed 6 July 2009.
|
[8] | (2005) Draft guidance on ‘specific modalities’ for non-commercial clinical trials referred to in Commission Directive 2005/28/EC laying down the principles and detailed guidelines for good clinical practice. Available: http://ec.europa.eu/enterprise/pharmaceu?ticals/pharmacos/docs/doc2006/07_2006/gu?ide_noncommercial_2006_07_27.pdf. Accessed 6 July 2009.
|
[9] | (2006) Statutory Instrument 2006 No. 1928. The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006. Available: http://www.opsi.gov.uk/si/si2006/2006192?8.htm. Accessed 6 July 2009.
|
[10] | (2006) Statutory Instrument 2006 No. 2984. The Medicines for Human Use (Clinical Trials) Amendment (No. 2) Regulations 2006. Available: http://www.opsi.gov.uk/si/si2006/2006298?4.htm. Accessed 6 July 2009.
|
[11] | (2006) Explanatory Memorandum to the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 No. 1928. Available: http://www.opsi.gov.uk/si/em2006/uksiem_?20061928_en.pdf. Accessed 6 July 2009.
|
[12] | (2006) Explanatory Memorandum to the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 No. 2984. Available: http://www.opsi.gov.uk/si/em2006/uksiem_?20062984_en.pdf. Accessed 6 July 2009.
|
[13] | Anonymous (2003) Who's afraid of the European Clinical Trials Directive? Lancet 361: 2167.
|
[14] | Sullivan R, Law K (2003) Cancer research UK says… Lancet Onc 4: 718–719.
|
[15] | Morice AH (2003) The death of academic clinical trials. Lancet 361: 1568.
|
[16] | Flavell DJ, Flavell SU, Sullivan R (2003) European Clinical Trials Directive: responses made to MHRA consultation letter MLX 287. Lancet 3623: 1415.
|
[17] | Anon (2004) EU clinical trials directive: 0% inspiration, 100% perspiration? Lancet Neur 3: 321.
|
[18] | Meunier F, Dubois N, Negrouk A, Rea LA (2003) Throwing a wrench in the works? Lancet Onc 4: 717–718.
|
[19] | Williams N (2004) Breast cancer research and the European Union Clinical Trials Directive. Breast Can Res 6: 145–147.
|
[20] | Saghatchian M, Tursz T (2003) Organisation of European Cancer Institutes says… Lancet Onc 4: 718.
|
[21] | Nundy S, Gulhati CM (2005) A new colonialism? Conducting clinical trials in India. N Engl J Med 352: 1633–1636.
|
[22] | Woods K (2004) Implementing the European clinical trials directive - Discussions continue in the European Commission and the United Kingdom. BMJ 328 7434: 240–241.
|
[23] | Singer EA, Mullner M (2002) Implications of the EU directive on clinical trials for emergency medicine - Many trials in emergency medicine will not be possible. BMJ 324: 1169–1170.
|
[24] | Druml C, Singer EA (2004) The European Directive: a further blow to science in intensive care medicine in Austria. Inten Care Med 30: 335.
|
[25] | Hall JE, Diaz-Navarro C (2005) Living with the European Clinical Trials Directive: one year on. Anaesthesia 60: 949–951.
|
[26] | Bosch X (2005) Europe's restrictive rules strangling clinical research. Nat Med 11: 1260.
|
[27] | Hartmann M, Hartmann-Vareilles F (2006) The clinical trials directive: how is it affecting Europe's noncommercial research? PLoS Clin Trials 1: e13. doi:10.1371/journal.pctr.0010013.
|
[28] | Sinha G (2006) European move affects academic trials research. J Nat Can Inst 98: 1100–1101.
|
[29] | Hemminki A, Kellokumpu-Lehtinen PL (2006) Harmful impact of EU clinical trials directive - Academic clinical research in cancer seems to have no future in Europe. BMJ 332: 501–502.
|
[30] | Rice M (2006) New data on clinical trials directive in Europe show few favourable outcomes. J Nat Can Inst 98: 159–160.
|
[31] | Hanning CD, Rentowl P (2006) Harmful impact of EU clinical trials directive - Trial of alerting drug in fibromyalgia has had to be abandoned. BMJ 332: 666.
|
[32] | Watson M (2006) Harmful impact of EU clinical trials directive … and so has trial of melatonin in cancer related weight loss. BMJ 332: 666.
|
[33] | Mitchell CD (2006) Harmful impact of EU clinical trials directive … while paediatric oncology is being scuppered. BMJ 332: 666.
|
[34] | Cannell E (2007) Clinical Trials Directive slows registration of paediatric studies. Lancet Onc 8: 10.
|
[35] | Welzing L, Harnischmacher U, Weyersberg A, Roth B (2007) Consequences of Directive 2001/20/EC for investigator-initiated trials in the paediatric population - a field report. Eur J Ped; 166: 1169–1176.
|
[36] | Mitchell C (2007) Clinical trials in paediatric haematology-oncology: are future successes threatened by the EU directive on the conduct of clinical trials? Arc Dis Child 92: 1024–1027.
|
[37] | European Parliament (2006) EU Regulation 1901/2006. Available: http://ec.europa.eu/enterprise/pharmaceu?ticals/eudralex/vol-1/reg_2006_1901/reg_?2006_1901_en.pdf. Accessed 6 July 2009.
|
[38] | Lehmann B (2008) Regulation (EC) No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations. Child Adolesc Psychiatry Ment Health 2: 37.
|
[39] | Permanand G, Mossialos E, McKee M (2007) The EU's new paediatric medicines legislation: serving children's needs? Arc Dis Child 92: 808–811.
|
[40] | Hearn J, Sullivan R (2007) The impact of the ‘Clinical Trials’ directive on the cost and conduct of non-commercial cancer trials in the UK. Eur J Can 43: 8–13.
|
[41] | Califf RM (2007) Clinical trials bureaucracy: unintended consequences of well-intentioned policy. Clin Trials 6: 496–502.
|