Review of new regulations for the conduct of clinical trials of investigational medicinal products

BJOG: An International Journal of Obstetrics and Gynaecology

Volumn 114, Issue 8, 2007, Pages 917-921

  Bollapragada, S S ^a   Norrie, J D ^b   Norman, J E ^a  

^a UNIVERSITY OF GLASGOW   (United Kingdom)

^b UNIVERSITY OF ABERDEEN   (United Kingdom)

Author keywords

Clinical trial regulations; EU directive; Good clinical practice

Indexed keywords

CLINICAL PROTOCOL; CLINICAL TRIAL; DRUG MONITORING; DRUG RESEARCH; DRUG SURVEILLANCE PROGRAM; GYNECOLOGY; HUMAN; INFORMATION PROCESSING; INFORMED CONSENT; INTERNET; MEDICAL ETHICS; OBSTETRICS; PRIORITY JOURNAL; PUBLISHING; QUALITY CONTROL; REGISTRATION; REVIEW; STATISTICAL ANALYSIS;

CLINICAL PROTOCOLS; CLINICAL TRIALS; DRUGS, INVESTIGATIONAL; INTERNET; PUBLISHING;

EID: 34447329589     PISSN: 14700328     EISSN: 14710528     Source Type: Journal    
DOI: 10.1111/j.1471-0528.2007.01415.x     Document Type: Review

References (22)

1. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 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. OJ 2001 L121 : 34 44.
2. Medicines for Human Use (Clinical Trials) Regulations 2004. The statuary instrument which transposes the EU Directive into UK law www.mhra.gov.uk/home/ groups/l-unit1/documents/websiteresources/con2022633.pdf Accessed 19 February 2007.
3. The European Commission in consultation with the Member States and the European Medicines Agency. The Rules Governing Medicinal Products in the European Union. 2006 http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/ homev10.htm Accessed 19 February 2007.
4. Medicines and Healthcare products Regulatory Agency. MHRA Guide to What is a Medicinal Product. 2007 www.mhra.gov.uk/home/idcplg?IdcService= GET_FILE&ID=32803&noSaveAs=0&Rendition=WEB Norwich, UK : Her Majesty's Stationary Office. Accessed 19 February 2007.
5. The ICH Expert Working Group. ICH CPMP/768/97 E6(R1) Good Clinical Practice: Consolidated Guideline. 1996 www.ich.org/LOB/media/MEDIA482.pdf Accessed 19 February 2007.
6. UK Clinical Research Network (www.ukcrn.org.uk www.ukcrn.org.uk/index/ training Accessed 19 February 2007.
7. MHRA clinical trial algorithm www.mhra.gov.uk/home/groups/l-unit1/ documents/websiteresources/con009394.pdf Accessed 19 February 2007.
8. Clinical trials tool kit (www.ct-toolkit.ac.uk www.ct-toolkit.ac.uk /_db/_documents/sponsorship.pdf Accessed 19 February 2007.
9. The Lancet Neurology. EU clinical trials directive: 0% inspiration, 100% perspiration? Lancet Neurol 2004 3 : 321.
10. NHS Research and Development forum www.rdforum.nhs.uk Accessed 19 February 2007.
11. 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. Ann Intern Med 2004 141 : 477 8.
12. Chalmers I. Underreporting research is scientific misconduct. JAMA 1990 263 : 1405 8.
13. The Rules Governing Medicinal Products in the European Union (Recommendation on the content of Trial Master File and archiving http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/v10_chap5.pdf Accessed 19 February 2007.
14. Moses H 3rd., Dorsey ER, Matheson DH, Thier SO. Financial anatomy of biomedical research. JAMA 2005 294 : 1333 42.
15. Califf RM. Clinical trials bureaucracy: unintended consequences of well-intentioned policy. Clin Trials 2006 3 : 496 502.
16. DAMOCLES Study Group. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet 2005 365 : 711 22.
17. The rules governing medicinal products in the European Union (Detailed guidance on the collection, verification and presentation of adverse events http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/ 21_susar_rev2_2006_04_11.pdf Accessed 19 February 2007.
18. The rules governing medicinal products in the European Union (Detailed guidance on the European database of suspected unexpected serious adverse reactions - Eudravigilance clinical trial module http://ec.europa.eu/enterprise/ pharmaceuticals/eudralex/vol-10/22_cp_and_guidance_database_susars16_april_2004. pdf Accessed 19 February 2007.
19. Chalmers I. Proposal to outlaw the term "negative trial". BMJ 1985 290 : 1002.
20. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001 357 : 1191 4.
21. Research Council UK (www.rcuk.ac.uk www.rcuk.ac.uk/news/ 20060628openaccess.htm Accessed 19 February 2007.
22. Medical Research Council (www.mrc.ac.uk www.mrc.ac.uk/PolicyGuidance/ EthicsAndGovernance/DataSharing/PolicyonDataSharingandPreservation/index.htm Accessed 19 February 2007.