Analysis of 312 studies of investigational medicinal products in healthy subjects to assess the impact of the European Union Clinical Trials Directive

International Journal of Pharmaceutical Medicine

Volumn 16, Issue 4, 2002, Pages 179-183

  Boyce, Malcolm ^a   Warrington, Steve ^a  

^a CENTRAL MIDDLESEX HOSPITAL   (United Kingdom)

Author keywords

European Union Clinical Trials Directive; Expedited review; Healthy volunteers; Pharmaceutical Industry Competitiveness Task Force; Research ethics committees

Indexed keywords

DRUG;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG APPROVAL; DRUG CONTROL; DRUG INDUSTRY; DRUG RESEARCH; EUROPEAN UNION; HUMAN; MEDICAL ETHICS; METHODOLOGY; ORGANIZATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; UNITED KINGDOM; VOLUNTEER;

EID: 0036704281     PISSN: 13649027     EISSN: None     Source Type: Journal    
DOI: 10.1097/00124363-200208000-00005     Document Type: Article

References (17)

1. Medicines Act 1968. Guidance Notes on Applications for Clinical Trial Exemptions and Clinical Trial Certificates, May 2001. www.mca.gov.uk
2. Research on healthy volunteers. A report of the Royal College of Physicians. J R Coll Physicians Lond 1986; 20: 1-17.
3. Association of the British Pharmaceutical Industry. Guidelines for Medical Experiments In Non-Patient Volunteers. Association of the British Pharmaceutical Industry (ABPI); 1990.
4. Directive 2001/20/EC of the European Parliament and of the Council of the European Union 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. Off J Eur Comm 2001; L121: 34-44.
5. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Harmonised Tripartite Guideline for Good Clinical Practice, 1996. CPMP/ICH/135/95/Step5. www.emea.eu.int
6. Medicines Control Agency and Department of Health Briefing Note on the European Union Directive on Good Clinical Practice in Clinical Trials. www.mca.gov.uk
7. Central Office for Research Ethics Committees. Governance Arrangements for National Health Service Research Ethics Committees, July 2001. www.corec.org.uk
8. Pharmaceutical Industry Competitiveness Task Force. Department of Health and Association of the British Pharmaceutical Industry. Report of the Pharmaceutical Industry Competitiveness Task Force. Sections 6.9 and 6.22, March 2001.
9. O'Grady J, Joubert PH (editors). Handbook of Phase I/II Clinical Drug Trials, 2nd Edition. London: CRC Press; 1997.
10. Working party of the Royal College of Physicians. Clinical Pharmacology and Therapeutics in a Changing World. London: Royal College of Physicians; 1999.
11. Dollery CT. Pharmaceutical medicine and academic clinical pharmacology: A convergent pathway? Int J Pharm Med 2000; 14:33-36.
12. Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clin Pharmacol Ther 2001; 69:89-95.
13. Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. Off J Eur Comm 1975; L147: 13-22.
14. Medicines Control Agency. Rules and Guidance for Pharmaceutical Manufacturers and Distributors. Manufacture of Investigational Medicinal Products, Annex 13. London: MCA; 1997.
15. Frye RF, Matzke GR, Adedoyin A, Porter JA, Branch RA. Validation of the five-drug 'Pittsburgh cocktail' approach for assessment of selective regulation of drug-metabolising enzymes. Clin Pharmacol Ther 1997; 62:365-376.
16. Food and Drug Administration. GCP Regulations. Protection of Human Subjects: Code of Federal Regulations 21 CFR Part 56.110, April 2000. www.fda.gov
17. Walsh R. Recurrent non-compliance with GCP: An alternative perspective. Good Clin Pract J 2000; 7:11-14.