Impact assessment of the European Clinical Trials Directive: a longitudinal, prospective, observational study analyzing patterns and trends in clinical drug trial applications submitted since 2001 to regulatory agencies in six EU countries

Author:

Hartmann Markus

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Medicine (miscellaneous)

Reference37 articles.

1. Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, Schulman KA: Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009, 360: 816-823.

2. Thiers FA, Sinskey AJ, Berndt ER: Trends in the globalization of clinical trials. Nat Rev Drug Discov. 2008, 7: 13-14.

3. Directive 2001/20/EC of the European Parliament and the Council of 4 Apr 2001 on the approximation of 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 J Eur Community. 2001, L121: 34-44.

4. Frewer LJ, Coles D, Champion K, Demotes-Mainard J, Goetbuget N, Ihrig K, Klingmann I, Kubiak C, Lejeune SA, McDonald F, Apperley J: Has the European Clinical Trials Directive been a success?. BMJ. 2010, 340: 937-

5. European Commission - European Medicines Agency: Report on the Conference on the Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future. [ http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/11/WC500011204.pdf ]

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