Effect of European Clinical Trials Directive on academic drug trials in Denmark: Retrospective study of applications to the Danish Medicines Agency, 1993-2006

BMJ

Volumn 336, Issue 7634, 2008, Pages 33-35

  Berendt, Louise ^a,c   Håkansson, Cecilia ^a,c   Bach, Karin Friis ^b   Dalhoff, Kim ^c,d   Andreasen, Per Buch ^b   Petersen, Lene Grejs ^a   Andersen, Elin ^a   Poulsen, Henrik Enghusen ^c,d  

^a DANISH MEDICINES AGENCY   (Denmark)

^b GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^c University of Copenhagen   (Denmark)

^d UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PRACTICE; DENMARK; EUROPE; MEDICAL LITERATURE; MEDICAL RECORD REVIEW; MEDICAL RESEARCH; PRIORITY JOURNAL; RETROSPECTIVE STUDY; UNIVERSITY; CLINICAL TRIAL; DRUG APPROVAL; EUROPEAN UNION; GOVERNMENT; STATISTICS;

NEW DRUG;

CLINICAL TRIALS AS TOPIC; DENMARK; DRUGS, INVESTIGATIONAL; EUROPEAN UNION; GOVERNMENT AGENCIES; INVESTIGATIONAL NEW DRUG APPLICATION; RETROSPECTIVE STUDIES;

EID: 38149018609     PISSN: 09598146     EISSN: None     Source Type: Journal    
DOI: 10.1136/bmj.39401.470648.BE     Document Type: Article

References (6)

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. Official J Eur Commun 2001;L121:34-44.
2. Hemminki A, Kellokumpu-Lehtinen PL. Harmful impact of EU clinical trials directive. BMJ 2006;332:501-2.
3. Mayor S. Squeezing academic research into a commercial straitjacket. BMJ 2004;328:1036.
4. Morice AH. The death of academic clinical trials. Lancet 2003;361:1568.
5. European Commission. European clinical trials database. http://eudract.emea.europa.eu.
6. Singer E. Future of investigator initiated trials in EU academia. [Abstract.] Basic Clin Pharmacol Toxicol 2007;101(suppl 1):11.