New EU clinical trials regulation: Needs a few tweaks before implementation

BMJ (Online)

Volumn 348, Issue , 2014, Pages

  Westra, Anna E ^a   Bos, Wendy ^a   Cohen, Adam F ^b  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b CENTRE FOR HUMAN DRUG RESEARCH   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ACCREDITATION; EDITORIAL; EUROPEAN UNION; GOVERNMENT REGULATION; HUMAN; MEDICAL ETHICS; MEDICAL RESEARCH; MEDICAL SOCIETY; MEDICOLEGAL ASPECT; PRIORITY JOURNAL; RESEARCH SUBJECT; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK FACTOR; TOTAL QUALITY MANAGEMENT;

CLINICAL TRIALS AS TOPIC; ETHICS COMMITTEES, RESEARCH; EUROPEAN UNION; HUMAN EXPERIMENTATION; HUMANS;

EID: 84902184222     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.g3710     Document Type: Editorial

References (11)

1. European Parliament. Clinical trials: clearer rules, better protection for patients. 2014. www.europarl.europa.eu/news/en/news-room/content/ 20140331IPR41186/html/Clinical-trials-clearer-rules-better-protection-for- patients.
2. 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 Journal of the European Communities 1.5.2001: L121/34-L121/44. www.eortc.be/services/doc/clinical-eu-directive-04-april-01. pdf.
3. European Commission. Assessment of the functioning of the "Clinical Trials Directive" 2001/20/EC. Public consultation paper. 2009. http://ec.europa.eu/health/files/clinicaltrials/docs/2009-10-09-public- consultation-paper.pdf.
4. European Commission. Assessment of the functioning of the "Clinical Trials Directive" 2001/20/EC. Summary of responses to the public consultation paper. 2010. http://ec.europa.eu/health/files/clinicaltrials/2010- 03-30-summary-responses.pdf.
5. European Commission. Revision of the "Clinical Trials Directive." Concept paper submitted for public consultation. Brussels: European Commission, 2011. http://ec.europa.eu/health/files/clinicaltrials/ concept-paper-02-2011.pdf.
6. European Commission. Revision of the "Clinical Trials Directive." Summary of the replies to the public consultation on the "Concept paper." 2011. http://ec.europa.eu/health/files/ clinicaltrials/ctresp-2011-06/ct-summary.pdf.
7. Tuffs A. Germany opposes EU plans for regulating clinical trials owing to lack of ethical standards. BMJ 2012; 345:e6640.
8. Hasford J. New European Union regulation of clinical trials puts trial participants at risk. BMJ 2013; 346:f665.
9. Council of the European Union. Proposal for a regulation of the European Parliament and of the council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. 2013. http://ec.europa.eu/health/ files/clinicaltrials/2012-07/proposal/2012-07-proposal-en.pdf.
10. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000; 283: 2701-11. (Pubitemid 30337334)
11. Kenter MJH, Cohen A. Re-engineering the European Union Clinical Trials Directive. Lancet 2012; 379: 1765-7.