The need for proportionate regulation of clinical trials

The Lancet Oncology

Volumn 14, Issue 6, 2013, Pages 454-455

  Kearns, Pamela ^a  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL PRACTICE; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); DRUG LABELING; DRUG LEGISLATION; EUROPEAN UNION; FUNDING; HEALTH ECONOMICS; HUMAN; HUMAN RIGHTS; LETTER; LICENSING; MEDICAL DECISION MAKING; PRIORITY JOURNAL; RESPONSIBILITY; SAFETY;

ACCESS TO INFORMATION; CLINICAL TRIALS AS TOPIC; COOPERATIVE BEHAVIOR; DRUG APPROVAL; EUROPE; EUROPEAN UNION; GOVERNMENT REGULATION; HEALTH POLICY; HUMANS; INTERNATIONAL COOPERATION;

EID: 84876969202     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(13)70077-9     Document Type: Letter

References (7)

1. Hearn J, Sullivan R The impact of the 'Clinical Trials' directive on the cost and conduct of non-commercial cancer trials in the UK. Eur J Cancer 2007, 43:8-13.
2. Lambers Heerspink HJ, Dobre D, Hillege HL, Grobbee DE, de Zeeuw D Does the European clinical trials directive really improve clinical trial approval time?. Br J Clin Pharmacol 2008, 66:546-550.
3. Hartmann M 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. Trials 2012, 13:53.
4. Gulland A Number of global clinical trials done in UK fell by two thirds after EU directive. BMJ 2009, 338:b1052.
5. Mitchell C Clinical trials in paediatric haematology-oncology: are future successes threatened by the EU directive on the conduct of clinical trials?. Arch Dis Child 2007, 92:1024-1027.
6. Hoey R The EU Clinical Trials Directive: 3 years on. Lancet 2007, 369:1777-1778.
7. 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 2012, European Commission, European Commission, Brussels.