Document Detail


The impact of the 'Clinical Trials' directive on the cost and conduct of non-commercial cancer trials in the UK.
MedLine Citation:
PMID:  17118647     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The UK Medicines for Human Use (Clinical Trials) Regulations 2004 implemented the European 'Clinical Trials' Directive (2001/20/EC) (EUCTD) into UK law and came into effect on 1(st) May 2004. In the period leading up to the implementation of the EUCTD in the UK there were serious concerns that it would have major cost implications for academic units running non-commercial clinical trials. METHODS: Directors and senior staff in 8 Clinical Trials Units (CTUs) were contacted and invited to participate in the study; arrangements were made for face-to-face interviews and the units were sent a questionnaire in advance of the meeting. The questionnaire was divided into six sections covering their involvement in non-commercial cancer clinical trials, and their perceptions of the EUCTD and its impact on all stages of trial development and conduct. Detailed cost data were also collected. FINDINGS: The findings from the questionnaire and interviews indicate that the EUCTD has resulted in a doubling of the cost of running non-commercial cancer clinical trials in the UK and a delay to the start of trials. The lack of central guidance, lack of clarity regarding the interpretation of the guidance notes, and increase in essential documentation and paperwork were causes of major concern for experienced staff who were anxious about whether they were interpreting the Directive correctly. Moreover, the CTUs were unable or unwilling to open trials in non-UK centres because of the different interpretation of the EUCTD by member states. INTERPRETATION: The EUCTD has both increased the cost and caused delay to non-commercial cancer clinical trials run by major public sector Clinical Trials Units in the UK. Staff have felt that they were working beyond capacity and were feeling demoralised in many CTUs. Finally, rather than harmonising and simplifying the regulatory environment, the Clinical Trials Directive has stopped many units from running trials in international centres. The UK has taken action to address some of the problems identified by this and other research, but problems remain.
Authors:
J Hearn; R Sullivan
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2006-11-21
Journal Detail:
Title:  European journal of cancer (Oxford, England : 1990)     Volume:  43     ISSN:  0959-8049     ISO Abbreviation:  Eur. J. Cancer     Publication Date:  2007 Jan 
Date Detail:
Created Date:  2007-01-15     Completed Date:  2007-03-26     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  9005373     Medline TA:  Eur J Cancer     Country:  England    
Other Details:
Languages:  eng     Pagination:  8-13     Citation Subset:  IM    
Affiliation:
Clinical and Translational Research Directorate, Cancer Research UK, 61 Lincoln's Inn Fields, London, WC2A 3PX UK. Julie.hearn@cancer.org.uk
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MeSH Terms
Descriptor/Qualifier:
Attitude of Health Personnel
Clinical Trials as Topic / economics,  legislation & jurisprudence*,  methods
Costs and Cost Analysis
Europe
Great Britain
Humans
Medical Informatics
Neoplasms / economics*
Practice Guidelines as Topic
Questionnaires

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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