A Survey of Danish, German and Spanish Ethics Committees Prior to the 2004 Implementation of the European Directive Covering the International Conference of Harmonisation − Good Clinical Practices (ICH-GCP)

Authors: Revuelta, Javier¹; Jimenez, Nicolas V.¹; Portoles, Antonio²; Lardinois, Rene³

Source: International Journal of Pharmaceutical Medicine, Volume 19, Number 1, 2005 , pp. 29-36(8)

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Abstract:

Objective and methods: In January 2000, a written questionnaire was provided to ethics committees in Denmark, Germany and Spain in order to collect information on the main characteristics and percentages of committees fulfilling Good Clinical Practices (GCP) in accordance with the International Conference of Harmonisation (ICH) guidelines. The committees were also asked to outline their clinical trial-related activities throughout 1999.

Results and conclusions: In the pool of 169 committees, 43.8% answered the questionnaire and gave data on 80.7% of the questions put to them. The rate of adherent committees showing compliance to GCP guidelines was between 62.5% and 100% with respect to procedures and archiving. In contrast, the survey revealed many shortcomings among the committees (ongoing supervision of authorised clinical trials in terms of patient recruitment, serious adverse reactions, audit results, investigators' meetings and emerging problems during study development), investigators (failure to provide update reports to the committee) and sponsors (only 38.2% of their protocols were approved after the first examination; final reports were often not provided to the committees). However, in terms of GCP adherence required by the 2001 EU clinical trials directive, marked differences in the rates of compliant committees were observed among the three European countries. As the EU clinical trials directive comes into force, some committees will have to implement only minor changes to their working activities, while others will have to make profound changes or even interrupt their activities.@SUMMARY TEXT2 =

Keywords: Ethics; Regulatory process

Document Type: Research article

Affiliations: 1: 1 Department of Pharmacy, University of Valencia, Valencia, Spain 2: 2 Hospital Clínico San Carlos, Madrid, Spain 3: 3 Madrid, Spain

Publication date: 2005-01-01

A Survey of Danish, German and Spanish Ethics Committees Prior to the 2004 Implementation of the European Directive Covering the International Conference of Harmonisation − Good Clinical Practices (ICH-GCP)

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