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Call for updated clinical practice guidance

Poll shows 80 per cent of ICR members want International Conference on Harmonisation Good Clinical Practice guidelines to be revisited

An online poll carried out by the Institute of Clinical Research (ICR) has revealed that more than 80 per cent of its members would like the International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines to be revisited.

In the survey, carried out via the ICR website, 84 per cent of respondents confirmed that they would like to see the first set of revisions to the ICH GCP guidelines since their implementation 13 years ago.

Though there have been many developments in clinical research since ICH GCP was introduced in 1996, the guidelines have never been updated. Other guidelines, such as the Declaration of Helsinki, have been revised several times during the past decade.

Sue Fitzpatrick Hon FICR CSci, education manager at ICR, commented:  "Although the ICH GCP guidelines don't have any direct legal status in the legislation of all countries where clinical research is conducted, its principles set the tone for how most people conduct clinical research."

Within the survey, a number of members gave suggestions of the areas that could be reviewed should a revision take place. These included: harmonisation and globalisation; clarifications and interpretation; scientific developments; data protection and essential documents.

Sue added: "The opinion expressed by our members was that some areas of ICH GCP should remain unchanged as they are still very relevant to clinical research today, however, certain amendments would be welcomed and would ensure the guidelines are still meeting the needs of the industry."

The ICR is an international professional clinical research body.

9th September 2009

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