The International Conference on Harmonisation’s (ICH) Good Clinical Practice (GCP) guideline (E6) is ripe for review, according to the vast majority of respondents to a members’ poll by the UK-based Institute of Clinical Research (ICR).

The E6 guideline was introduced in 1996 and has never been updated, despite “developments in clinical research moving on at some pace” in the interim, the ICR noted. Other important guidelines in the field, such as the Declaration of Helsinki, have been revised a number of times over the last decade.

Picking up on a remark by a speaker at the Institute’s annual conference earlier this year, the ICR conducted an online survey of its members to see whether they felt the ICH guideline should now be reviewed and potentially revised. The result was that 84% of respondents confirmed they would like to see the first set of revisions to the guideline since implementation.

While ICR members believed some areas of ICH E6 should remain unchanged, as they were still relevant to clinical research today, a number of respondents also suggested areas that warranted review. These included harmonisation and globalisation, clarifications and interpretation, scientific developments, data protection and essential documents.

“Although the ICH GCP guidelines don’t have any direct legal status in the legislation of all countries where clinical research is conducted, their principles set the tone for how most people conduct clinical research,” noted Sue Fitzpatrick, education manager at ICR.

The Institute did acknowledge that revising ICH E6 would present a significant challenge, given the evolution of, and variations in, associated national legislation as well the number of stakeholders involved.