Consideration Documents
- Work Products
Consideration documents are documents developed by discussion groups i.e., Gene Therapy Discussion Group (GTDG), and ICH & Women Discussion Group. These documents reporting specific scientific considerations do not require the formal ICH approval procedure, but do require discussion and endorsement by the ICH Assembly.
Gene Therapy Discussion Group
In September 2002 the ICH Steering Committee established a Gene Therapy Discussion Group (GTDG) in recognition of the rapidly evolving area of gene therapy medicinal products. The GTDG developed several ICH Consideration documents in the area of gene therapy which can be found below. In September 2011, after extensive SC discussion that currently the ICH regions do not have the resources to support the development of further ICH consideration documents, the development of these considerations papers was discontinued.
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ICH Considerations:
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ICH and Women
At the Steering Committee (SC) meeting held in November 2003, the SC agreed to establish an Informal Discussion Group to assess the adequacy of current ICH guidance concerning the participation of women in clinical trials.
In November 2004, the Informal Discussion Group presented the SC with the results of surveys undertaken in the three ICH regions which confirmed that women are, in general, adequately represented in trial populations. Since the findings did not support development of a separate ICH Guideline on women, the outcome of the surveys, including the review of existing ICH Guidelines and regional experiences were reported in an ICH Considerations document which was posted on the ICH website.
In Yokohama, in June 2009, the Considerations document was updated to include reference to relevant new and revised ICH Guidelines and to reflect the recognised distinction between the concepts sex and gender.
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ICH Considerations:
