ICH To Fix Inconsistencies With RCTs, Address Use Of Alternate Designs And Data Sources
The International Council for Harmonisation has proposed major changes to its good clinical practice requirements in a bid to allay concerns about the problems they pose in conducting well-designed randomized trials. The revised GCP framework would also address the increasing diversity of clinical trial designs and data sources.
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The meeting will allow the International Council for Harmonisation to further discuss the concerns non-ICH members have over its guideline that covers general considerations for clinical trials.
The International Council for Harmonisation appointed more observers at its latest meeting in Amsterdam and identified several new topics on which it plans to issue harmonized guidelines.
The International Council for Harmonisation has proposed modernizing its July 1997 guideline on general considerations for clinical trials. The proposal also kick-starts the GCP renovation project, which aims to remove inconsistencies in how randomized control trials are conducted.