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ICH To Fix Inconsistencies With RCTs, Address Use Of Alternate Designs And Data Sources

 
• By Vibha Sharma

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.

GCP
ICH's revised GCP proposal is expected to address the increasing diversity of clinical trial designs and data sources. • Source: Shutterstock

A proposal by the International Council for Harmonisation to “renovate” its guidance on good clinical practice requirements will look at ways to remove inconsistencies in how traditional randomized interventional trials are conducted and explore how to make use of non-traditional trial designs and data sources, such as real world data.

Randomized trials have traditionally been regarded as the most reliable way to assess the safety and effectiveness of treatments. But...

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