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 there are concerns that they have become vastly more complex and costly over the last 20 years