The Food and Drug Administration designated 2016 as the Year of Diversity in Clinical Trials. At the time, less than 10 percent of trial participants were minorities...
ICH E6: Aspects of Risk-Based Thinking
The most prominent change to Section 5 of ICH E6 is the addition of Subsection 5.0 — Quality Management, in which ICH explains the principles of risk-based thinking in quality trial management...
