Clinical Trial Evolution: The Drive to Update ICH E6

The ICH E6 guidelines has set the clinical trial industry standard since it was first published in 1996. As clinical trials and technologies, however, continue to rapidly evolve, there is a need for these guidelines to shift as well. The industry has called for a revision of the ICH E6 (R2) guidelines to spotlight risk-based monitoring and allow for more flexibility to adapt to future needs and progress.