Our work to improve the quality and efficiency of clinical trials goes beyond the U.S. borders. Recently, CTTI conducted several efforts to help inform the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as it revises ICH E6 Good Clinical Practice (GCP):

• Through a global, multi-stakeholder survey with 327 research professionals from 154 countries, in-depth interviews, and a public open comment period, CTTI issued a report outlining the areas requiring the most focus pertaining to sponsors, essential documents, and investigators.
• CTTI also co-hosted a public event with the FDA to help the ICH in its efforts to improve various topics within GCP.
• On May 18 &19, CTTI convened two public web conferences hosted by the ICH that provided updates on the progress to revise this important and impactful guideline.