US Food and Drug Administration (FDA) officials on Monday morning held a meeting to offer a rundown of what needs to be done and what to expect from more than a dozen different International Council for Harmonisation (ICH) guidelines.
Kicking off the three-hour meeting, hosted alongside Health Canada, three FDA experts and Lisa LaVange, professor of biostatistics at the University of North Carolina, discussed topics that recently reached Step 3 of the ICH process. The ICH Assembly’s next two meetings are in Amsterdam in June and Singapore in November.
LaVange discussed E8(R1), which is a revised guideline on general considerations for clinical trials and part of a broader good clinical practice (GCP) renovation, which includes adopting a quality-by-design framework for clinical studies, and expanding the guideline’s scope to include a broader range of study designs and data sources.
She said the expert working group (EWG), which has met three times in person and held multiple conference calls, wanted to make sure the guideline is pertinent in today’s world, where there are a variety of clinical trial designs and the ability to use more real-world data sources, including electronic health records. She also noted that the EWG joked about renaming this guideline E0 “because it should come before all the other guidelines.”
The guideline is expected to reach Step 2b in early May 2019 and be issued for public consultation. A public meeting on the topic at FDA is slated for November, and finalization as a Step 4 document is planned for June 2020…