The International Council on Harmonization (ICH) and the World Health Organization (WHO) recently released draft versions of two important international guidelines on best practice for clinical trials. Both documents will take effect in 2024.
1. ICH E6(R3) Guideline for Good Clinical Practice (GCP) DRAFT
This is a major update to the international standards for conducting clinical trials of investigational products. This revised guideline aims to address the opportunities and challenges of applying GCP principles to the increasing diverse trial types, data sources and technological innovations used to support regulatory in healthcare-related decision-making on products.
2. WHO guidance for best practices for clinical trials DRAFT
Also known as “WHO GCP”. This guideline provides key principles, as well ass scientific and ethical considerations for well-designed clinical trials. It also suggests ways to strengthen the clinical trials ecosystem and improve the quality and diversity of clinical trials around the world.
Join us in a four-part lunch series to cover these important draft documents and discuss their expected impact on design, practices and conduct of clinical trials in British Columbia, Canada and internationally.