International Conference for Harmonization is going to implement substantial amendments into Good Clinical Practice (GCP) guidelines, and a letter of this intention has been published on ICH official website recently.
ICH and industry both got plenty of experience in clinical trial’s planning and conduct since GCP guidelines were released. The organization states that new set of recommendations will contain new detailed advice on several issues.
As a first step, ICH is going to revise and update ICH E8 (General Considerations for Clinical Trials) guidance. ICH will identify quality parameters, aspects of a trial that are critical to generating reliable data (e.g., relevant critical-to-quality [CTQ] factors) and will offer strategies to support quality of a study.
ICH E6 (GCP) guidance will also be revised after amendments to ICH E8 are made. The current approach to clinical trial conduct is not going to change, but it is proposed to be supplemented with several annexes. New quality requirements from proposed ICH E8 will be implied in E6. These requirements will be based on the experience of major regulators, such as EMA and FDA. Approach to traditional interventional clinical trials will not change but will be revised in accordance with recent experience. A new set of recommendations on non-traditional interventional studies and recommendations on data obtained from alternative sources (for example, electronic health records) will be released, approaches to protocol compliance and safety assessment will also be designed.
Amendments will be made to ICH E8 first – new guidance is going to be issued in late 2017 or in early 2018. ICH considers providing a 30-day public comment period for receiving comments from industry. After that ICH is going to meet with public stakeholders to discuss further steps.