ICH E8 (General Considerations for Clinical Trials)

ICH E8 (General Considerations for Clinical Trials) provides international guidance on designing and conducting clinical trials safely and effectively. It emphasizes good planning, clear objectives, ethical standards, and participant safety. The document highlights the importance of proper trial design, consistent procedures, quality data collection, and compliance with regulations. Its goal is to ensure that clinical research produces reliable results that can be used to improve healthcare while protecting participants’ rights and well-being. Overall, ICH E8 promotes a systematic, ethical approach to developing new medicines and treatments through clinical studies.