International – ICH guideline E8 (R1) on general considerations for clinical studies : Step 2b

Clinical studies of medical interventions are conducted to provide information that can ultimately improve access to safe and effective drugs with meaningful impact on patients, while protecting those participating in the studies. This document focuses on designing quality into clinical studies, considering the diversity of clinical study designs and data sources used to support regulatory and other health policy decisions.

The ICH document « General Considerations for Clinical Studies » is intended to:

1. Describe internationally accepted principles and practices in the design and conduct of clinical studies that will facilitate acceptance of data and results by regulatory authorities

2. Provide guidance on the consideration of quality in the design and conduct of clinical studies across the product lifecycle, including the identification during study planning of factors that are critical to the quality of the study, and the management of risks to those factors during study conduct…