This is an umbrella guidance, and this update/modernization includes important concepts to support and implement other requirments, like quality risk management (from ICH E6). It introduces Quality by Design and Critical to Quality Factors, as appropriate and flexible tools and strategies to address the increasing diversity of study types and data sources that are currently used to support regulatory and other health policy decisions.
Clinical studies of medicinal products are conducted to provide information that can ultimately improve access to safe and effective products with meaningful impact on patients, while protecting those participating in the studies. This document provides guidance on the clinical development lifecycle, including designing quality into clinical studies, considering the broad range of clinical study designs and data sources used.
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 ensure the protection of study participants and 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
3. Provide an overview of the types of clinical studies performed during the product lifecycle, and describe study design elements that support the identification of quality factors critical to ensuring the protection of study participants, the integrity of the data, the reliability of results, and the ability of the studies to meet their objectives
4. Provide a guide to the ICH efficacy documents to facilitate user’s access General principles are described in Section 2 of this document, followed by a discussion of designing quality into clinical studies in Section 3. A broad overview of drug development planning and the information provided by different types of studies needed to progress development through the lifecycle of the product is given in Section 4. In Section 5, important elements of clinical study design are described that reflect the variety of designs used in drug development as well as the range of data sources available. Section 6 addresses study conduct, ensuring the safety of study participants, and study reporting. Some considerations for identifying factors that are critical to the quality of a study are provided in Section 7.
The ICH Efficacy guidelines are an integrated set of guidance covering the planning, design, conduct, safety, analysis, and reporting of clinical studies. ICH E8 provides an overall introduction to clinical development, designing quality into clinical studies and focusing on those factors critical to the quality of the studies. The guidelines should be considered and used in an integrated, holistic way rather than focusing on only one guideline or subsection.
For the purposes of this document, a clinical study is meant to refer to a study of one or more medicinal products in humans, conducted at any point in a product’s lifecycle, both prior to and following marketing authorisation. The focus is on clinical studies to support regulatory decisions, recognizing these studies may also inform health policy decisions, clinical practice guidelines, or other actions. The term “drug” should be considered synonymous with therapeutic, preventative, or diagnostic medicinal products. The term “drug approval” refers to obtaining marketing authorisation for the drug.