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
3. Provide an overview of the types of clinical studies performed during the product lifecycle, and describe the aspects of those studies that support the determination of which quality factors are critical to ensuring the protection of study subjects, 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 (Annex 2 and 3)
General principles of clinical study design 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 planning a clinical development programme, the types of studies and study objectives that are important at different points in the programme, and issues of study feasibility from the perspective of sponsors, investigators, regulatory authorities, and patients are ICH E8(R1) draft Guideline provided in Section 4. In Section 5, the elements composing study design are described. Section 6 describes study conduct, ensuring the safety of human subjects, and study reporting. A general discussion of identifying critical to quality factors for a study is provided in Section 7.
For the purposes of this document, a clinical study is meant to refer to a study of a medicinal product in humans, conducted at any point in a product’s lifecycle. The term “drug” should be considered synonymous with “medicinal product,” including vaccines and biological products. The term “drug approval” refers to obtaining marketing authorization for the drug