FDA’s Quality by Design (QBD) Guidance for Clinical Trials
[Thursday, August 1, 2019]

The general quality expectations for clinical trials are described in a new ICH guidance adopted by the FDA this week. The concept of Quality-by-Design (QbD) has been the gold standard for defining quality expectations in manufacturing operations but similar standards lack for the conduct of clinical trials. It is generally accepted that the quality of clinical trial operations varies based on the sponsor, the clinical sites involved in trials, and the resources available with the sponsor. However, an equally important reason for lack of quality standards has been the lack of regulatory guidance on the expectations regarding quality clinical trial design and operations. The new guidance addressed this need. The guidance describes how QbD can be applied to clinical trials. It provides a holistic approach to clinical trial quality control starting from the design and planning to the conduct and analysis of clinical trials. It even highlights the relationship between clinical trials and other components of the clinical development programs such a non-clinical studies and manufacturing of the investigational product. Although many concepts described in the guidance document are also covered in various other guidance documents but this document does an essential role of connecting the pieces. While this would be certainly be very valuable read for new developers getting started on their first clinical trial, early stage regulatory and clinical trial professionals, it would also help everyone define the core quality standards for all clinical trial operations.