Clinical study design

Abstract The clinical trial is a tool that most breath researchers will use at some point to address a scientific question. Each clinical study requires a bespoke design that is tailor-made to address the specific study objective(s). As such, this chapter does not list suggested designs, but rather provides a three-step approach toward designing a bespoke trial. Firstly, a framework is provided to help set realistically achievable and useful objectives and subsequently define minimum requirements to address these. The next step is to list constraints within which to operate, as well as specific strengths that can be leveraged. This provides a clear framework for the actual step of designing the study and maximizing its chances of success. This includes considerations on the relevance of understanding clinical utility, applying appropriate quality controls, and performing independent multicenter validation. Research is currently filled with examples of bad trial design that limits the progress of this important field of study toward clinical practice. Adhering to the framework outlined in this chapter will aid in preventing some of the common pitfalls.