The Research Question and the Hypothesis

Abstract

Clinical trial design starts with the development of a focused, concise, answerable primary research question. The time spent defining this question up front is as valuable as the time that will be spent conducting the trial itself. Start simple with real ideas that are meaningful to your clinical practice and specialty. Refine your ideas into a more defined research question. This research question needs to be relevant, needs to translate to the primary hypothesis to be tested, needs to set the steps in motion to define the research methodology and analytic plan for the trial, needs to be answerable, and ultimately needs to offer promise that this answer will provide critical new knowledge that will change clinical practice for the better and improve patient outcomes.