All Times EDT
Keywords: Estimands, Efficacy, Objectives
Draft Guidance for Industry E9(R1) outlines a stepwise process to develop trial protocols and associated statistical analysis plans. First, the objectives of the trial should be carefully specified. Then, to support those objectives, appropriate estimands should be detailed. While the draft guidance greatly clarifies how to specify estimands, it pays less attention to the particular task of ensuring alignment between estimands and clinical objectives. Here we will discuss the broad range of possible clinical objectives and a variety of estimands designed to align with each of those objectives. Our overall goal will be to develop a vocabulary to facilitate our collaborations with clinical and other colleagues to design statistical estimands which correspond to medical objectives.