When sitting with a patient—or as a patient—deciding whether to start a treatment, often the first question asked is, “how will it make me feel” or “how have others like me felt.” Yet this information is conspicuously absent from most US drug labels and published results of regulatory clinical trials.

The guiding principle here is that the patient perspective, which is usually best captured via a patient-reported outcome (PRO) measure, is always relevant and should be assessed in all pivotal clinical trials unless the impact of a product on the patient experience is already well known. Even if a product is expected to have little or no impact on how a patient feels, substantiating that expectation with data is informative to decision makers. Patient-reported information may reflect symptomatic benefits or symptomatic toxicities of a product or may demonstrate impact on the overall patient experience measured as health-related quality of life (HRQOL). Arguably, not including such information in a trial or label represents an omission that results in decision makers having incomplete information to balance risks with benefits.

Why is this information so often missing from labels? Is it that sponsors simply do not measure patients' symptoms or HRQOL? Or perhaps sponsors do collect this information but the Food and Drug Administration (FDA) feels their approaches are methodologically inadequate to merit inclusion in labels? Or maybe it is overly challenging or infeasible to collect and analyze patient reports compared with survival-based or surrogate end points.

An informative new article in the current issue of Value in Health [1] provides descriptive data suggesting that all the above reasons may contribute, but, as described below, are surmountable.