Capturing patients' perspectives of treatment in clinical trials/drug development.

The patient's perspective of treatment outcomes is increasingly important to consumers and providers of healthcare. Recent studies have shown that traditional clinical endpoints may not accurately reflect the patient experience with treatment. Often patients' experience of their disease and associated treatment differs from the perspective of their physicians. When implemented with a clear and effective assessment strategy, patient-reported outcome (PRO) measures can be used to collect data directly from patients in the clinical setting. These data can be applied to a range of outcomes, such as treatment efficacy, safety, and patient satisfaction. Such information is valuable at various stages of drug development and can be used to understand the patient's perspective of the treatment for evaluating the treatment benefit of new products and to engage patients to make decisions about treatment options and ultimately to support commercialization of pharmaceutical products. Recognizing the value of these data, various regulatory agencies have recently released guidelines on how to best implement these measures in clinical trials to support label claims. The purpose of this paper is to discuss the benefits of collecting PRO data for evaluating the outcomes of treatments in clinical trials, through the product life cycle.