Patients and clinicians value information about the impact of disease and treatment from the perspective of patients, so patient-reported outcome (PRO) assessments are a critical aspect of clinical trials. To be useful, PROs must be measured appropriately and reported clearly. Tools to improve the assessment and interpretation of PROs in clinical trials have been developed. Optimizing the use of PROs requires a coordinated and stakeholder-driven implementation and dissemination strategy to ensure that the tools are fully applied in practice.
The PROTEUS Consortium has been formed with the primary goal of ensuring that patients, clinicians, and other decision-makers have PRO data from clinical trials to make the best decisions they can about treatment options. To accomplish this goal, the PROTEUS Consortium is partnering with key patient, clinician, research, and regulatory groups from the U.S. and internationally to promote systematic use of the methodologic tools in clinical trials. These tools were developed to optimize the design, analysis, reporting, and interpretation of PROs in clinical trials.
* Participation in PROTEUS does not imply endorsement of any particular PRO tools or guidance documents