PROTEUS Overview

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.

The PROTEUS Team is working with the Consortium partners to develop strategies for disseminating and implementing the PRO tools.

Organizations with PROTEUS participants*

The PROTEUS Consortium includes representatives from key patient, clinician, research, and regulatory groups from the U.S. and internationally who support the uptake and implementation of the PROTEUS Tools in practice:

  • AcademyHealth
  • American Cancer Society
  • American Society for Radiation Oncology
  • American Society of Clinical Oncology
  • Australian Clinical Trials Alliance
  • Canadian Association of Radiation Oncology
  • Cancer Australia
  • Consolidated Standards for Reporting of Trials (CONSORT)
  • Critical Path Institute PRO Consortium
  • European Medicines Agency-Scientific Advice Working Party Dutch Medicines Evaluation Board
  • European Organization for the Research and Treatment of Cancer
  • Food & Drug Administration
  • Health Canada
  • Industry (GlaxoSmithKline)
  • International Society for Quality of Life Research
  • medical journal editors
  • Medicines and Healthcare Products Regulatory Agency
  • National Cancer Institute
  • National Cancer Research Institute (UK)
  • National Clinical Trials Network
  • National Coalition for Cancer Survivorship
  • National Institute for Health and Care Excellence
  • Oncology Nursing Society
  • Patient-Centered Outcomes Research Institute
  • Society for Clinical Trials
  • Standard Protocol Items Recommendations for Interventional Trials (SPIRIT)

* Participation in PROTEUS does not imply endorsement of any particular PRO tools or guidance documents