CMTP’s Effectiveness Guidance Document (EGD) “Recommendations for Incorporating Patient-Reported Outcomes into the Design of Clinical Trials in Adult Oncology” is ready for your comments. The recommendations in it are intended to set a minimum standard to ensure that data collection allows for examination of patients’ directly reported experiences in diverse studies of treatment effectiveness and outcomes in oncology.
Since the 1990s, the assessment of patient-reported outcomes has become increasingly recognized as important for those treatment- and/or disease-related consequences that are directly experienced by patients such as symptoms and health-related quality of life (HRQOL). The importance of incorporating these outcomes into cancer research and policy formation has been emphasized by major policy-making, standard setting, and regulatory entities including the National Cancer Institute, the American Cancer Society, the US Food and Drug Administration, the U.S. Centers for Medicare & Medicaid Services, and the National Institutes of Health. Systematic collection of patient-reported outcomes in oncology reflects underlying health status more accurately than clinician reporting. Using patient-reported outcomes increases patient satisfaction with care, is valued by clinicians, and improves symptom management and patients’ overall health status. Moreover, patient self-reporting is the regulatory standard for assessing clinical endpoints in drug approval and labeling, as described in the FDA PRO Guidance document titled, “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.”
CMTP obtained input from stakeholders meeting held at its headquarters on this EGD on December 8, 2010. The EGD recommendations were put in their current form in April, 2011, and on May 24, 2011, the project team presented their recommendations at the ISPOR16th Annual International Meeting.
For more information, contact Merianne Spencer.