ASCPRO (Assessing the Symptoms of Cancer using Patient-Reported Outcomes) is part of an evolving reconsideration of patient-reported outcomes in clinical trials. ASCPRO was formed in response to the issuance by the U.S. Food & Drug Administration of its guidelines for "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims." The impact of the guidance on the development of outcomes for clinical research is enormous and is of high interest to those who sponsor and conduct clinical research, including the National Institutes of Health, industry, and academic researchers, and to those who are consumers of this research, including regulators, health care providers, and patients.

ASCPRO is one of several groups, such as the Mayo Clinic, the International Society for Quality of Life Research, and the International Society for Pharmacoeconomics and Outcomes Research, that are reviewing the FDA guidance and commenting on the multiple methodological issues raised therein. ASCPRO focuses specifically on cancer-related symptoms, a significant area for new drug development and therapy benefit assessment.

Symptoms are an important domain within patient-reported outcomes, especially for patients with cancer. Some have concluded that, because patient reports of symptoms have long been accepted as outcomes for both curative and symptom interventions, there is less need to devote time to discussing the best way to measure them. However, many measurement issues need to be identified and addressed, and these issues will be the focus of our meetings.