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The endpoint typically used to measure the effectiveness of a cancer treatment in clinical trials is whether the intervention helps patients live longer. As new therapies lead to a growing number of cancer survivors and patients increasingly receive multiple treatments, the use of survival as an endpoint has become problematic because it can be difficult to accurately determine the specific impact of each intervention. Consequently, other reliable endpoints are needed, and researchers have sought patient input in developing other measures of clinical benefit, including patient-reported outcomes (PRO) related to quality of life.

More than 200 researchers joined representatives from the health care industry, patient advocacy organizations, and government to discuss the evolving field of PRO at the September 20-21 PRO Assessment in Cancer Trials (PROACT) conference. NCI's Division of Cancer Control and Population Sciences, Division of Cancer Prevention, and Division of Cancer Treatment and Diagnosis (DCTD) cosponsored the conference with the American Cancer Society.

Conference goals included identifying when, where, and how PRO assessment brings significant value to a clinical trial; developing guidelines for PRO assessment and data collection; identifying research studies and application projects that would improve health-related quality of life (HRQOL) and symptom measurement in cancer clinical trials; and identifying issues for implementing PRO research in NCI-sponsored clinical trials, including those addressed by NCI's Clinical Trials Working Group (CTWG).

CTWG developed a plan to restructure NCI clinical trials around new and effective priorities. Dr. James Doroshow, CTWG chair and DCTD director, noted that CTWG's plan included a focus on symptom management and HRQOL. "NCI is committed to supporting research in symptom management and health-related quality of life," he said.

With representation from the cancer community, CTWG's Symptom Management and HRQOL Steering Committee will identify the resources needed to support PRO measures in national treatment trials in which NCI has a role. Dr. Doroshow said he expects the steering committee to have a strong influence on the criteria NCI uses to review quality-of-life studies, as well as on the PRO aspects of many trials conducted by the cooperative groups and community oncology programs. The first steering committee meeting will take place in the spring of 2007.

At the PROACT conference, the application and value of symptom and HRQOL data in NCI-sponsored phase I, II, and III treatment and symptom management trials were explored through in-depth case studies. Both learning opportunities and instances in which PRO yielded valuable information for decisions about cancer care, third-party payment, and drug approval were identified.

Based upon these case studies, conference participants began to identify best practices for using PRO measures to ensure that the most important HRQOL studies can be incorporated quickly into NCI-sponsored trials.

Conference presentations will be available in the near future at: http://outcomes.cancer.gov.