title: Current status of patient-reported outcomes in industry-sponsored oncology clinical trials and product labels.
abstract: Assessing patient-reported outcomes (PROs) in clinical trials is of interest to clinicians, patients, regulators, and industry. The use and impact of PROs is a growing area of methodologic research, particularly as they relate to tumor types, biomarkers, and various patient populations and cultures. Both the US Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products in recent guidance have acknowledged the need to account for treatment-related impact on patient symptoms and/or health-related quality of life (HRQOL). Clinical research likely reflects the informative value of PROs. A search of www.clinicaltrials.gov, the FDA Web site, and product package inserts was conducted to assess the inclusion of symptom assessment and HRQOL within industry-sponsored clinical trials in cancer and approved cancer therapies and their respective product labels. Overall, there were 2,704 industry-sponsored oncology trials, of which 322 (12%) included a PRO measure. Of the 70 FDA new or revised labels, only six package inserts include PRO data. Symptoms were assessed uniformly across the phases of clinical trials, whereas HRQOL assessment increased in the later phases of clinical trials. Collecting PRO data can enhance our understanding of cancer burden and the impact of interventions on patients' lives.
authors.affiliation: Bayer Corporation, West Haven, CT 06516, USA. kathleen.gondek@bayer.com
authors.forename: Kathleen
authors.initials: K
authors.lastname: Gondek
authors.forename: Pierre-Philippe
authors.initials: PP
authors.lastname: Sagnier
authors.forename: Kim
authors.initials: K
authors.lastname: Gilchrist
authors.forename: J Michael
authors.initials: JM
authors.lastname: Woolley
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004345:Drug Industry; D004348:Drug Labeling; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D017060:Patient Satisfaction; D019984:Quality Indicators, Health Care; D011788:Quality of Life; D018434:Sickness Impact Profile; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents