title: Evaluation of health-related quality-of-life measures in oncology drug product applications: issues and concerns.
abstract: Health-related quality-of-life outcomes as reported by patients are valuable data and ideally should be critical to evaluating clinical benefit. The unblinded or open-label designs commonly adapted in oncology trials have the potential to introduce selection bias, reporting bias, and analyses bias. In this paper, issues surrounding use of patient reported outcomes to evaluate oncology drug products, including definition of hypothesis, study design, analysis, and interpretation of patient reported outcome data, are reported.
authors.affiliation: Division of Biometrics 1, HFD-710, Office of Biostatistics, The Food and Drug Administration, Rockville, Maryland 20857, USA. sridharar@cder.fda.gov
authors.forename: Rajeshwari
authors.initials: R
authors.lastname: Sridhara
authors.forename: Gang
authors.initials: G
authors.lastname: Chen
authors.forename: George Y H
authors.initials: GY
authors.lastname: Chi
authors.forename: Donna J
authors.initials: DJ
authors.lastname: Griebel
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods* / Q000706:statistics & numerical data; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods* / Q000706:statistics & numerical data; D006262:Health; D006801:Humans; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents