title: Reporting trends of outcome measures in phase II and phase III trials conducted in advanced-stage non-small-cell lung cancer.
abstract: BACKGROUND
  The methodology of conducting clinical trials in lung cancer has been challenged by the particular characteristics of new targeted agents. Thus, the choice of correct outcome measures and selection of best study designs are essential. We assessed the trends in reporting of outcome measures in phase II and phase III trials conducted in advanced non-small-cell lung cancer (NSCLC) patients.
  
  
  METHODS
  Data from September 2000 to September 2012 were extracted from the ClinicalTrials.gov database, and a descriptive-comparative analysis was performed to evaluate outcome-measures reporting for the two phases.
  
  
  RESULTS
  We identified 459 phase II and 128 phase III trials that met our inclusion criteria. The frequently reported primary outcomes in phase II trials were progression-free survival (PFS; 32%), response rate (RR; 21.4%), and safety and toxicity (adverse events [AEs]; 14.6%). In contrast, overall survival (OS; 60.9%) and PFS (26.6%) were frequently reported primary outcomes in phase III trials. AEs were reported as a secondary outcome measure in 50.1 and 64.8% of phase II and phase III trials, respectively. Improvement in quality of life was identified as a secondary outcome measure significantly more frequently in phase III than in phase II trials.
  
  
  CONCLUSIONS
  Our study identified recent trends in reports of outcome measures in advanced-stage NSCLC phase II and phase III trials. The outcomes of this study can be valuable for investigators with minimal or some experience in the field of oncology who are conducting clinical research.
authors.affiliation: Department of Clinical Pharmacy, College of Pharmacy, Chungnam National University, Daejeon, 305-764, South Korea.
authors.forename: Saurav
authors.initials: S
authors.lastname: Ghimire
authors.forename: Eunjung
authors.initials: E
authors.lastname: Kyung
authors.forename: Eunyoung
authors.initials: E
authors.lastname: Kim
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D017322:Clinical Trials, Phase II as Topic / Q000639:trends*; D017326:Clinical Trials, Phase III as Topic / Q000639:trends*; D018450:Disease Progression; D018572:Disease-Free Survival; D023381:Endpoint Determination / Q000639:trends*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011788:Quality of Life; D012042:Registries; D012107:Research Design / Q000639:trends*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult