PMID- 23715997
OWN - NLM
STAT- MEDLINE
DCOM- 20140218
LR  - 20211021
IS  - 1432-1750 (Electronic)
IS  - 0341-2040 (Linking)
VI  - 191
IP  - 4
DP  - 2013 Aug
TI  - Reporting trends of outcome measures in phase II and phase III trials conducted 
      in advanced-stage non-small-cell lung cancer.
PG  - 313-9
LID - 10.1007/s00408-013-9479-z [doi]
AB  - 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.
FAU - Ghimire, Saurav
AU  - Ghimire S
AD  - Department of Clinical Pharmacy, College of Pharmacy, Chungnam National 
      University, Daejeon, 305-764, South Korea.
FAU - Kyung, Eunjung
AU  - Kyung E
FAU - Kim, Eunyoung
AU  - Kim E
LA  - eng
PT  - Journal Article
DEP - 20130530
PL  - United States
TA  - Lung
JT  - Lung
JID - 7701875
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Carcinoma, Non-Small-Cell Lung/mortality/pathology/*therapy
MH  - Chi-Square Distribution
MH  - Child
MH  - Child, Preschool
MH  - Clinical Trials, Phase II as Topic/*trends
MH  - Clinical Trials, Phase III as Topic/*trends
MH  - Disease Progression
MH  - Disease-Free Survival
MH  - Endpoint Determination/*trends
MH  - Female
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Lung Neoplasms/mortality/pathology/*therapy
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Quality of Life
MH  - Registries
MH  - Research Design/*trends
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2013/05/30 06:00
MHDA- 2014/02/19 06:00
CRDT- 2013/05/30 06:00
PHST- 2013/01/24 00:00 [received]
PHST- 2013/05/09 00:00 [accepted]
PHST- 2013/05/30 06:00 [entrez]
PHST- 2013/05/30 06:00 [pubmed]
PHST- 2014/02/19 06:00 [medline]
AID - 10.1007/s00408-013-9479-z [doi]
PST - ppublish
SO  - Lung. 2013 Aug;191(4):313-9. doi: 10.1007/s00408-013-9479-z. Epub 2013 May 30.