Quality control of oncology clinical trials.
This article discusses issues that are essential to ensuring the reliability of the conclusions of oncology clinical trials. Though quality control is important at every stage of a well-run clinical trial, the authors focus on the quality of the data as evidenced by the results and conclusions of the study. Good quality control principles and practices are discussed for study planning, design, conduct, analysis, and interpretation.
Meyerson
L J
LJ
Department of Biostatistics, Quintiles, Inc., Kansas City, Missouri, USA.
Wiens
B L
BL
LaVange
L M
LM
Koutsoukos
A D
AD
D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D003625:Data Collection; D017277:Drug Approval; D004345:Drug Industry; D004363:Drug Utilization; D005568:Forms and Records Control; D006077:Government Agencies; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D018579:Patient Selection; D011786:Quality Control; D015203:Reproducibility of Results; D012107:Research Design; D012449:Safety; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration