Quality control of oncology clinical trials

Hematol Oncol Clin North Am. 2000 Aug;14(4):953-71, x. doi: 10.1016/s0889-8588(05)70321-x.

Abstract

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.

Publication types

  • Comparative Study
  • Review

MeSH terms

  • Clinical Trials as Topic / methods
  • Clinical Trials as Topic / standards*
  • Data Collection
  • Drug Approval
  • Drug Industry
  • Drug Utilization
  • Forms and Records Control
  • Government Agencies
  • Humans
  • Neoplasms / drug therapy
  • Neoplasms / mortality
  • Neoplasms / therapy*
  • Patient Selection
  • Quality Control
  • Reproducibility of Results
  • Research Design
  • Safety
  • Time Factors
  • Treatment Outcome
  • United States
  • United States Food and Drug Administration