Pain palliation measurement in cancer clinical trials: The US Food and Drug Administration perspective Academic Article uri icon

Overview

MeSH Major

  • Clinical Trials as Topic
  • Neoplasms
  • Pain
  • Pain Management
  • Pain Measurement
  • Palliative Care
  • Research Design

abstract

  • Improvement in cancer-related pain resulting from antitumor therapy is an important treatment benefit that can support drug approval and labeling claims when adequately measured if study results demonstrate statistically and clinically significant findings. Sponsors are encouraged to discuss pain palliation assessment methods with the FDA early in and throughout product development.

publication date

  • March 2014

Research

keywords

  • Academic Article

Identity

Language

  • eng

Digital Object Identifier (DOI)

  • 10.1002/cncr.28470

PubMed ID

  • 24375398

Additional Document Info

start page

  • 761

end page

  • 7

volume

  • 120

number

  • 5