Selecting participants when testing new drugs: the implications of age and gender discrimination

Med Leg J. 2002;70(Pt 3):130-4. doi: 10.1258/rsmmlj.70.3.130.

Abstract

Pharmaceutical products are rigorously tested for safety and efficacy prior to being licensed for use. During this testing process the archetypal research subject is a young male; women and older people are less frequently invited to participate. This is especially true at the early stages, but can also occur in the later phases of drug testing. This paper considers the reasons for the relative under-representation of these groups, and the legal implications of failing to include as research subjects the very types of people who will ultimately consume these drugs.

MeSH terms

  • Age Factors
  • Clinical Trials as Topic / ethics
  • Clinical Trials as Topic / methods*
  • Drugs, Investigational / adverse effects*
  • Drugs, Investigational / toxicity
  • Ethics, Research
  • Female
  • Human Experimentation / ethics
  • Human Experimentation / legislation & jurisprudence*
  • Humans
  • Male
  • Patient Rights / ethics
  • Research / legislation & jurisprudence*
  • Sex Factors

Substances

  • Drugs, Investigational