Disparate inclusion of older adults in clinical trials: priorities and opportunities for policy and practice change

Am J Public Health. 2010 Apr 1;100 Suppl 1(Suppl 1):S105-12. doi: 10.2105/AJPH.2009.162982. Epub 2010 Feb 10.

Abstract

Older adults are vastly underrepresented in clinical trials in spite of shouldering a disproportionate burden of disease and consumption of prescription drugs and therapies, restricting treatments' generalizability, efficacy, and safety. Eliminating Disparities in Clinical Trials, a national initiative comprising a stakeholder network of researchers, community advocates, policymakers, and federal representatives, undertook a critical analysis of older adults' structural barriers to clinical trial participation. We present practice and policy change recommendations emerging from this process and their rationale, which spanned multiple themes: (1) decision making with cognitively impaired patients; (2) pharmacokinetic differences and physiological age; (3) health literacy, communication, and aging; (4) geriatric training; (5) federal monitoring and accountability; (6) clinical trial costs; and (7) cumulative effects of aging and ethnicity.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Bias*
  • Clinical Protocols / standards
  • Clinical Trials as Topic*
  • Humans
  • Patient Selection*
  • Policy Making*
  • United States
  • United States Food and Drug Administration