Healthy volunteers

Healthy volunteers are individuals with no known significant health problems who volunteer to participate in clinical research.

What is the importance of healthy volunteers?
Healthy volunteers provide researchers with vital information during research by providing:

  • Normal reference ranges for the development of new diagnostic tests.
  • A control population to study the effects of a new intervention or to study the disease process.
  • Preliminary safety data in Phase I pharmacokinetic and pharmacodynamic trials.
  • Data to evaluate biosimilars versus anticancer biologic agents.

Informed consent must be obtained from healthy volunteers to ensure ethical and safe participation.

Source: Karakunnel, J. J., Bui, N., Palaniappan, L., Schmidt, K. T., Mahaffey, K. W., Morrison, B., Figg, W. D., & Kummar, S. (2018). Reviewing the role of healthy volunteer studies in drug development. Journal of Translational Medicine, 16(1).