The University of North Carolina at Chapel Hill
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U.K. Clinical Trial Application → Types of Trials

The category depends on the potential human risk of the investigational medicinal product

  • No higher than the risk of standard medical care
    • Example:
      • Trials involving medicinal products licensed in any EU Member State if they relate to the already licensed indications, dosage and form.
      • Trials involve off-label use if this off-label use is an established practice and supported by sufficient published evidence and/or guidelines.
  • Somewhat higher than the risk of standard medical care
    • Example:
      • Trials involving medicinal products licensed in any EU Member State if they are used for a new indication (different patient population/disease group) or substantial dosage modifications are made, or if they are used in combinations for which interactions are suspected.
      • Trials involving medicinal products not licensed in any EU Member State if the active substance is part of a medicinal product licensed in the EU.
  • Markedly higher than the risk of standard medical care
    • Example:
      • Trials involving a medicinal product not licensed in any EU Member State.