The Way Forward in Package Insert User Tests from a CRO’s Perspective



A significant increase in the amount of text in package inserts has been observed over the last years. This study investigated the consequences of this increase. Method: Five package inserts available on the German medicine market in 2002 and five developed model versions were investigated in a crossover procedure using the written readability test.


The more extensive the package inserts, the worse patients feel informed. Increasing the amount of text significantly decreases the ability to locate information, thus putting people off from reading the contents (P ≤ 0.021).


The results suggest that decreasing the amount of text is a key factor, whereby a maximum of 1,500 words per package insert should be the aim. Conclusion: The way forward in package insert user testing is to concentrate on patient requirements and package insert improvements. Appropriate solutions are required for the further development of guidelines, templates, and directives.

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Correspondence to Dr. Joerg Fuchs.

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Fuchs, J. The Way Forward in Package Insert User Tests from a CRO’s Perspective. Ther Innov Regul Sci 44, 119–129 (2010).

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Key Words

  • User test
  • Readability test
  • Package insert
  • Amount of text
  • Guidelines