Patient Information Leaflet (PIL) User Testing

The EU Guideline on the Readability of the Label and Package Leaflet of Medicinal Products for Human Use, issued in 1999, made detailed recommendations for the diagnostic user testing of Patient Information Leaflets (PILs). In June 2005, the MHRA issued its own Guidance on the User Testing of PILs.

Since 1 July 2005, legal provisions have existed in the United Kingdom to ensure that the information provided in PILs is clear and easy to use. PILs must now reflect the results of consultations with target patient groups and the results of these consultations must be provided to regulatory authorities.

The MHRA Guidance requires more than leaflet ‘readability’ to be tested. User testing requires a comprehensive assessment of how easily patients can find information in a PIL, how well they understand the information and whether they would be able to act on the information.

Sequani Clinical has designed a protocol specifically for the user testing of PILs in accordance with the MHRA’s Guidance.

The Sequani Clinical database of local volunteers means that we have ready access to the general population allowing us to select a panel of subjects for a PIL user test according to the demographic profile that best matches the target users of your products.

Many of our staff also have direct relevant experience working in the pharmaceutical industry for many years; including writing and advising on SmPCs, PILs and expert reports. They are well placed to oversee subject interviews in PIL user tests.