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User Testing ... Time Is Running Out

Source: ICON

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Article: User Testing ... Time Is Running Out

Written and compiled by Dr. Tim Paget, Medical Director, ICON Development Solutions

22 Months And Counting ...
It is now over two years since Directive 2004/27/EC introduced a change in the order of presentation of information in patient information leaflets (PILs) and the requirement that PILs should reflect the results of consultations with target patient groups. We have until July 2008 to comply with Article 59(3) and to complete user tests for all existing, as well as new products. About 20,000 products will need to have undergone PIL testing by this time, with a minimum of 20 subjects identified and interviewed per protocol for each user test. There is currently a three-month lead time on user test delivery for most companies undertaking the work.

The principles of user testing are clear, and there are a number of providers for such work — some companies are setting up their own service. Even so, the challenge is the sheer volume of work needing to be undertaken and bringing this broad church of skills together in a streamlined way to ensure quality of work and a positive outcome, all within the regulatory timeframe.

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Article: User Testing ... Time Is Running Out