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User Testing of Patient Leaflet

User Testing of Patient Leaflet

Cambridge Regulatory Services is a leading provider of readability testing in Europe.

CambReg was the first company to specialise in user testing services, before testing was mandatory. Operating leaflet testing services since 2004 makes CambReg unrivalled in terms of length and breadth of experience

What is User Testing (for medicinal products)? Directive 2001/83/EC (as amended by Directive 2004/27/EC) requires that consultation with target patient groups (‘user consultation’) be carried out to demonstrate the readability and usefulness of the package leaflet to patients.

Article 59(3): “The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use.” Readability Testing (or User Testing) of the leaflet is a commonly accepted way to satisfy these requirements

Is it mandatory?

User Testing of Patient Information Leaflets has been mandatory in the EU since 2005. Benefits of working with CambReg:

  • Fast turnaround
    Our average turnaround time for a standard PIL User Test is about 4 weeks. We can perform tests in less than 2 weeks if the conditions are right

  • A name well known and trusted by Health Authorities
    CambReg reports are routinely submitted to numerous EU Health Authorities; in the UK alone we are responsible for approximately 20% of all User Testing reports submitted to the MHRA.

    On many occasions the leaflets we have tested have featured as the MHRA's "PIL of the Month".

    MHRA inspectors were' satisfied' during an unannounced visit to review our processes

  • Competitive Pricing
    For loyal clients we offer multiple test discount packages. We offer both value for money and a high quality of service (a rare mix). CambReg has a large portfolio of satisfied clients who return for this service on egular basis .

CambReg’s Experience

Cambridge Regulatory Services has been providing the pharma industry with a superlative User Testing Service since 2004, leading the way, long before testing was mandatory. Now a highly successful core part of our business, CambReg’s experienced User Testing team has completed testing over 800 leaflets (307 full User Tests and over 500 bridging reports /focus tests), working across all sectors of the pharma industry including:

  • Novel preparations submitted via the Centralised Procedure
  • Generic products submitted via the Mutual Recognition and Decentralised Procedures
  • Herbal preparations
  • ‘Switch’ applications (legal status change)

Experience has shown that many companies do not capitalise on the option to bridge / focus test and often perform full testing unnecessarily. CambReg’s dynamic approach to bridging and focus strategies for whole product portfolios has proven to be highly successful and has significantly reduced the overall costs of this process for our clients.

Our approval rates are 100% - leaving aside projects where clients have ignored our initial advice regarding leaflet changes

What we offer

CambReg employs a User Testing method developed in Australia in the 1990s, which is outlined in the current EU and MHRA guidelines. . The process involves showing the leaflet to ‘the people who are likely to rely on the package leaflet' i.e. volunteers from the potential patient population who then identify the areas where improvements are necessary to ensure that the leaflet is legible, clear and easy to use.

The volunteers, selected from an extensive data base of thousands are invited in for testing no more frequently than 6 months. Our friendly team together with our dedicated User Testing suite provides them with an experience that they are happy to repeat.

Our ‘no frills’ Service – Ideal for clients with generic products, Includes:

  • Initial client consultation
  • Independent review of the leaflet
  • Minor rewrite of leaflet (up to 1 hour)
  • Preparation of protocol
  • Preparation of questionnaire
  • Pilot Test/Round 1/Round 2 Final Report

Our Platinum Service – Ideal for clients with novel products (new drug substance or new formulation) or other special requirements

CambReg understands that for clients with novel products a bespoke readability testing service is required. With our platinum service CambReg works hand in clove with the client’s project management team and draws on all acquired knowledge since 2004 to assist in creating a novel leaflet that will be fit for purpose and pass first time.

Platinum Service includes all of the above – plus:

  • Participation in client project meetings covering development of SPC & Leaflet
  • Participation in drafting the final wording of the PIL to optimise patient readability
  • Advice and guidance on testing and submission strategies
  • Liaison on questionnaire
  • Testing of multiple leaflets styles
  • Testing in multiple languages

Additional Services

Large portfolios of products Harmonisation before testing Leaflet Text Amendment
  • Strategic advice
  • Grouping/Justification for not testing
  • Focused testing
  • Across a product range
  • Across a set of countries
  • SPC/Leaflet comparison
  • Writing/rewriting of leaflet
  • Reformatting to Quality Review of Documents (QRD) template
Leaflet mock-up Design Recruitment of specialist panel Rapid Response to HA requests
  • Production
  • Amendment
  • Unusual/orphan diseases
  • Unusual patient populations
Audio recording of interviews

Does User Testing make any difference to the readability of leaflets?

Historically, many leaflets were in general poorly laid out and too lengthy due to the complexity of the Summary of Product Characteristics (SmPC) and / or information being given in scientific language in order to fulfil regulatory requirements.

Patients quickly lost interest in the document, failing to read or understand information crucial to the safe use of the medicine.

Our accumulated experience of writing and testing leaflets for different therapeutic areas has shown that at the end of the testing process every leaflet benefits from the process.

Patients benefit in real terms being able to more easily find and understand key information relevant to the safe and effective use of a product.

For more information or an estimate, contact us »

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