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Patients' voices are being taken

The voice of patients is on the move – and this time, the system is moving with it.

New international guidelines from the EMA and ICH mark an important shift in how patients’ experiences and preferences are understood and used in drug development and health decisions.

What was previously often seen as personal narratives is now beginning to gain status as structured knowledge with real influence.

 

What is particularly a step in the right direction is this:

 

    1. Patients’ experiences are recognised as data – not just stories
      With the ICH E22 guideline, Patient Preference Studies and Patient Experience Data become something that can be incorporated in a structured way into research, development and regulatory decisions. This means that what patients experience, feel and prioritise can be measured, documented and used systematically.

    2. Regulators are listening – and providing a clear framework When the EMA (and, in parallel, the FDA) publishes clear guidelines, it sends a strong signal to the industry: the patient perspective is not voluntary or ‘nice to have’ – it is something that is expected if done properly.

    3. Patient involvement moves from symbolism to influence
      Previously, patients were often consulted late in the process or in advisory forums without real decision-making power. Now, there is an opportunity for patient preferences to influence:
      • the choice of endpoints
      • the balance between efficacy and side effects
      • the design of studies and treatment courses

    4. Global direction – not isolated initiatives
      The fact that the EMA, FDA and international guidelines are moving in the same direction shows that this is not a buzzword, but a structural change in how we understand evidence and quality.

    5. The possibility of a real paradigm shift
      We are not there yet, but we have moved from ‘patients tell’ to ‘patients’ knowledge can influence decisions’. This is a crucial step, especially for people with chronic diseases, rare diseases and complex conditions.

That is why it is the right direction: Because patients are no longer just participants in the system – they are beginning to become co-creators of it.

 

The article can be downloaded here and read at your leisure as bedtime reading.

Patients’ voices are being taken seriously