Overview of comments received on 'ICH reflection paper on proposed ICH guideline work to advance patient focused drug development’

The key word here is “Perspective .” It is not essential to have “Lived experience” of a disease in order to have a patient perspective, although of course it certainly helps. But just as important is an ability to consider all of the implications of any given action, outcome measure or other objective in terms of its likely consequence for patient welfare and outcomes. The “Naive” patient will rarely have this kind of insight and is often far too easily influenced by others to express the viewpoint they are seeking, even if neither side recognises this is happening.

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Patients have direct experience in living with a disease, and their representatives have professional skills to use this experience for R&D and evaluation purposes . They have firsthand knowledge of the impact of the disease on their life and on how they feel and function. They bring a unique and valuable perspective to drug development, one that cannot be provided by the clinical, scientific, legal and other experts. It is important for health authorities and for drug developers to incorporate the patient’s perspective, beginning early in drug development. Patients have direct experience in living with a disease, and their representatives have professional skills to use this experience for R&D and evaluation purposes. They have firsthand knowledge of the impact of the disease on their life and on how they feel and function. They bring a unique and valuable perspective to drug development, one that cannot be provided by the clinical, scientific, legal and other experts. It is important for health authorities and for drug developers to incorporate the patient’s perspective, beginning early in drug development. It is important for health authorities and for drug developers to incorporate the patient’s

A missing key word is Commitment : Patients and their representatives tend to be fully committed to the search for safe and effective treatments, as they have “skin in the game”. Researchers are certainly conscientious in their approach to the task, it is however of a different order to that of someone who is committed.

‘It is important for health authorities and for drug developers to incorporate the patient’s perspective, beginning early in drug development’

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Overview of comments received on 'ICH reflection paper on proposed ICH guideline work to advance patient focused drug development’ (EMA/CHMP/ICH/415588/2020) EMA/194133/2021

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