Europe – ICH reflection paper on proposed ICH guideline work to advance patient focused drug Development

Patients have direct experience in living with a disease. 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.

Growing patient advocacy and patient engagement, and continued advances in communication technologies, internet, social media, and a proliferation of information services and sources, have created a rich yet complex environment for eliciting and incorporating patient perspectives throughout the drug development process. In this environment it is increasingly critical to develop a harmonized approach to collecting and incorporating patient perspectives in drug development and decision making…