The European Medicines Agency (EMA) published the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) reflection paper on Proposed ICH Guideline Work to Advance Patient Focused Drug Development. This document is open for public consultation until 7 March 2021.
The reflection paper is based on the principle that health authorities and medicine developers must incorporate the patient's perspective from the beginning of the medicine development process. It discusses how to incorporate patient experience to better inform about medicine development and regulatory decision-making, as well as proposed topics for future ICH guideline development supporting patient-focused drug development. The document also explores the potential to develop new ICH guidelines on clinical outcome measures, clinical outcome assessments, clinical endpoints, or clinically meaningful change.
Through this paper, the ICH and the EMA take the stance that it is important to develop a globally harmonised approach on how to include the patient's perspective. The paper states that patients have direct experience in living with a disease, and its impact on their life and themselves. As such, they bring a "unique and valuable" perspective to medicine development that cannot be replicated clinically, scientifically, or legally by any other experts.
The full document can be found here
