Food and Drug Administration (FDA) is developing four guidance documents to address, in a stepwise manner, how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making. The first document is dedicated to Patient-focused drug development and presents a general overview of methods and approaches for collecting patient experience data rather than focusing on methods for a specific, single purpose, e.g., to support collection of COA data or patient preference information. Although over the last years different initiatives have been carried out by the European Medicines Agency (EMA) to optimize the methodologies to collect high-quality data on medicines (Report – Patient Registries Workshop, 28 October 2016, see also ICH guideline E19 on optimisation of safety data collection) as well as to promote the actions for the public engagement highlights of EMA, a specific guide favouring the collection of patients experience and input in a functional and interactive mode is still missing.
The FDA guideline is available here and it is possible to provide comments and suggestions at this link.
