FDA Provides Advice on How to Find What the Patients Want
[Thursday, October 10, 2019]

Over the last seven years, FDA has initiated numerous programs to increase patient perspective in the development of new drugs that they may need. Starting with the Patient-Focused Drug Development (PFDD) meetings that started in 2012, FDA has increased the weight of patient perspective in regulatory decisions. However, sponsors need instructions on how to interact with patients in a way that help the cause for their products. In the second guidance of the series of 4 planned guidance documents, FDA provided tips on what information to collect from patients to objectively measure what is important to the target patients for a given new drug. Sponsors should start with a combination of qualitative methods such as interviews and focus groups, and quantitative methods such as random surveys of patient populations to collect critical information about patient expectations. The guidance goes into great details of how to ask questions, what kind of questions to ask, the set-up for questions with patients, the various options for surveys, suggested ways to analyze data, and using the data to generate reports that could potentially be used to discuss with FDA and design studies. This is a must read guidance for not just sponsor looking to incorporate PFDD but any one looking to understand target population perspectives.