Kerrie-Anne is the Patient Preference Lead at UCB where she is responsible for providing strategic guidance and leading the implementation of health preference research to support the development of new drugs and treatments. Before joining UCB, she worked as a consultant implementing health preference studies for over four years across different indications and markets.
Patient experience data (PED) are intended to provide information about patients’ experiences with a disease or condition. There is growing interest from multiple stakeholders, including pharmaceutical companies to collect PED to inform the development and commercialisation of new drugs. Present efforts to generate PED ofen result in disjointed, overlapping, or duplicated efforts within and between pharmaceutical companies.
Regulatory authorities are encouraging the submission of patient experience data, including patient preference information (PPI). We provide an overview of PPI and the use of PPI in the regulatory setting. Many PP health studies recognise the usefulness of PPI, however, challenges remain in defining how and when to incorporate it in the regulatory process. While the use of PPI in regulatory decisions has been limited, regulatory agencies, sponsors, and researchers continue to work together to develop guidelines to integrate PPI into approval decisions.