Drug Evaluation Committee Introduction to Patient Preference Studies
In recent years, patient preference data has come to be regarded as critical information that influences the assessment of a drug’s value from the patient’s perspective. Regarding patient preference studies—which are conducted to obtain such data for use in drug development and regulatory submissions—the ICH E22 “General Guidelines on Patient Preference Studies” is scheduled to reach Step 4 by the end of 2026.However, when considering the actual implementation of patient preference studies, there were virtually no published books or reports on the subject in Japan.
Therefore, we have prepared this report with the aim of enabling the conduct of patient preference studies intended to be used as evidence in pharmaceutical development—drawing on real-world examples as necessary—and, in particular, to ensure that those in charge can carry out these studies from planning through reporting, including from a data science perspective.We hope this report will be of assistance to companies as they conduct patient preference studies.