ICH E22 General considerations for patient preference studies - Scientific guideline
HumanScientific guidelines
Patient preference studies (PPS) aim to assess the relative desirability or acceptability of actual or potential health interventions, or their characteristics and outcomes. PPS can generate structured insights about the relative importance of characteristics, also referred to as attributes, that are considered by patients when making decisions about drugs. These attributes may include, for example, efficacy or safety outcomes or any other potentially relevant characteristics.
This harmonised guideline outlines general considerations about the use, design, conduct, analysis, and submission of PPS aimed at informing drug development, regulatory submission and evaluation, drug approvals and maintenance of such approvals.
This guideline addresses PPS and the value that patients place on characteristics of drugs. It does not focus on patient reported outcome measures.
Keywords: Patient Preference Studies (PPS), patient preference information, drug development, benefit-risk evaluation