Mt-Isa S, Costa M, Boeri M, Colopy M, Garczarek U, Schacht A, Saint-Hillary G. Stated preference methods: eliciting patient preferences in the age of personalized medicine. Presented at the 2019 PSI Conference; June 2, 2019. London, United Kingdom.

Many crucial questions need to be answered throughout drug development: “which efficacy measures best represent clinically meaningful outcomes?”, “which adverse events should be monitored closely?”, “what drives the decision: maximizing efficacy or reducing the risk of adverse events?”

The answers to these questions reflect an element of judgment by the clinical team. To enhance transparency and increase robustness of the decision-making process additional viewpoints can be included. With this in mind, pharmaceutical companies can conduct preference elicitation studies as part of clinical development programs to assess how the benefit-risk trade-off of a new drug will impact various stakeholders. Typically, these studies focus on patient preferences, in an effort to bring the patients’ view into the drug development process, but other stakeholders, such as physicians, can also be included in the assessment.

Although regulatory agencies have started discussing how to use preference elicitation to support decision-making, and new draft guidelines are now open for public consultation, statisticians have not yet been engaged on this topic. Preference data present new challenges for many statisticians. If you have limited experience yourself on this topic, then you are not alone. At the end of this course you should be able to understand the advantages and challenges characterizing preference elicitation, how it relates to benefit-risk assessment, and how to apply it to your own project.

There is no pre-requisite for the course, but attendees are assumed to be familiar with statistical methods in the drug development lifecycle.

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