Most patients have to accept treatments that come with both benefits and harms. The pharmaceutical industry, regulatory authorities, health technology assessment bodies, reimbursement agencies and patient organisations all agree that their perspective, or what is known as ‘patient preferences’, needs to be part of decision making on benefit and risk. But how? When? And what are the regulatory requirements for preference studies?

There are many methods to elicit patient preferences and large amounts of scientific literature. What is missing is a structured approach that takes all these perspectives into account. As so, PREFER, a public-private collaborative research project under the Innovative Medicines Initiative (IMI), will find out what the key stakeholders think is important in order to be able to establish recommendations to support the development of guidelines for industry, Regulatory Authorities and HTA bodies on how and when to include patient perspectives on benefits and risks of medicinal products.

In this Workshop, we will discuss and navigate through the value of Patient Preference studies, various frameworks and methods for conducting these studies, and the use of Patient Preferences in regulatory decision making.

• The value of Patient Preference studies
• Frameworks and Methods for Patient Preference studies
• The use of Patient Preferences in Regulatory Decision Making