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
Who should attend?
European Cancer Patient Coalition (ECPC), Belgium
John F. P. Bridges, PhD•Professor, Departments of Biomedical Informatics and Surgery
Ohio State University College of Medicine, United States
Jürgen Kübler, PhD•Owner
Quantitative Scientific Consulting, Germany
Laura Lee Johnson, PhD•Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER
FDA, United States
Mireille Muller, DrSc, PhD, MSc•Regulatory Policy & Intelligence Director
Novartis Pharma AG, Switzerland
Sara Torgal, MPharm•Senior Manager, Scientific Programs