Patient preferences can give us information that is critical for developing medical treatments. But they can also tell us how much risk patients think is acceptable for a given benefit. The methods to find out, or ‘elicit’ patients’ preferences are there, but decision makers are not sure how to assess and use them.
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.
Antonella Cardone Director
Cancer Patients Europe, Belgium
John F. P. Bridges, PhD Professor, Departments of Biomedical Informatics
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
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