Patient preferences: rheumatoid arthritis drug development
The primary reason of all drugs is to benefit the patients. To get licensed, benefits must be shown to be greater than the risks. The evaluation of this balance relies on regulatory process.
Aim
This PhD project will look at how rheumatoid arthritis patient preferences can provide added value in regulatory decision making in the drug development process.
The project is entitled "The value of patient preferences in drug development for rheumatoid arthritis". It is part of PREFER, a public-private partnership funded by the Innovative Medicines Initiative.
Background
Drugs are designed to benefit patients. To get a drug approved, regulators assess the drug with regard to effectiveness, quality and safety. There is an increasing demand to in include patient’s preferences in this regulatory process.However, there is still a need for knowledge on how and to what extent patient preferences can be used and add value to the regulatory process.
The project focus on patients with Rheumatoid Arthritis (RA). These patients suffer from a chronic inflammatory disease characterized by tenderness, swelling and joint damage. This can led to disability and premature death. There are different treatment options with different risks and benefits. Which is one of the reasons RA patients make an interesting case for preference studies. If patients received treatment in line with their preferences, they will most likely be more satisfied and compliant in taking their medication.
About the PREFER project
PREFER looks at how and when it is best to perform and include patient-preference in decision making during the drug life cycle. We include patient stakeholders at every level of the project. The end result will be recommendations to support development of guidelines for industry, Regulatory Authorities and HTA bodies.
The Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER) project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115966. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA.
Time table
2017-2021
Contact
Karin Schölin Bywall, MA, PhD student
Supervisors
- Ulrik Kihlbom, Associate Professor of Medical Ethics, Senior Lecturer
- Jorien Veldwijk, PhD Risk Economics
- Mats G Hansson, Professor of Biomedical Ethics