PREFER | Patient Preferences in benefit risk assessments during the drug life cycle - Sofia ref.: 115966

Summary
The PREFER project will deliver an overview and evaluation of preference elicitation methods to be applied in the entire drug life cycle, i.e. in the early stages of identifying medical needs, in clinical testing, to guide decisions on reimbursement and to make decisions on withdrawal of drugs from the market. A broad array of (combinations of) patient preference methods will be tested prospectively in a large number of case studies. The availability of large patient cohorts will enable to test new methods or deviations from existing methods in a randomized manner, by comparing well-known methods with newer ones. The use of simulation studies will both contribute to smarter design of case studies and to exploring the sensitivity of outcomes of preference studies. Based on discussions with a broad representation of stakeholders e.g. patients, patient organisations, regulatory authorities, HTA bodies and reimbursement agencies, suitable methods will be tested and their contributions to improved decision making will be discussed in recommendations adapted to the needs of all relevant stakeholders. The recommendations from PREFER are expected to lead to changed practices, in that industry will routinely assess whether a preference study would add value at key decision points in the medicinal product life cycle and, if so, implement patient-preference elicitation studies according to the PREFER project recommendations. The PREFER consortium consist of 16 industry partners and 16 academic and SME members including representation from academia, patient organizations, HTA bodies, reimbursement agencies, and project management.
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More information & hyperlinks
Web resources: https://cordis.europa.eu/project/id/115966
Start date: 01-10-2016
End date: 31-05-2022
Total budget - Public funding: 12 015 547,00 Euro - 6 000 000,00 Euro
Cordis data

Original description

The PREFER project will deliver an overview and evaluation of preference elicitation methods to be applied in the entire drug life cycle, i.e. in the early stages of identifying medical needs, in clinical testing, to guide decisions on reimbursement and to make decisions on withdrawal of drugs from the market. A broad array of (combinations of) patient preference methods will be tested prospectively in a large number of case studies. The availability of large patient cohorts will enable to test new methods or deviations from existing methods in a randomized manner, by comparing well-known methods with newer ones. The use of simulation studies will both contribute to smarter design of case studies and to exploring the sensitivity of outcomes of preference studies. Based on discussions with a broad representation of stakeholders e.g. patients, patient organisations, regulatory authorities, HTA bodies and reimbursement agencies, suitable methods will be tested and their contributions to improved decision making will be discussed in recommendations adapted to the needs of all relevant stakeholders. The recommendations from PREFER are expected to lead to changed practices, in that industry will routinely assess whether a preference study would add value at key decision points in the medicinal product life cycle and, if so, implement patient-preference elicitation studies according to the PREFER project recommendations. The PREFER consortium consist of 16 industry partners and 16 academic and SME members including representation from academia, patient organizations, HTA bodies, reimbursement agencies, and project management.

Status

CLOSED

Call topic

IMI2-2015-05-01

Update Date

26-10-2022
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Horizon 2020
H2020-EU.3. SOCIETAL CHALLENGES
H2020-EU.3.1. SOCIETAL CHALLENGES - Health, demographic change and well-being
H2020-EU.3.1.7. Innovative Medicines Initiative 2 (IMI2)
H2020-EU.3.1.7.0. Cross-cutting call topics
H2020-JTI-IMI2-2015-05-two-stage
IMI2-2015-05-01 Patient perspective elicitation on benefits and risks of medicinal products, from development through the entire life cycle, to inform the decision-making process by regulators and Health Technology Assessment bodie