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

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

Objective

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.

Coordinator

UPPSALA UNIVERSITET

Address

Von Kraemers Alle 4
751 05 Uppsala

Sweden

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 1 566 849

Participants (32)

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UNIVERSITAIR MEDISCH CENTRUM UTRECHT

Netherlands

EU Contribution

€ 618 672

ERASMUS UNIVERSITEIT ROTTERDAM

Netherlands

EU Contribution

€ 551 125

KATHOLIEKE UNIVERSITEIT LEUVEN

Belgium

EU Contribution

€ 683 750

THE UNIVERSITY OF BIRMINGHAM

United Kingdom

EU Contribution

€ 238 750

UNIVERSITATSKLINIKUM ERLANGEN

Germany

EU Contribution

€ 233 722

ISTITUTO EUROPEO DI ONCOLOGIA SRL

Italy

EU Contribution

€ 335 000

MINDBYTES

Belgium

EU Contribution

€ 259 937

"INSTITUTO TUMORI ""GIOVANNI PAOLO II"""

Italy

EU Contribution

€ 233 275

EUROPEAN CANCER PATIENT COALITION

Belgium

EU Contribution

€ 223 250

STEINBEISSER PROJECT MANAGEMENT UG (HAFTUNGSBESCHRANKT)

Germany

EU Contribution

€ 262 500

UNIVERSITY OF NEWCASTLE UPON TYNE

United Kingdom

EU Contribution

€ 264 922

FEDERAAL KENNISCENTRUM VOOR DE GEZONDHEIDSZORG

Belgium

EU Contribution

€ 252 500

MUSCULAR DYSTROPHY GROUP OF GREAT BRITAIN AND NORTHERN IRELAND

United Kingdom

EU Contribution

€ 80 000

NOVARTIS PHARMA AG

Switzerland

AMGEN LIMITED

United Kingdom

ASTELLAS PHARMA EUROPE BV

Netherlands

Bayer Pharma AG

Germany

Eli Lilly and Company Limited

United Kingdom

JANSSEN PHARMACEUTICA NV

Belgium

SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT

France

ACTELION PHARMACEUTICALS LTD

Switzerland

PFIZER LIMITED

United Kingdom

MERCK SHARP & DOHME CORP

United States

ASTRAZENECA AB

Sweden

CSL BEHRING GMBH

Germany

MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN

Germany

F. HOFFMANN-LA ROCHE AG

Switzerland

AbbVie Ltd

United Kingdom

TAKEDA DEVELOPMENT CENTRE EUROPE LTD.

United Kingdom

FORUM EUROPEEN DES PATIENTS (FPE)

Luxembourg

EU Contribution

€ 65 000

INTERNATIONAL ALLIANCE OF PATIENT'ORGANIZATIONS

United Kingdom

EU Contribution

€ 63 173

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

Netherlands

EU Contribution

€ 67 575

Project information

Grant agreement ID: 115966

Status

Ongoing project

  • Start date

    1 October 2016

  • End date

    30 September 2021

Funded under:

H2020-EU.3.1.7.

  • Overall budget:

    € 12 000 001

  • EU contribution

    € 6 000 000

Coordinated by:

UPPSALA UNIVERSITET

Sweden