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PREFER SIGNED

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

Total Cost €

0

EC-Contrib. €

0

Partnership

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Project "PREFER" data sheet

The following table provides information about the project.

Coordinator
UPPSALA UNIVERSITET 

Organization address
address: VON KRAEMERS ALLE 4
city: UPPSALA
postcode: 751 05
website: www.uu.se

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Sweden [SE]
 Project website http://www.imi-prefer.eu
 Total cost 12˙000˙001 €
 EC max contribution 6˙000˙000 € (50%)
 Programme 1. H2020-EU.3.1.7. (Innovative Medicines Initiative 2 (IMI2))
 Code Call H2020-JTI-IMI2-2015-05-two-stage
 Funding Scheme IMI2-RIA
 Starting year 2016
 Duration (year-month-day) from 2016-10-01   to  2021-09-30

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    UPPSALA UNIVERSITET SE (UPPSALA) coordinator 1˙566˙849.00
2    KATHOLIEKE UNIVERSITEIT LEUVEN BE (LEUVEN) participant 683˙750.00
3    UNIVERSITAIR MEDISCH CENTRUM UTRECHT NL (UTRECHT) participant 618˙672.00
4    ERASMUS UNIVERSITEIT ROTTERDAM NL (ROTTERDAM) participant 551˙125.00
5    ISTITUTO EUROPEO DI ONCOLOGIA SRL IT (MILANO) participant 335˙000.00
6    UNIVERSITY OF NEWCASTLE UPON TYNE UK (NEWCASTLE UPON TYNE) participant 264˙922.00
7    STEINBEISSER PROJECT MANAGEMENT UG (HAFTUNGSBESCHRANKT) DE (MUNCHEN) participant 262˙500.00
8    MINDBYTES BE (MERKSPLAS) participant 259˙937.00
9    FEDERAAL KENNISCENTRUM VOOR DE GEZONDHEIDSZORG BE (BRUXELLES) participant 252˙500.00
10    THE UNIVERSITY OF BIRMINGHAM UK (BIRMINGHAM) participant 238˙750.00
11    UNIVERSITATSKLINIKUM ERLANGEN DE (ERLANGEN) participant 233˙722.00
12    "INSTITUTO TUMORI ""GIOVANNI PAOLO II""" IT (BARI) participant 233˙275.00
13    EUROPEAN CANCER PATIENT COALITION BE (BRUXELLES) participant 223˙250.00
14    MUSCULAR DYSTROPHY GROUP OF GREAT BRITAIN AND NORTHERN IRELAND UK (LONDON) participant 80˙000.00
15    ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM NL (ROTTERDAM) participant 67˙575.00
16    FORUM EUROPEEN DES PATIENTS (FPE) LU (LUXEMBOURG) participant 65˙000.00
17    INTERNATIONAL ALLIANCE OF PATIENT'ORGANIZATIONS UK (LONDON) participant 63˙173.00
18    AbbVie Ltd UK (Maidenhead) participant 0.00
19    ACTELION PHARMACEUTICALS LTD CH (ALLSCHWIL) participant 0.00
20    AMGEN LIMITED UK (CAMBRIDGE) participant 0.00
21    ASTELLAS PHARMA EUROPE BV NL (LEIDEN) participant 0.00
22    ASTRAZENECA AB SE (SODERTAELJE) participant 0.00
23    Bayer Pharma AG DE (Berlin) participant 0.00
24    CSL BEHRING GMBH DE (MARBURG) participant 0.00
25    Eli Lilly and Company Limited UK (Basingstoke) participant 0.00
26    F. HOFFMANN-LA ROCHE AG CH (BASEL) participant 0.00
27    JANSSEN PHARMACEUTICA NV BE (BEERSE) participant 0.00
28    MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN DE (DARMSTADT) participant 0.00
29    MERCK SHARP & DOHME CORP US (WHITEHOUSE STATION NJ) participant 0.00
30    NOVARTIS PHARMA AG CH (BASEL) participant 0.00
31    PFIZER LIMITED UK (SANDWICH) participant 0.00
32    SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT FR (Chilly Mazarin) participant 0.00
33    TAKEDA DEVELOPMENT CENTRE EUROPE LTD UK (LONDON) participant 0.00

Map

 Project 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.

 Deliverables

List of deliverables.
Report characterising the types and possible role of psychological instruments and educational tools in measuring patient preferences Documents, reports 2020-04-08 21:05:17
Report characterising the criteria to be used to assess the performance of patient-preference methods, the performance of the methods on these criteria, and a gap analysis Documents, reports 2020-04-08 21:05:17
Final scope document for recommendations Documents, reports 2020-04-08 21:05:18
Dissemination and communication plan Documents, reports 2020-04-08 21:05:18
Report describing the candidate methodologies and assessment criteria to go forward for testing in empirical case studies and simulation studies Documents, reports 2020-04-08 21:05:18
Initial data management plan Documents, reports 2020-04-08 21:05:18
Report characterising the desires, expectations concerns, and requirements of stakeholders about methodologies for patient-preference elicitation Documents, reports 2020-04-08 21:05:17
Open workshop on preference elicitation Websites, patent fillings, videos etc. 2020-04-08 21:05:18
Report describing existing processes, conditions, and contextual factors that influence the utility and role of patientpreference studies and the rationale behind such influence Documents, reports 2020-04-08 21:05:17
Report characterising the decision points throughout the medicinal product life cycle, the activities that are carried out in each step, and the types of assessments made at these points, as well as the assessment criteria used by different stakeholders Documents, reports 2020-04-08 21:05:17
Website launch Websites, patent fillings, videos etc. 2020-04-08 21:05:18
Report describing existing qualitative and quantitative methods for measuring patient benefit-risk preferences in medical treatment Documents, reports 2020-04-08 21:05:17
Report describing the requirements for patient-preference elicitation case studies to inform benefit-risk decision making for industry, Regulatory Authorities, HTA bodies, and reimbursement agencies at different decision points Documents, reports 2020-04-08 21:05:18
Defining Key Performance Indicators (KPIs) Documents, reports 2020-04-08 21:05:18
Final report on operational requirements for the conduct of case studies Documents, reports 2020-02-17 17:32:43

Take a look to the deliverables list in detail:  detailed list of PREFER deliverables.

 Publications

year authors and title journal last update
List of publications.
2019 Rosanne Janssens, Selena Russo, Eline van Overbeeke, Chiara Whichello, Sarah Harding, Jürgen Kübler, Juhaeri Juhaeri, Karin Schölin Bywall, Alina Comanescu, Axel Hueber, Matthias Englbrecht, Nikoletta Nikolenko, Gabriella Pravettoni, Steven Simoens, Hilde Stevens, Richard Hermann, Bennett Levitan, Irina Cleemput, Esther de Bekker-Grob, Jorien Veldwijk, Isabelle Huys
Patient Preferences in the Medical Product Life Cycle: What do Stakeholders Think? Semi-Structured Qualitative Interviews in Europe and the USA
published pages: 513-526, ISSN: 1178-1653, DOI: 10.1007/s40271-019-00367-w
The Patient - Patient-Centered Outcomes Research 12/5 2020-04-08
2019 Vikas Soekhai, Chiara Whichello, Bennett Levitan, Jorien Veldwijk, Cathy Anne Pinto, Bas Donkers, Isabelle Huys, Eline van Overbeeke, Juhaeri Juhaeri, Esther W. de Bekker-Grob
Methods for exploring and eliciting patient preferences in the medical product lifecycle: a literature review
published pages: 1324-1331, ISSN: 1359-6446, DOI: 10.1016/j.drudis.2019.05.001
Drug Discovery Today 24/7 2020-04-08
2019 Rosanne Janssens, Isabelle Huys, Eline van Overbeeke, Chiara Whichello, Sarah Harding, Jürgen Kübler, Juhaeri Juhaeri, Antonio Ciaglia, Steven Simoens, Hilde Stevens, Meredith Smith, Bennett Levitan, Irina Cleemput, Esther de Bekker-Grob, Jorien Veldwijk
Opportunities and challenges for the inclusion of patient preferences in the medical product life cycle: a systematic review
published pages: , ISSN: 1472-6947, DOI: 10.1186/s12911-019-0875-z
BMC Medical Informatics and Decision Making 19/1 2020-04-08
2019 Selena Russo, Chiara Jongerius, Flavia Faccio, Silvia F.M. Pizzoli, Cathy Anne Pinto, Jorien Veldwijk, Rosanne Janssens, Gwenda Simons, Marie Falahee, Esther de Bekker-Grob, Isabelle Huys, Douwe Postmus, Ulrik Kihlbom, Gabriella Pravettoni
Understanding Patients\' Preferences: A Systematic Review of Psychological Instruments Used in Patients\' Preference and Decision Studies
published pages: 491-501, ISSN: 1098-3015, DOI: 10.1016/j.jval.2018.12.007
Value in Health 22/4 2020-04-08
2019 Chiara Whichello, Eline van Overbeeke, Rosanne Janssens, Karin Schölin Bywall, Selena Russo, Jorien Veldwijk, Irina Cleemput, Juhaeri Juhaeri, Bennett Levitan, Jürgen Kübler, Meredith Smith, Richard Hermann, Matthias Englbrecht, Axel J. Hueber, Alina Comanescu, Sarah Harding, Steven Simoens, Isabelle Huys, Esther W. de Bekker-Grob
Factors and Situations Affecting the Value of Patient Preference Studies: Semi-Structured Interviews in Europe and the US
published pages: , ISSN: 1663-9812, DOI: 10.3389/fphar.2019.01009
Frontiers in Pharmacology 10 2020-04-08
2017 Esther W. de Bekker-Grob, Conny Berlin, Bennett Levitan, Karim Raza, Kalliopi Christoforidi, Irina Cleemput, Jana Pelouchova, Harald Enzmann, Nigel Cook, Mats G. Hansson
Giving Patients’ Preferences a Voice in Medical Treatment Life Cycle: The PREFER Public–Private Project
published pages: 263-266, ISSN: 1178-1653, DOI: 10.1007/s40271-017-0222-3
The Patient - Patient-Centered Outcomes Research 10/3 2020-04-08
2018 Eline van Overbeeke, Chiara Whichello, Rosanne Janssens, Jorien Veldwijk, Irina Cleemput, Steven Simoens, Juhaeri Juhaeri, Bennett Levitan, Jürgen Kübler, Esther de Bekker-Grob, Isabelle Huys
Factors and situations influencing the value of patient preference studies along the medical product lifecycle: a literature review
published pages: , ISSN: 1359-6446, DOI: 10.1016/j.drudis.2018.09.015
Drug Discovery Today 2020-04-08
2018 de Bekker-Grob, Esther W.; Juhaeri, Juhaeri; Kihlbom, Ulrik; Levitan, Bennett et al.
Giving patients\' preferences a voice in the medical product lifecycle: w018y, when and how?: The public-private PREFER project: Work package 2
published pages: p. 19-21, ISSN: 2375-866X, DOI:
ISPOR Value & Outcomes Spotlight Vol. 4, no 3 2020-04-08

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