Patient Preference Consultants and Experts list
MDIC PCBR Resources for Sponsors – Patient Preference Consultants and Experts list
Since the publication of the MDIC Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology in 2015 and the publication of CDRH’s Final Guidance on Patient Preference Information in 2016, MDIC has been encouraging its member companies to consider conducting their own patient preference studies as part of their regulatory submissions to the FDA.
One of the most frequent questions the MDIC staff are asked by sponsors and patient groups considering a patient preference study is “Where can I find a list of consultants and experts who might be able to help me conduct a patient preference study?” To help answer that question, MDIC solicited interested parties, including academics and scholars, with experience and interest in performing patient preference studies. The respondents who indicated to MDIC that they are capable of providing support to a regulatory patient preference study are listed below.
Please note that inclusion on this list is not an endorsement by MDIC or FDA. Those listed were asked to provide basic information about their capabilities for inclusion on this list, but neither MDIC nor the FDA has validated this information, checked references, or otherwise validated those capabilities. Sponsors looking to find a consultant to conduct a patient preference study should conduct their own assessment of their capabilities prior to hire.
If you have experience performing regulatory patient preference studies and would like to be included on this list, please contact Stephanie Christopher (SChristopher@MDIC.org).
Consultants and Experts
Kathy Beusterien, Outcomes Research Strategies in Health
Contact information
1.202.362.8606
kathy.beusterien@orshealth.com
www.orshealth.com
Experience conducting studies
Medical Device Companies
Pharmaceutical Companies
Academic publication
Methods
Time tradeoff
Standard gamble
Direct-assessment questions
Conjoint analysis and discrete-choice experiments
Best-worse scaling exercises
Direct questions in clinical trials
Contingent valuation
Qualitative methods
Jade Cusick, Kantar Health
Contact information
+1.917.815.4412
jade.cusick@kantarhealth.com
www.kantarhealth.com
Experience conducting studies
Medical Device Companies
Pharmaceutical Companies
Academic Publication
Methods
Simple direct weighting
Ranking exercises
Swing weighting
Point allocation
Analytic hierarchy process
Outranking methods
Time tradeoff
Standard gamble
Direct-assessment questions
Threshold technique
Conjoint analysis and discrete-choice experiments
Best-worse scaling exercises
Contingent valuation
Qualitative methods
Multi-criteria decision analysis (MCDA)
James Dolan, MD, University of Rochester
Contact information
585-276-5161
james_dolan@urmc.rochester.edu
www.mcdm-med.com
Experience conducting studies
Pharmaceutical companies
Academic publication
Methods
Ranking exercises
Analytic hierarchy process
Multi-criteria decision analysis (MCDA)
Simon Fifer, CaPPRe
Contact information
+61 (0)403 862 091
simon.fifer@cappre.com.au
www.cappre.com.au
Experience conducting studies
Medical Device Companies
Pharmaceutical Companies
Patient advocacy groups
Academic publication
Methods
Simple direct weighting
Ranking exercises
Point allocation
Direct-assessment questions
Conjoint analysis and discrete-choice experiments
Best-worse scaling
Patient-preference trials
Contingent valuation
Qualitative methods
Adam Gater, Adelphi Values
Contact information
+44 (0)1625 577485
adam.gater@adelphivalues.com
www.adelphivalues.com/
Experience conducting studies
CDER
CBER
Other regulatory agencies
Pharmaceutical companies
Patient advocacy groups
Academic publication
Methods
Ranking exercises
Point allocation
Time tradeoff
Direct-assessment questions
Threshold technique
Conjoint analysis and discrete-choice experiments
Best-worse scaling exercises
Patient-preference trials
Direct questions in clinical trials
Qualitative methods
Brett Hauber, RTI Health Solutions
Contact information
919-597-5149
abhauber@rti.org
www.rtihs.org
Experience conducting studies
CDRH
CDER
Other Regulatory Agencies
Medical Device Companies
Pharmaceutical Companies
Patient Advocacy Groups
Academic Publication
Methods
Point allocation
Time tradeoff
Standard gamble
Direct-assessment questions
Threshold technique
Conjoint analysis and discrete-choice experiments
Best-worst scaling exercises
Contingent valuation
F. Reed Johnson, Duke Clinical Research Institute
Contact information
919-668-1975
reed.johnson@duke.edu
www.dcri.org/our-work/health-services-research/prefer/
Experience conducting studies
CDRH
CDER
Other Regulatory Agencies
Medical Device Companies
Pharmaceutical Companies
Patient Advocacy Groups
Academic Publication
Methods
Simple direct weighting
Ranking exercises
Swing weighing
Point allocation
Time tradeoff
Standard gamble
Direct-assessment questions
Threshold technique
Conjoint analysis and discrete-choice experiments
Best-worst scaling exercises
Patient-preference trials
Direct questions in clinical trials
Contingent valuation
Qualitative methods
Multi-criteria decision analysis (MDCA)
Carrie Kuehn, Evergreen Strategic Consulting
Contact information
425-241-6510
carrie.kuehn@esc-strategic.com
www.esc-strategic.com
Experience conducting studies
CDRH
Medical Device Companies
Academic publications
Methods
Ranking exercises
Point allocation
Direct-assessment questions
Threshold technique
Conjoint analysis and discrete-choice experiments
Best-worst scaling exercises
Direct questions in clinical trials
Qualitative methods
Kevin Marsh, Evidera
Contact information
+44 (0)208 576 5025
kevin.marsh@evidera.com
www.evidera.com/services-products/patient-preferences/
Experience conducting studies
CDRH
CDER
Other regulatory agencies
Medical Device Companies
Pharmaceutical Companies
Patient advocacy groups
Academic publications
Methods
Simple direct weighting
Ranking exercises
Swing weighting
Point allocation
Time tradeoff
Standard gamble
Direct-assessment questions
Threshold technique
Conjoint analysis and discrete-choice experiments
Best-worse scaling exercises
Contingent valuation
Qualitative methods
Multi-criteria decision analysis (MCDA)
Axel Muhlbacher, Gesellschaft empirische Beratung GMBH, Hochschule Neubrandenburg
Contact information
0049 (0) 395 – 5693 3301
0049 (0) 395 – 5693 3304
muehlbacher@empirischeberatung.de
muehlbacher@hs-nb.de
muehlbacher@me.com
www.hs-nb.de/fachbereich-gesundheit-pflege-management/forschung-und-projekte/institute/igm-gesundheitsoekonomie-und-medizinmanagement/
Experience conducting studies
Other regulatory agencies
Medical Device Companies
Pharmaceutical Companies
Patient advocacy groups
Academic publication
Methods
Simple direct weighting
Ranking exercises
Point allocation
Analytic hierarchy process
Direct-assessment questions
Conjoint analysis and discrete-choice experiments
Best-worse scaling exercises
Contingent valuation
Multi-criteria decision analysis (MCDA)