The human dimension in the assessment of medicines: Perception, preferences, and decision making in the European regulatory environment

Andrea Rose-Marie Beyer

The human dimension in the assessment of medicines: Perception, preferences, and decision making in the European regulatory environment

Andrea Rose-Marie Beyer

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Er is duidelijk bewijs dat mensen risicovolle situaties op verschillende manieren benaderen en er zijn enkele trends waarneembaar met betrekking tot het zien of het nemen van risico's. De invloed van sociale/culturele factoren op onze interactie met technologische vooruitgang, in dit geval medische vooruitgang, wordt al tientallen jaren openlijk erkend door onderzoekers gespecialiseerd in risico's. Dit geldt echter alleen voor leken. Experts konden aan een soortgelijke kritiek ontsnappen met betrekking tot de factoren die invloed hebben op hun visies op potentiële risico's. Van hen wordt aangenomen dat ze zich alleen richten op de waarschijnlijkheid en omvang van het risico. Hierdoor zouden ze in de praktijk de deur sluiten richting een daadwerkelijk dialoog met patiënten en andere niet-experts. De eerste drie hoofdstukken van deze scriptie presenteren de resultaten van veldonderzoek gericht op het evalueren van het psychometrische paradigma onder een groep experts die zich bezighouden met risico-evaluatie binnen de omgeving van farmaceutische regulatie. Het vierde hoofdstuk biedt de resultaten van een multi-criteria tool voor hulp bij besluitvorming die binnen de omgeving van farmaceutische regulatie wordt geëvalueerd en laat zien dat het haalbaar is om dergelijke methodes te integreren binnen het bestaande evaluatieproces voor voordelen vs. risico. De twee laatste hoofdstukken gaan verder op het eerdere hoofdstuk, door gebruik te maken van een multi-criteria benadering om voorkeuren voor behandelresultaten onder patiënten en onder experts (medische beoordelaars) vast te leggen voor 'echte' behandelbeslissingen. Vanaf hier kunnen we beginnen met het kwantificeren waar de waarden met betrekking tot acceptabele voordelen en risico's van expert en de niet-expert verschillen en waar ze samenkomen. Nieuwe paden voor communicatie tussen alle belanghebbenden op het gebied van medisch onderzoek kunnen gevormd worden en de concepten van dialoog en gedeelde besluitvorming kunnen worden gerealiseerd binnen het veld van farmaceutische regulatie.

Originele taal-2	English
Kwalificatie	Doctor of Philosophy
Toekennende instantie	Rijksuniversiteit Groningen
Begeleider(s)/adviseur	Hillege, Hans, Supervisor de Graeff, Pieter, Supervisor Fasolo, Barbara, Co-supervisor, Externe Persoon
Datum van toekenning	28-okt.-2015
Plaats van publicatie	[Groningen]
Uitgever	University of Groningen
Gedrukte ISBN's	978-94-6182-614-5
Status	Published - 2015

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Title and contents Final publisher's version, 505 KB
Chapter 1 Final publisher's version, 300 KB
Chapter 2.1 Final publisher's version, 1,18 MB
Chapter 2.2 Final publisher's version, 1,26 MB
Chapter 2.3 Final publisher's version, 63,5 KB
Chapter 3 Final publisher's version, 6,55 MB
Chapter 4 Final publisher's version, 7 MB
Chapter 5 Final publisher's version, 1,03 MB
Summary and samenvatting Final publisher's version, 1,26 MB
Addendum Final publisher's version, 1,27 MB
Complete thesisFinal publisher's version, 6,98 MB
PropositionsFinal publisher's version, 23 KB

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title = "The human dimension in the assessment of medicines: Perception, preferences, and decision making in the European regulatory environment",

abstract = "There is clear evidence that individuals approach risky situations differently, and there are some discernible trends with regards to perceiving or taking risks. The influence of social/cultural factors on our interaction with technological advances, in this case medical advances, has been openly acknowledged by risk researchers for decades, but only for laypeople. Experts have escaped similar scrutiny into the factors that influence their views on potential risks, and have been assumed to focus only of the probability and the magnitude of the risk, effectively closing the door to real dialogue with patients and other non-experts. The first three chapters of this thesis present the results of field studies aimed at evaluating the psychometric paradigm among a group of experts who conduct risk evaluation within the pharmaceutical regulatory environment. The fourth chapter, provides results of a multi-criteria decision support tool evaluated within the pharmaceutical regulatory environment and shows that it is feasible to integrate such methods within the existing benefit-risk evaluation process. The two final chapters present an advance on the previous chapter by using a multi-criteria approach to capture preferences for treatment outcomes among patients and among experts (medical assessors) for {\textquoteleft}real{\textquoteright} treatment decisions. From this we can begin to quantify where the expert and the non-expert values on acceptable benefits and risks differ and where they converge. New paths for communication between all stakeholders in the field of medical research can be forged and the concepts of dialogue and shared decision-making realised within the field of pharmaceutical regulation.",

author = "Beyer, {Andrea Rose-Marie}",

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T1 - The human dimension in the assessment of medicines

T2 - Perception, preferences, and decision making in the European regulatory environment

AU - Beyer, Andrea Rose-Marie

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N2 - There is clear evidence that individuals approach risky situations differently, and there are some discernible trends with regards to perceiving or taking risks. The influence of social/cultural factors on our interaction with technological advances, in this case medical advances, has been openly acknowledged by risk researchers for decades, but only for laypeople. Experts have escaped similar scrutiny into the factors that influence their views on potential risks, and have been assumed to focus only of the probability and the magnitude of the risk, effectively closing the door to real dialogue with patients and other non-experts. The first three chapters of this thesis present the results of field studies aimed at evaluating the psychometric paradigm among a group of experts who conduct risk evaluation within the pharmaceutical regulatory environment. The fourth chapter, provides results of a multi-criteria decision support tool evaluated within the pharmaceutical regulatory environment and shows that it is feasible to integrate such methods within the existing benefit-risk evaluation process. The two final chapters present an advance on the previous chapter by using a multi-criteria approach to capture preferences for treatment outcomes among patients and among experts (medical assessors) for ‘real’ treatment decisions. From this we can begin to quantify where the expert and the non-expert values on acceptable benefits and risks differ and where they converge. New paths for communication between all stakeholders in the field of medical research can be forged and the concepts of dialogue and shared decision-making realised within the field of pharmaceutical regulation.

AB - There is clear evidence that individuals approach risky situations differently, and there are some discernible trends with regards to perceiving or taking risks. The influence of social/cultural factors on our interaction with technological advances, in this case medical advances, has been openly acknowledged by risk researchers for decades, but only for laypeople. Experts have escaped similar scrutiny into the factors that influence their views on potential risks, and have been assumed to focus only of the probability and the magnitude of the risk, effectively closing the door to real dialogue with patients and other non-experts. The first three chapters of this thesis present the results of field studies aimed at evaluating the psychometric paradigm among a group of experts who conduct risk evaluation within the pharmaceutical regulatory environment. The fourth chapter, provides results of a multi-criteria decision support tool evaluated within the pharmaceutical regulatory environment and shows that it is feasible to integrate such methods within the existing benefit-risk evaluation process. The two final chapters present an advance on the previous chapter by using a multi-criteria approach to capture preferences for treatment outcomes among patients and among experts (medical assessors) for ‘real’ treatment decisions. From this we can begin to quantify where the expert and the non-expert values on acceptable benefits and risks differ and where they converge. New paths for communication between all stakeholders in the field of medical research can be forged and the concepts of dialogue and shared decision-making realised within the field of pharmaceutical regulation.

M3 - Thesis fully internal (DIV)

SN - 978-94-6182-614-5

PB - University of Groningen

CY - [Groningen]

ER -

The human dimension in the assessment of medicines: Perception, preferences, and decision making in the European regulatory environment

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