Risk Attitudes and Personality Traits Predict Perceptions of Benefits and Risks for Medicinal Products: A Field Study of European Medical Assessors

Beyer, Andréa; Fasolo, Barbara; Graeff, de Pieter; Hillege, Hans L.

doi:10.1016/j.jval.2014.10.011

Cited by 26 publications

(33 citation statements)

References 33 publications

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“…This questionnaire was designed to assess risk perceptions in the pharmaceutical industry and allied healthcare sectors, and is analogous to the Beyer regulatory authority study (Beyer et al, 2015) described later in this manuscript. The aim is to investigate go/no-go judgments in discovery and medicine development in order to evaluate the influence of personality, experience as well as demographic traits on decision making (Cowlrick et al, 2011).…”

Section: Resultsmentioning

confidence: 99%

“…Overall, the tool assesses only 3 of the 10 QDMPs relating to evaluation, namely QDMP 4 (evaluate internal/external influences/biases), 6 (consider uncertainty), and 7 (re-evaluate as new information becomes available). Due to the stepwise nature of the cases, this tool offers the potential to understand whether individuals re-evaluated their decision making with new information, which was not possible in the single step decision study by Beyer et al (2015). …”

Section: Resultsmentioning

confidence: 99%

“…The authors did not describe how the method used was developed, compared with the Beyer et al (2015) study in which validated tools were used, but nevertheless, this technique was less time intensive.…”

Section: Resultsmentioning

confidence: 99%

“…The two main objectives of the study were to describe the distribution of risk attitudes among medical assessors within EMA and to measure their personality traits and cross-domain risk attitudes (Beyer et al, 2015). …”

Section: Resultsmentioning

confidence: 99%

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Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature

et al. 2017

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Introduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better quality decision making. This could be addressed by formally evaluating the quality of decision-making process within those organizations. The aim of this literature review was to identify current techniques (tools, questionnaires, surveys, and studies) for measuring the quality of the decision-making process across the three stakeholders.Methods: Using MEDLINE, Web of Knowledge, and other Internet-based search engines, a literature review was performed to systematically identify techniques for assessing quality of decision making in medicines development, regulatory review, and HTA. A structured search was applied using key words and a secondary review was carried out. In addition, the measurement properties of each technique were assessed and compared. Ten Quality Decision-Making Practices (QDMPs) developed previously were then used as a framework for the evaluation of techniques identified in the review. Due to the variation in studies identified, meta-analysis was inappropriate.Results: This review identified 13 techniques, where 7 were developed specifically to assess decision making in medicines' development, regulatory review, or HTA; 2 examined corporate decision making, and 4 general decision making. Regarding how closely each technique conformed to the 10 QDMPs, the 13 techniques assessed a median of 6 QDMPs, with a mode of 3 QDMPs. Only 2 techniques evaluated all 10 QDMPs, namely the Organizational IQ and the Quality of Decision Making Orientation Scheme (QoDoS), of which only one technique, QoDoS could be applied to assess decision making of both individuals and organizations, and it possessed generalizability to capture issues relevant to companies as well as regulatory authorities.Conclusion: This review confirmed a general paucity of research in this area, particularly regarding the development and systematic application of techniques for evaluating quality decision making, with no consensus around a gold standard. This review has identified QoDoS as the most promising available technique for assessing decision making in the lifecycle of medicines and the next steps would be to further test its validity, sensitivity, and reliability.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature

et al. 2017

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“…Finally, it needs to have further research about the relationship between personality traits and perceived risk and benefit. For medicinal products, Beyer et al (2015) surveyed 75 European medical assessors for the research of risk attitudes and personality traits which predict perceptions of benefits and risks for medicinal products. Results presented that an increase in the conscientiousness score estimated an increase in the perception of the drug's benefit.…”

Section: The Big Five and Perceived Risk And Uncertaintymentioning

confidence: 99%

Personality Traits, Perceived Risk, Uncertainty, and Investment Performance in Vietnam

Phung¹,

Khương²

2017

Glob Bus Financ Rev

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A B S T R A C TThe study explored the impact of personality traits, perceived risk, and perceived uncertainty on investment performance of individual investors trading on the Vietnam stock market. The study conducted in-depth interviews, a pilot study, and a survey distributed to 430 individual investors. Results showed that Conscientiousness and perceived uncertainty directly affected investment performance. Openness, Extraversion, and Neuroticism indirectly influenced investment performance through the mediation of perceived uncertainty. This study suggested that individual investors should perceive uncertain situations when they invest in securities. Especially, investors who are prone to Openness, Extraversion, and Neuroticism must pay attention to uncertainty before they make investing decisions. Since Agreeableness did not affect investment performance, those who are dominant to this trait should have prudent considerations for equity investment decisions.

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Quantifying Preferences in Drug Benefit‐Risk Decisions

Tervonen

Angelis

Hockley

et al. 2019

Clin Pharma and Therapeutics

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Benefit‐risk assessment is used in various phases along the drug lifecycle, such as marketing authorization and surveillance, health technology assessment (HTA), and clinical decisions, to understand whether, and for which patients, a drug has a favorable or more valuable profile with reference to one or more comparators. Such assessments are inherently preference‐based as several clinical and nonclinical outcomes of varying importance might act as evaluation criteria, and decision makers must establish acceptable trade‐offs between these outcomes. Different healthcare stakeholder perspectives, such as those from patients and healthcare professionals, are key for informing benefit‐risk trade‐offs. However, the degree to which such preferences inform the decision is often unclear as formal preference‐based evaluation frameworks are generally not used for regulatory decisions, and, if used, rarely communicated in HTA decisions. We argue that for better decisions, as well as for reasons of transparency, preferences in benefit‐risk decisions should more often be quantified and communicated explicitly.

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Risk Attitudes and Personality Traits Predict Perceptions of Benefits and Risks for Medicinal Products: A Field Study of European Medical Assessors

Abstract: Medical assessors perceive the benefits and risks of medicines via a complex interplay of the medical situation, their personality traits and even their gender. Further research in this area is needed to determine how these potential biases are managed within the regulatory setting.

Cited by 26 publications

References 33 publications

Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature

Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature

Personality Traits, Perceived Risk, Uncertainty, and Investment Performance in Vietnam

Quantifying Preferences in Drug Benefit‐Risk Decisions

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