Objectives: Balancing benefits and risks through the drug life cycle has been discussed for many decades. The objective of this study was to review the processes and tools currently proposed for benefit-risk assessment of medicinal drugs. It aimed to establish scientific and efficient drug safety management system based on the synthetic analysis of benefit-risk evidence. Methods: We conducted a review of exiting literatures published by regulatory agencies or initiatives. Not only quantitative methodologies but also qualitative method were compared to understand their key characteristics for the benefit and risk assessment of drugs. Results: Recently, benefit-risk assessments have more structured approaches to decision making as part of regulatory science. Regulatory agencies such as European Medicines Agency, FDA have prepared plans to apply benefit-risk assessment to regulatory decision making. Also many initiatives such as IMI (Innovative Medicine Initiative) have conducted research and published reports about benefit-risk assessment. For benefit-risk assessment, four kinds of methods are necessary. Frameworks such as BRAT (Benefit Risk Action Team) framework, PrOACT-URL provide guidance for the whole process of decision-making. Metrics are measurements of risk benefit. The estimation techniques are methods to synthesis and combine evidences from various sources. The utility survey techniques are necessary to explicit preferences of various outcome from stakeholders. Conclusion: There is the lack of widely accepted, validated model for benefit-risk assessment. Nor there is an agreement among academia, industry, and government on methods for the quantitative valuation. It is also limited by available evidence and underlying assumptions. Nevertheless, benefit-risk assessment is fundamental to improve transparency, consistency and predictability for decision making through the structured systematic approaches.
Kim Myounghyun;Lim Youngwook;Park Jongyun;Shin Dongchun;Yang Jihyung;Boo Minjung
Environmental Analysis Health and Toxicology
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v.20
no.2
s.49
/
pp.97-108
/
2005
This study is to estimate differences, relationships and related factors of environmental risk perception and perceived benefit among residents and workers. A self-administered questionnaire survey using a structured instrument was carried out to residents and workers in industrial area during April, 2002. Total number of participants were 657 including 329 residents and 328 workers. Participants assessed environmental risk perception, self- assessed knowledge, trust in authorities and perceived benefit associated with 10 products manufactured in industrial area. There were difference in environmental risk perception, knowledge and trust in authorities and perceived benefit among residents and workers. Especially, trust in authorities and perceived benefit were statistically significant difference among residents and workers. Inverse relationships between environmental risk perception and perceived benefit have been observed for different products. In other words, the greater the perceived benefit, the lower the perceived risk, and vice versa. Factors mostly associated with participant's characteristics of environmental risk perception were age. marriage status (workers), education level (workers). There was statistically significant difference. Perceived benefit was statistically significant difference with sex, marriage status, residence duration, education level (workers). Related factors of environmental risk perception among residents and workers were age, trust in authorities. And factors affecting the perceived benefit were sex, age, education level (workers), and trust in authorities (workers). According to the results, people having high trust in the authorities perceived less risks than people having low in the authorities. To improve the communication of risk information, further study focus on assessment of experts, government and stakeholder in industrial area. Methodologies of this study can be used as the basis for investigating the structure of public perception of environmental products risks and benefit, designing a public information and risk communication program, and developing policy actions to improve acceptance.
Moon, Heekang;Choo, Ho Jung;Park, Hye Sun;Baek, Eunsoo
Journal of the Korean Society of Clothing and Textiles
/
v.37
no.2
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pp.159-173
/
2013
This research investigates the mechanism of ethical fashion consumption by examining the effects of benefit and risk perception on ethical fashion consumption attitudes and behavioral intention. To test the hypotheses, 300 female consumers between the ages of 20 and 49 were invited as study participants. The reliability and the validity of multi-item constructs were tested by Confirmatory Factor Analysis. The hypotheses were tested by utilizing Structural Equation Analysis and hierarchical multiple regression analysis. The benefit perception of ethical consumption was composed of three benefit types, which were altruistic benefit, social image benefit, and self-oriented benefit. Benefit perception, except social image benefit, had significant effects on consumer attitudes towards ethical fashion consumption; similarly, benefit perception had significant effects on behavioral intention (except self-oriented benefit) which had an effect on behavioral intention only when it was mediated by attitudes. Further analysis was conducted to understand the reason for the weak relationship between attitudes and behavioral intention. Financial and performance risk perceptions were tested for the moderating roles of attitudes and behavioral intention; subsequently, only financial risk interacted with attitudes and showed that the positive effects of attitudes on behavioral intention were weakened by a high financial risk perception. Performance risk had a main effect on behavioral intention independent of attitudes. Managerial implication and future study directions are also discussed.
The benefits of pesticides in improving the food quantity and quality requirements for an increasing world population are significant, and they can be described in agronomic, economic and social terms. The risks are assessed from the hazards which are likely to occur in practice ; the hazards are defined by the toxicity of the pesticide to non-target organisms at various exposure levels. There are ways of reducing the risks (mainly by reducing exposure in practice) and improving the benefits of pesticides ; these are known as risk management and benefit management respectively. The overall risk-benefit assessment is facilitated if each component can be expressed in financial terms, but it must be made nationally or locally on a sound technical basis against the prevailing agronomic, socio-economic and political circumstances. Paraquat is used to illustrate the risk-benefit assessment process in general terms, and the conclusion is that the benefits greatly outweigh the risks. It is important to keep the risks of pesticides in perspective with those associated with other naturally occurring chemicals in our diet and with other everyday aspects of life. In an overall context, the pesticide risk is small.
The purose of this study was to investigate the effect of clothing image, benefit sought, perceived risk, demographic and consumer's characteristics on the Purchase Intention of Saenghwal-Hanbok. The questionnaire was administered to 227 women in Seoul Data were analysed by factor analysis, correlation and multipleregression. The resets of this study were as follows: 1. The clothing images of Saenghwal-Hanbok were composed of dignified, comfortable, conservative and innovative dimensions. The benefits sought of Saenghwal-Hanbok were identified to traditional aethetics, contemporary aethetics, comfortability The perceived risk of Saenghwal-Hanbok was the only risk on the negative viewpoint of others. 2. The images of Saenghwal-Hanbok with the exception of innovative image have influenced on the benefit sought and the perceived risk of Saenghwal-Hanbok. 3. The positive effects of benefits sought iud negative effect of perceived risk ell the purchase intention of Saenghwal-Hanbok were found. There were also the significant effects of demographic and consumer's characteristics on the clothing image, benefit sought, perceived risk.
The quantitative evaluation method of the safety management cost was suggested to prevent a gas accident as a major industrial accident. In a gas governor station, process risk assessments such as the fault tree analysis(FTA) and the consequence analysis were performed. Based on process risk assessments, potential accident costs were estimated and the cost-benefit analysis(CBA) was performed. From the cost-benefit analysis for five classification items of safety management cost, the order of the cost/benefit ratio was estimated.
The main objective of this study is to investigate the moderating roles of the competitor's pricing strategy and the degree of consumer's risk-aversion on perceived risk and perceived benefit in responding to price increases and package downsizing. Based on Prospect Theory, several prior researches find that consumers perceive increased price as more loss than package downsizing and perceive package downsizing as more benefit than increased price. We extend these behavioral economics approach using the reference effect of competitor's pricing strategy. We focus on consumer heterogeneity on risk-aversion, measure the degree of consumer's risk-aversion, and divide the consumers into two groups of high levels of risk-aversion vs. low levels of risk-aversion. We find that the firm's pricing strategies of both price increases and package downsizing do not significantly influence the perceived benefit for relatively low risk-aversion consumers. We find that when the firm reduce the package size, relatively high risk-aversion consumers perceived more benefit and had higher purchase intention compared to price increases. We also find that the competitor's pricing strategies do not significantly influence the consumer's response for relatively low risk-aversion consumers. For relatively high risk-aversion consumers, they perceived more loss when the firm has different pricing strategy from the competitor's.
The Journal of Economics, Marketing and Management
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v.6
no.4
/
pp.51-64
/
2018
Purpose - This study is intended to look into the influences of restaurant consumers' e-WOM information communication on product perception risk, benefit and WOM effect. Research design, data, and Methodology - To achieve this, a survey was empirically carried out to 426 restaurant consumers. Results - The findings are as follows. First, the influence of e-WOM on product perception risk showed that WOM information sender characteristics, WOM information recipient characteristics and online community had a statistically significant positive influence on product perception risk. Second, the influence of e-WOM on product risk benefit showed that WOM information sender characteristics, WOM information recipient characteristics and online communication had a statistically significant positive influence on product risk benefit. Third, WOM risk perception had a statistically significant positive influence on WOM acceptance. Fourth, WOM risk benefit had a statistically significant positive influence on WOM effect. Conclusions - As for the above-mentioned findings, the communication between e-WOM sender and recipient had a positive influence on the product evaluation and attitude change in the restaurant industry, and the WOM effect had an influence on the financial performance and non-financial performance. The communication attaches importance to a direct using and tasting experience due to the nature of restaurant industry when it is simultaneously performed as a positive mechanism between sender and recipient through each channel of these factors. But the e-WOM culture can lead to the WOM effect when both sender and recipient share the persuasive communicability in reality that diversifies communication methods, having a positive influence on the management performance.
Journal of Family Resource Management and Policy Review
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v.9
no.2
/
pp.145-161
/
2005
This study was to examine whether the hedonic and utilitarian shopping values were expressed in shopping experience among the undergraduates and how the consumers with different shopping values vary in the perception of credit cards' benefit and risk. The 215 undergraduates in Seoul were surveyed. The results indicated that undergraduates were divided into hedonic shoppers and utilitarian shoppers according to their shopping value and that the perception of credit cards' benefit and risk was explained by the four factors including the increased cost, the removing the immediate need for money, the additional service and benefits, and the overspending and credit crime. The overspending and credit crime as one of the risk factors was affected by the types of shopping values.
Md Shafiqul Islam;Swapnil Roy;Sadia Lena Alfee;Animesh Pal
Nuclear Engineering and Technology
/
v.55
no.12
/
pp.4617-4627
/
2023
Public perception of benefit over risk is the de facto factor in planning, construction, operation, halting, or phase-out of a nuclear power plant in any country. Even if there are multiple pathways of perceiving risk/benefit among different stakeholders, the perception of nuclear and non-nuclear groups needs to be individually tracked to help understand sectoral influence. Related studies were basically performed between the STEM (Science, Technology, Engineering, and Mathematics) and non-STEM groups. However, there are no such studies between the nuclear and non-nuclear groups. This study investigated the risk-benefit perceptions between the nuclear group (N = 102) and the non-nuclear group (N = 467) using survey data to measure their stake and identify the underlying factors by validating the hypotheses, through descriptive analysis, and structural equation modeling (SEM). Results showed that risk perception is significantly high in the non-nuclear group (as the P-value is > 0.001 to <0.01) while the benefit perception is slightly low in the nuclear group (as the P-value is > 0.01 to <0.05). The non-nuclear group was significantly influenced by risk perception due to a lack of involvement in nuclear activities. Notably, the nuclear group is less interactive in disseminating nuclear energy benefits to the non-nuclear group. Surprisingly, misperceptions and lack of confidence about the benefits of nuclear energy also exist in the nuclear group. The study emphasizes debunking nuclear myths in the nuclear and non-nuclear groups through meaningful interactions and demands effective public awareness-building programs by competent authorities for the growth of the nuclear industry.
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