scholarly journals Quantitative Benefit–Risk Assessment: State of the Practice Within Industry

2020 ◽  
Author(s):  
Meredith Y. Smith ◽  
Janine van Til ◽  
Rachael L. DiSantostefano ◽  
A. Brett Hauber ◽  
Kevin Marsh
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Life Sciences ◽  
Risk Assessments ◽  
Structured Interviews ◽  
Pilot Studies ◽  
Implementation Challenges ◽  
Regulatory Guidance ◽  
Benefit Risk Assessment ◽  
Regulatory Submissions

Abstract Background Benefit–risk assessments for medicinal products and devices have advanced significantly over the past decade. The purpose of this study was to characterize the extent to which the life sciences industry is utilizing quantitative benefit–risk assessment (qBRA) methods. Methods Semi-structured interviews were conducted with a sample of industry professionals working in drug and/or medical device benefit–risk assessments (n = 20). Questions focused on the use, timing, and impact of qBRA; implementation challenges; and future plans. Interviews were recorded, transcribed, and coded for thematic analysis. Results While most surveyed companies had applied qBRA, application was limited to a small number of assets—primarily to support internal decision-making and regulatory submissions. Positive impacts associated with use included improved team decision-making and communication. Multi-criteria decision analysis and discrete choice experiment were the most frequently utilized qBRA methods. A key challenge of qBRA use was the lack of clarity regarding its value proposition. Championing by senior company leadership and receptivity of regulators to such analyses were cited as important catalysts for successful adoption of qBRA. Investment in qBRA methods, via capability building and pilot studies, was also under way in some instances. Conclusion qBRA application within this sample of life sciences companies was widespread, but concentrated in a small fraction of assets. Its use was primarily for internal decision-making or regulatory submissions. While some companies had plans to build further capacity in this area, others were waiting for further regulatory guidance before doing so.

scholarly journals Benefit–Risk Tradeoffs in Assessment of New Drugs and Devices

Circulation ◽  
2020 ◽  
Vol 142 (20) ◽  
pp. 1974-1988
Author(s):  
Sanjay Kaul ◽  
Norman Stockbridge ◽  
Javed Butler
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Aortic Valve ◽  
Antiplatelet Agents ◽  
The United States ◽  
New Drugs ◽  
Net Benefit ◽  
Nonvalvular Atrial Fibrillation ◽  
Qualitative Approaches ◽  
Benefit Risk Assessment

Balancing benefits and risks is a complex task that poses a major challenge, both to the approval of new medicines and devices by regulatory authorities and in therapeutic decision-making in practice. Several analysis methods and visualization tools have been developed to help evaluate and communicate whether the benefit–risk profile is favorable or unfavorable. In this White Paper, we describe approaches to benefit–risk assessment using qualitative approaches such as the Benefit Risk Action Team framework developed by the Pharmaceutical Research and Manufacturers of America, and the Benefit–Risk Framework developed by the United States Food and Drug Administration; and quantitative approaches such as the numbers needed to treat for benefit and harm, the benefit–risk ratio, and Incremental Net Benefit. We give illustrative examples of benefit–risk evaluations using 4 treatment interventions including sodium glucose cotransporter 2 inhibitors in patients with type 2 diabetes; a direct antithrombin agent, dabigatran, for reducing stroke and systemic embolism in patients with nonvalvular atrial fibrillation; transcatheter aortic valve replacement in patients with symptomatic severe aortic valve stenosis; and antiplatelet agents vorapaxar and prasugrel for reducing cardiovascular events in patients at high cardiovascular risk. Regular applications of structured benefit–risk assessment, whether qualitative, quantitative, or both, enabled by easy-to-understand graphical presentations that capture uncertainties around the benefit–risk metric, may aid shared decision-making and enhance transparency of those decisions.

A Review of the Validity of Juvenile Risk Assessment Across Race/Ethnicity

2018 ◽  
Author(s):  
Christina Campbell ◽  
William Miller
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Ethnic Minorities ◽  
Minority Groups ◽  
Critical Role ◽  
The United States ◽  
Risk Assessments ◽  
Assessment Instruments ◽  
Race Ethnicity ◽  
Racial Ethnic

Juvenile risk assessment instruments have provided juvenile courts with the opportunity to make standardized decisions concerning sentences and intervention needs. Risk assessments have replaced the reliance on professional decision-making practices in which court officials relied on their hunches or previous experience to determine what to do with youth once they became involved in corrections. A primary goal of juvenile risk assessment is to improve case management and help courts focus resources on juveniles who exhibit the greatest intervention needs. Further, juvenile risk assessments play a critical role in estimating which juveniles will likely reoffend by identifying factors that increase the propensity of future offending. Although some researchers believe that the implementation of standardized juvenile risk assessments is a good strategy for reducing biased decision-making for racial/ethnic minorities, other researchers have called into question the extent to which risk assessments overestimate risk for certain juveniles, especially those in minority groups who have a history of being marginalized due to their race, culture, or ethnicity. This article provides an overview of how well juvenile risk assessment instruments predict future delinquency across race and ethnicity. The review suggests that in general, risk assessments do a good job in predicting recidivism across racial/ethnic groups for diverse populations inside and outside the United States. However, there is still some room for improvement concerning the assessment of risk and needs for ethnic minorities. In addition, while there are some studies that do not report the predictive validity of risk assessment scores across race/ethnicity, risk assessments overall seem to be a promising effort to correctly classify and/or identify juveniles who are at greatest risk for future recidivism.

‘Keep Them on the Straight and Narrow’: Understanding, Selecting and Governing Subjects Through Intensive Supervision Units

2020 ◽  
Author(s):  
Garrett Lecoq ◽  
Dale Ballucci ◽  
Dale Spencer
Keyword(s):  
Decision Making ◽  
Criminal Justice ◽  
High Risk ◽  
Focus Groups ◽  
Risk Assessments ◽  
Structured Interviews ◽  
Monitoring Techniques ◽  
Intensive Supervision ◽  
Actuarial Risk

Abstract Drawing from focus groups and semi-structured interviews, this paper examines decision-making practices and monitoring techniques of Canadian Intensive Supervision Units (ISUs) managing high-risk individuals in the community. We argue that ISU subjects are hyper-individualized through their unique conditions of release, contesting notions that actuarial risk assessments have eclipsed individual understandings of dangerousness in risk, correctional and policing literature. Using Foucault’s disciplinary, pastoral and confessional dispositifs, we highlight how ISU agents make subjects active participants in their own punishment. Moreover, we illustrate how dispositifs not only allow ISU agents to understand, select and govern subjects but also, more problematically, transform subjects into ostensibly dangerous entities reifying and necessitating escalating criminal justice interventions under auspices of protecting the community from potential—not guaranteed—harm.

scholarly journals New Elements To Consider When Modeling the Hazards Associated with Botulinum Neurotoxin in Food

2015 ◽  
Vol 198 (2) ◽  
pp. 204-211 ◽  
Author(s):  
Adaoha E. C. Ihekwaba ◽  
Ivan Mura ◽  
Pradeep K. Malakar ◽  
John Walshaw ◽  
Michael W. Peck ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Food Safety ◽  
Health Hazard ◽  
Management Strategies ◽  
Rare Condition ◽  
Risk Assessments ◽  
Content Type ◽  
Hazard Management ◽  
Cranial Nerve Palsies

Botulinum neurotoxins (BoNTs) produced by the anaerobic bacteriumClostridium botulinumare the most potent biological substances known to mankind. BoNTs are the agents responsible for botulism, a rare condition affecting the neuromuscular junction and causing a spectrum of diseases ranging from mild cranial nerve palsies to acute respiratory failure and death. BoNTs are a potential biowarfare threat and a public health hazard, since outbreaks of foodborne botulism are caused by the ingestion of preformed BoNTs in food. Currently, mathematical models relating to the hazards associated withC. botulinum, which are largely empirical, make major contributions to botulinum risk assessment. Evaluated using statistical techniques, these models simulate the response of the bacterium to environmental conditions. Though empirical models have been successfully incorporated into risk assessments to support food safety decision making, this process includes significant uncertainties so that relevant decision making is frequently conservative and inflexible. Progression involves encoding into the models cellular processes at a molecular level, especially the details of the genetic and molecular machinery. This addition drives the connection between biological mechanisms and botulism risk assessment and hazard management strategies. This review brings together elements currently described in the literature that will be useful in building quantitative models ofC. botulinumneurotoxin production. Subsequently, it outlines how the established form of modeling could be extended to include these new elements. Ultimately, this can offer further contributions to risk assessments to support food safety decision making.

Initiating and Managing Risk Assessments within a Risk Analysis Framework: FDA/CFSAN'S Practical Approach

2004 ◽  
Vol 67 (9) ◽  
pp. 2058-2062 ◽  
Author(s):  
ROBERT L. BUCHANAN ◽  
SHERRI DENNIS ◽  
MARIANNE MILIOTIS
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Risk Management ◽  
Risk Analysis ◽  
Risk Assessments ◽  
Analysis Framework ◽  
Regulatory Decision ◽  
Managing Risk ◽  
Risk Managers ◽  
The U.S

Management of risk analysis involves the integration and coordination of activities associated with risk assessment, risk management, and risk communication. Risk analysis is used to guide regulatory decision making, including trade decisions at national and international levels. The U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition (CFSAN) formed a working group to evaluate and improve the quality and consistency of major risk assessments conducted by the Center. Drawing on risk analysis experiences, CFSAN developed a practical framework for initiating and managing risk assessments, including addressing issues related to (i) commissioning a risk assessment, (ii) interactions between risk managers and risk assessors, and (iii) peer review.

scholarly journals Evolving Acceptance and Use of RWE for Regulatory Decision Making on the Benefit/Risk Assessment of a Drug in Japan

2021 ◽  
Author(s):  
Kinue Nishioka ◽  
Tomomi Makimura ◽  
Akihiro Ishiguro ◽  
Takahiro Nonaka ◽  
Mitsune Yamaguchi ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Regulatory Decision ◽  
Benefit Risk Assessment

scholarly journals Acknowledging Children’s Voice and Participation in Family Courts: Criteria that Guide Western Australian Court Consultants

2017 ◽  
Vol 5 (3) ◽  
pp. 155-163 ◽  
Author(s):  
Vicki Banham ◽  
Alfred Allan ◽  
Jennifer Bergman ◽  
Jasmin Jau
Keyword(s):  
Decision Making ◽  
Western Australia ◽  
Family Court ◽  
Structured Interviews ◽  
Circuit Court ◽  
Regulatory Guidance ◽  
Family Courts ◽  
Rights Of The Child ◽  
Australian Family ◽  
The Family

The Australian family courts introduced Child Inclusive Conferencing after the country adopted the United Nations Convention on the Rights of the Child. The legislation governing these conferences is minimalistic but the Family Court Consultants in the Family Court of Australia and the Federal Circuit Court have well-developed and documented guidelines. The Family Court of Western Australia is, however, a separate entity and in the absence of regulatory guidelines its Family Consultants developed their own process and criteria. This model is unique, in Australia at least, because it has been organically developed by the practitioners providing the Child Inclusive Conferences with very little, if any, statutory and regulatory guidance. This model therefore serves as an example of how practitioners think child inclusive services should be offered. The model is, however, not documented and the aim of this study was to understand and document Family Consultants’ decision making regarding if and when they will conduct a Child Inclusive Conference in the Family Court of Western Australia. Ten Family Consultants were interviewed using semi-structured interviews. A thematic analysis was conducted on the transcripts of the interviews identifying 12 themes. Overall the data suggested that Family Consultants take into account a range of criteria and although they were very cognisant of the importance for the child to be engaged in decision making they noted specific challenges regarding how they could use Child Inclusive Conferencing to do this. These findings provide a basis for the development of regulations that ensure that Child Inclusive Conferences are used optimally to improve the inclusion of children in the family court procedures in Western Australia and potentially elsewhere. Further research is, however, necessary before such regulations can be finalised.

Risk assessment

2018 ◽  
pp. 139-152
Author(s):  
Maria Flynn ◽  
Dave Mercer
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Nursing Care ◽  
Assessment Tools ◽  
Risk Assessments ◽  
Care Services ◽  
Risk Assessment Tools ◽  
Healthcare Environments ◽  
Managing Risk ◽  
Routine Procedures

General adult nurses work with people in hospitals, hospices, community care services, and people’s homes. Irrespective of the place of work, there will be many routine procedures which are an important part of reducing risk to people and organizing subsequent nursing work. It is recognized that all organizations will have different risk assessment tools and recording procedures, but there are generic principles of safety which underpin all these tools. An important aspect of nursing decision-making and practice is understanding and managing risk, and factoring risk management into the planning and delivery of nursing care. This chapter considers the broad principles of risk assessments which are widely used across healthcare environments.

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