Visualization of Benefit–Risk Assessment in Medical Products with Real Examples

2017 ◽  
pp. 197-231
Author(s):  
Shihua Wen ◽  
Weili He ◽  
Scott Evans ◽  
Haijun Ma ◽  
Christy Chuang-Stein ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Medical Products ◽  
Benefit Risk Assessment

Trends and Recent Progress in Benefit-Risk Assessment Planning for Medical Products and Devices

2021 ◽  
pp. 285-315
Author(s):  
Lisa R. Rodriguez ◽  
Cheryl Renz ◽  
Brian Edwards ◽  
William Wang
Keyword(s):  
Risk Assessment ◽  
Recent Progress ◽  
Medical Products ◽  
Benefit Risk Assessment

scholarly journals Multi-Criteria Benefit-Risk Assessment of Biological Agents in the Treatment of Moderate to Severe Psoriais: A Stochastical Approach

2013 ◽  
Vol 16 (7) ◽  
pp. A727
Author(s):  
B.S. Riveros ◽  
I. Rotta ◽  
M. Garcia ◽  
T.T. Souza ◽  
R.R. Godoy ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Biological Agents ◽  
Benefit Risk Assessment

scholarly journals Benefit–Risk Assessment of the French Surveillance Protocol of Apparently Healthy Biting Dogs and Cats for Human Rabies Prevention

2021 ◽  
Vol 8 (7) ◽  
pp. 132
Author(s):  
Guillaume Crozet ◽  
Tiffany Charmet ◽  
Florence Cliquet ◽  
Emmanuelle Robardet ◽  
Barbara Dufour ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Traffic Accidents ◽  
Scenario Tree ◽  
Human Rabies ◽  
Post Exposure Prophylaxis ◽  
Policy Makers ◽  
Benefit Risk Assessment ◽  
Surveillance Protocol ◽  
Exposure Prophylaxis ◽  
Apparently Healthy

In France, apparently healthy dogs and cats that bite humans must undergo an observation period of 15 days with three veterinary visits to ascertain that they remain healthy, indicating that no zoonotic transmission of rabies virus occurred via salivary presymptomatic excretion. This surveillance protocol is mandatory for all pets that have bitten humans, despite France’s rabies-free status in non-flying mammals (i.e., a very low rabies risk). In this context, we aimed to perform a benefit–risk assessment of the existing regulatory surveillance protocol of apparently healthy biting animals, as well as alternative surveillance protocols. A scenario-tree modelling approach was used to consider the possible successions of events between a dog or cat bite and a human death attributed to either rabies or to lethal harm associated with the surveillance protocol (e.g., lethal traffic accidents when traveling to veterinary clinics or anti-rabies centers). The results demonstrated that the current French surveillance protocol was not beneficial, as more deaths were generated (traffic accidents) than avoided (by prompt post-exposure prophylaxis administration). We showed here that less stringent risk-based surveillance could prove more appropriate in a French context. The results in this study could allow policy-makers to update and optimize rabies management legislation.

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