scholarly journals Patient representatives' contributions to the benefit-risk assessment tasks of the European Medicines Agency scientific committees

2014 ◽  
Vol 78 (6) ◽  
pp. 1248-1256 ◽  
Author(s):  
Rosemarie D. L. C. Bernabe ◽  
Ghislaine J. M. W. van Thiel ◽  
Johannes van Delden
Keyword(s):  
Risk Assessment ◽  
European Medicines Agency ◽  
Assessment Tasks ◽  
Benefit Risk Assessment ◽  
Patient Representatives

scholarly journals Systematic benefit-risk assessment for buprenorphine implant: a semiquantitative method to support risk management

2020 ◽  
Vol 25 (6) ◽  
pp. 199-205 ◽  
Author(s):  
Vicki Osborne ◽  
Miranda Davies ◽  
Debabrata Roy ◽  
Francesco Tescione ◽  
Saad A W Shakir
Keyword(s):  
Risk Assessment ◽  
Risk Profile ◽  
European Medicines Agency ◽  
Number Needed To Treat ◽  
The European Union ◽  
Opioid Use ◽  
Sublingual Buprenorphine ◽  
Benefit Risk Assessment ◽  
License Application ◽  
Reduced Risk

BackgroundPrior to approval in the European Union, a systematic benefit-risk assessment was required to compare buprenorphine implant to sublingual buprenorphine as part of the license application to the European Medicines Agency.ObjectiveThe Benefit-Risk Action Team framework was used to describe the overall benefit-risk of buprenorphine implant in comparison to sublingual buprenorphine.Study selection/methodsA value tree of key benefits and risks related to the implant formulation of buprenorphine was constructed. Risk differences (RD) or reporting ORs (ROR) and corresponding 95% CIs were calculated for each outcome, along with the number needed to treat and number needed to harm. Swing weighting was assigned to outcomes and the weighted net clinical benefit (wNCB) was calculated.FindingsKey benefits assessed: reduced risk of illicit opioid use (RD=0.09, 95% CI 0.01 to 0.17), reduced risk of misuse and diversion (ROR=0.13, 95% CI 0.02 to 0.94), improved compliance and convenience (RD=0.20) and quality of life measures (RD=0.03). Key risks assessed: clinically significant implant breakage (RD=0.01, 95% CI 0.00 to 0.01), migration/missing implant (RD=0.01, 95% CI 0.00 to 0.02), infection at insertion/removal site (RD=0.08, 95% CI 0.03 to 0.12) and implant-related allergic reaction (RD=0.07, 95% CI 0.03 to 0.11). The wNCB for buprenorphine implant was 4.96, which suggests a favourable benefit-risk profile.ConclusionsThe benefit-risk profile of buprenorphine implant is considered favourable in comparison to sublingual buprenorphine, based on this semiquantitative analysis using available data. Further data from real-world use on benefits and risks should be used for ongoing monitoring of the benefit-risk profile of buprenorphine implants in the postmarketing setting.

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.

Patient-centered benefit-risk assessment in duchenne muscular dystrophy

2017 ◽  
Vol 55 (5) ◽  
pp. 626-634 ◽  
Author(s):  
Ilene L. Hollin ◽  
Holly L. Peay ◽  
Susan D. Apkon ◽  
John F.P. Bridges
Keyword(s):  
Risk Assessment ◽  
Duchenne Muscular Dystrophy ◽  
Muscular Dystrophy ◽  
Patient Centered ◽  
Benefit Risk Assessment
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