Benefit–Risk Evaluation Using a Framework of Joint Modeling and Joint Evaluations of Multiple Efficacy and Safety Endpoints

2017 ◽  
pp. 175-196 ◽  
Author(s):  
Weili He ◽  
Bo Fu
Keyword(s):  
Risk Evaluation ◽  
Joint Modeling ◽  
Efficacy And Safety

scholarly journals Decision Criteria During Joint Modelling of Efficacy and Safety With MCP-Mod

2020 ◽  
Vol 10 (1) ◽  
pp. 79
Author(s):  
Caroline Kellner ◽  
Lieven Nils Kennes
Keyword(s):  
Phase Ii ◽  
Joint Modeling ◽  
Dose Finding ◽  
Proof Of Concept ◽  
Efficacy And Safety ◽  
Decision Criteria ◽  
Phase Ii Trials ◽  
Joint Modelling ◽  
Significance Level ◽  
Phase Ii Studies

MCP‐Mod has been established as analysis method for investigating the dose‐response (DR) relationship and dose finding in clinical Phase II trials. While most work on MCP-Mod focusses on the efficacy DR relationship, in 2015, Tao, Lin, Pinheiro and Shih (2015) extended MCP-Mod to the joint modelling of efficacy and safety endpoints in “Dose Finding Method in Joint Modeling of Efficacy and Safety Endpoints in Phase II Studies”. Their proposed algorithm defines several decision criteria, which majorly impact results or even terminate the algorithm. This viewpoint investigates the robustness of two of these decision criteria. While the criterion on the relationship between the maximum safety dose and minimum effective dose is reasonable and robust, there exist some advantages applying a more generous criterion to establish proof of concept for safety. Increasing the proposed significance level in establishing proof of concept for the safety DR relationship, helps to identify non-flat safety DR relationships which ultimately improves final estimation of the optimal dose.

The efficacy and safety of long-term administration of alpha-interferon and lamivudine in patients with chronic hepatitits B

2001 ◽  
Vol 120 (5) ◽  
pp. A572-A572
Author(s):  
F JABOLI ◽  
E RODA ◽  
C FABBRI ◽  
S MARCHETTO ◽  
F FERRARA ◽  
...  
Keyword(s):  
Alpha Interferon ◽  
Efficacy And Safety ◽  
Term Administration
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