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Clinical Trial Simulation based on Proportional Odds Model and D-optimal Design

ZHENG Dan1,ZHU Ling,LIU Yajie,SHI Xinling(1.Electronical Engineering Department,Information School,Yunnan University,Kunming 650091,China)  
To introduce the clinical trial simulation based on proportional odds model.Taking naratriptan as example,which is a novel agonist for the acute treatment of migraine,we adopted the method of D-optimal design to simulate the drug clinical trail of naratriptan.We adopted proportional odds model and analysed different factors such as time and does how to impact Pain Relief(PR).Then,the D-optimal design was used to maximize the determinant of Fisher information matrix(FIM) and compared the clinical trial simulated results.Finally more reasonable dose and time of the designs were obtained.The curve of the PR probability expressed PR trend directly,reflecting administration dose and time on the impact of PR.According to the simulated results,we found that there was a delay of the effect with respect to the plasma concentration in "effect" compartment and the probability of having a specific Pain Relief(PR) score depended on different facts such as dose,the effect sampling time and model parameters.Clinical trial simulation is a useful tool for the new drug development and it can be used for the quantitative assessment of the controllable factors to the effect of treatment.
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