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目的:在国家食品药品监督管理总局颁布的2015年117号公告的背景下,为规范新药注册审评中企业提交的临床试验数据的完整性与真实性,分析风险偏好型企业可能采取的行为以及政府的对应策略。方法:应用博弈理论,采用序贯博弈和混合战略博弈的模型分析,讨论各情况下博弈各方的收益,求得政府检查与企业造假的纳什均衡解。结果:纳什均衡解揭示了合谋造假的概率与政府检查所支付的成本成正比,与政府在检查中查出造假的概率成反比,因造假被查出而产生的损失加大,则合谋造假的概率会变小。结论:117号公告对药物临床试验的规范将起到积极作用,同时提高政府检查能力是遏制企业主观造假的有效途径。
Objectives: To standardize the completeness and authenticity of clinical trial data submitted by enterprises in the review of new drug registration in the context of Announcement No. 117 of 2015 issued by the State Food and Drug Administration, and to analyze the possible behaviors of risk-preference enterprises and Government’s corresponding strategy. Methods: By using the game theory, the model analysis of sequential game and mixed strategy game is used to discuss the benefits of all parties involved in the game and to obtain the Nash equilibrium solution of government inspection and business fraud. Results: The Nash equilibrium shows that the probability of counterfeiting is proportional to the cost paid by the government inspection, inversely proportional to the probability of the government detecting the fraud in the inspection, and the loss resulting from the detection of the fraud is increased, the conspiracy to fake The probability will be smaller. Conclusion: Bulletin No. 117 will play an active role in the standardization of clinical trials of drugs, meanwhile, improving government inspection capability is an effective way to curb the subjective fraud of enterprises.