临床数据自查政令下风险偏好型企业参与的多元博弈分析

Analysis of risk-love-type manufacturer-involved multiplayer game under the regulation of self-check on clinical data

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。

Objective： To analyze the likely actions of risk-love-type manufacturers in response to the regulation No. 117 issued by China Food and Drug Administration（ CFDA） in 2015 for self-check on submmitted clinical data and put forward suggestions on CFDA＇s corresponding actions in order to manage the integrity and authenticity of clinical data. Methods： The models of sequential game and mixed strategy game were used to analyze the payoff of each side in the game according to the game theory,and the solution of Nash Equilibrium of CFDA＇s inspection and manufacturer＇s fabrication was found. Results： The solution of Nash Equilibrium revealed that the probability of collusive fabrication was in proportion to the payoff of CFDA＇s inspection,but inversely proportional to the probability of check-fabrication-out in CFDA＇s inspection,and also inversely proportional to the punishment when check-fabrication-out. Conclusion： Regulation No. 117 functions positively in drug clinical trial administration,meanwhile,enhanced inspection ability of CFDA or heavier punishment are supposed to reduce manufacturers＇ intentional fabrication.