基于连续重新评估方法寻找药物的最大安全剂量

Maximum safe dose of drug based on continuous reassessment method

目的建立在药物临床试验阶段确定药物最大安全剂量的方法。方法利用连续重新评估的方法,充分利用已有的试验数据,及时更新有关参数,同时结合目前多元比较中很流行的小样本似然比率方法,从而得出最佳的答案。结果从模拟结果来看,该方法效果很好。结论目前使用的方法是根据事前的标准,由既定方法和计算公式得出药物的最大安全剂量,不能根据最新的试验数据及时调整模型参数,因此得到的结果往往不是最佳。本方法建立的确定药物最大安全剂量方法能够弥补这一缺点,更为准确。

Objective To evaluate the maximum safe dose of drug in clinical trials phase. Methods Continual reassessment method was used to update the model parameters continually according to previous trial data. When this method was applied, it was also combined with currently popular small-sample odd rate method. Results The back simulation results indicated that our method has very good effect in practical. Conclusion The current method is taking multiple medication trials based on simple prior standards and calculating the maximum safe dose. A disadvantage of this method is that it doesn’t use the latest trial data to update the model parameters in time, so the answer is often not the best one. The new method is more accurate and could redeem this defect.