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1总则1.1 设计方案 新药研究必须根据“重复、对照、随机、均衡”的原则,事先制定研究方案,临床研究方案应经伦理委员会批准,实施中如需变更,应经批准,并在总结报告中反映变更情况和理由,基础研究也应有实验设计方案备查.1.2 可比性分析 对于处理前的各组数据必须进行可比性分析.临床研究中,可用病例情况分析进行统计对比.基础研究中,应以用药前数据进行组间显著性检验,如在统计学上不拒绝各组来自同一总体(P>0.05),可认为可比性合格.
1 General Provisions 1.1 Design New drug research must be based on the principle of “repeat, control, random, balanced”, the prior development of research programs, clinical research programs should be approved by the Ethics Committee, the implementation of any changes, should be approved and in the final report Reflect changes and reasons, basic research should also have experimental design for future reference.1.2 comparability analysis For each group before treatment data must be comparability analysis.Clinical studies, the case can be used for statistical analysis of comparatives.In the basic research, should be The pre-medication data were used for significance test between two groups. If they were not statistically different, they were not rejected from the same population (P> 0.05).