单克隆抗体药物临床试验阶段风险评估研究

目的准确识别单克隆抗体药物临床试验风险,并对其进行风险评估。方法通过文献研究法,识别单克隆抗体药物临床试验阶段的风险。采用德尔菲法,对50位从事单克隆抗体药物临床试验的专家及研究人员进行问卷调查,对识别出的风险指标进行赞同程度评价,获取风险指标赞同程度分值、风险指标重要性分值、风险发生概率值和风险影响程度值。利用百分权重法计算风险指标权重,风险矩阵法计算风险指标风险值,并确定风险指标的风险等级。结果共识别出单克隆抗体药物临床试验5个风险因素和54个风险指标。5个高风险指标包括研究人员的选取及确定不够科学风险等级量化(RR)值为3.23]、受试者依从性不足(RR值为4.13)、试验问题解决方案的制定缺乏科学有效性(RR值为3.16)、试验数据处理人员专业水平不足(RR值为3.37)和试验数据处理及分析方法的确定不够科学(RR值为3.06)。单克隆抗体药物临床试验的总体RR值为2.52。结论单克隆抗体药物临床试验研究阶段具有较高风险,可通过科学选取研究者、全面提高受试者依从性、科学选择试验数据处理及分析方法等措施来减轻、降低风险。

Research on clinical trial risk assessment of monoclonal antibody drugs

AIM To evaluate the risk of monoclonal antibody drugs clinical trial based on accurate identification of risk sources.METHODS The risk of monoclonal antibody drugs clinical trial was identified through the literature research.The questionnaire survey was conducted among fifty experts and researchers engaged in clinical trials of monoclonal antibody drugs using the Delphi method,to assess the degree of approval of the identified risk indicators.The approval score of risk indicators,risk indicator importance score,risk occurrence probability value and risk impact degree value were obtained.The risk index weight was calculated by the percentage weight method,the risk value was calculated by the risk matrix method,and the risk grade of the risk index was determined.RESULTS A total of five risk factors and fifty-four risk indicators were identified for monoclonal antibody drugs clinical trial.The five high risk indicators include the selection and determination of the researchers were not scientific(quantitative level of risk(RR)value=3.23),insufficient subject compliance(RR=4.13),the formulation of test problem solution lacks scientific validity(RR=3.16),insufficient professional level of test data processing personnel(RR=3.37),and the determination of data processing and analysis method was not scientific enough(RR=3.06).The overall RR value of monoclonal antibody drugs clinical trial was 2.52.CONCLUSION The monoclonal antibody drugs clinical trial has a high risk.Clinical trial risk can be reduced by scientific selection of researchers,comprehensive improvement of subjects’compliance,and scientific selection of test data processing and analysis methods.