一项单克隆抗体药物临床试验健康受试者筛选失败原因分析

Analysis of the reasons for failure of screening healthy subjects in a clinical trial of monoclonal-antibody drugs

目的探讨分析生物大分子新药临床试验过程中,健康受试者筛选失败的原因。方法分析一项单克隆抗体药物临床试验中300例筛选失败受试者的资料,对筛选失败的原因进行归纳总结,探讨其中可能的影响因素。结果与筛选失败相关的因素中非实验室检查项与实验室检查项比例基本相当,97%的受试者因为1～2项原因导致筛选失败,仅有3%的受试者因多项(3～5项)原因筛选失败。筛选失败客观原因中,生化异常占19. 13%,血清免疫球蛋白E异常占18. 03%,生命体征异常占14. 48%;主观原因导致筛选失败比例占6. 28%。结论通过科学设计试验方案,强化知情同意过程以及完善招募信息等方面的改进,有助于提高生物大分子新药临床试验健康受试者筛选成功率。

Objective To analyze the reasons for the failure of screening healthy subjects in the clinical trials of new biomacromolecular drugs.Methods The data of 300 subjects who failed to be screened in a clinical trial of monoclonal-antibody drugs were analyzed,summarized the reasons for the failure of screening,and discussed the possible influencing factors.Results The proportion of non-laboratory examination items and laboratory examination items related to screening failure was basically the same.And 97%of subjects failed screening for 1-2 reasons,and only 3%of subjects failed screening for 3-5 reasons.Among the objective reasons for the failure of screening,19.13%were biochemical abnormalities,18.03%were abnormal serum immunoglobulin E,and 14.48%were abnormal vital signs.The failure rate of screening due to subjective reasons accounted for 6.28%.Conclusion It is helpful to improve the success rate of screening healthy subjects in clinical trials of new biomacromolecular drugs through scientific design of the protocol,strengthening the informed consent process and improving recruitment information.