临床试验方案与知情同意书中生物样本检测后处理情况分析

Analysis and Consideration of Processing Biological Samples After Testing in Clinical Trial Protocol and Informed Consent Form

目的了解药物临床试验方案和知情同意书中生物样本检测后的处理情况,规范生物样本处理表述,确保药物临床试验的规范性和保障受试者的权益。方法搜集某医院药物临床试验机构2017年6月—2021年4月立项的药物临床试验项目,对项目的申办者、专业类型、试验分期、试验方案和知情同意书中涉及的生物样本检测后的处理表述及表述位置进行整理汇总分析。结果共计收集64个临床试验项目,其中外资(包括合资企业)项目占59.4%;内资、外资企业对检测后生物样本保存、销毁表述均差异无统计学意义(P<0.05),未提及保存、销毁生物样本的均超过50%;试验方案、知情同意书中生物样本在本院实验室检测后处理,未提及的分别占98.4%,95.3%;生物样本处理在“生物样本管理”项下表述的,试验方案和知情同意分别占73.7%,56.2%。结论试验方案、知情同意书中对于生物样本检测后处理的表述存在不足;应设立专栏,明确表述剩余生物样本的保存、销毁等最终处理方式;医院药物临床试验机构、伦理委员会等监管部门应加强对生物样本处理表述的风险把控,严格审核。

Objective To probe into processing biological samples after testing in drug clinical trial protocols and informed consent form(ICF),and to standardize the description of biological samples processing,in order to ensure the standardization of drug clinical trials and protect the rights and interests of subjects.Methods The drug clinical trial projects approved by a hospital drug clinical trial institution from June 2017 to April 2021 were collected.The sponsors,specialty,trial stages,trial plans,processing expression and description position of biological samples involved in clinical trial protocols and ICF after testing were collated and summarized.Results A total of 64 clinical trial projects were collected,of which foreign-funded(including joint ventures)projects accounted for 59.4%.Domestic and foreign-funded enterprises had no significant difference in the description of preservation and destruction of biological samples after testing(P>0.05),and more than 50% of the biological samples were not mentioned for preservation and destruction.In the study protocols and ICF,98.4% and 95.3% of biological samples processing were not mentioned in local hospital laboratory after testing,respectively.In comparison,73.7% and 56.2% of the biological samples processing were described in the item of"management of biological samples"in the study protocol and ICF,respectively.Conclusion There are limitations in the description of the part for post-testing biological samples in the clinical trial protocols and ICF.A column should be set up to clearly state the final processing methods,such as preserving and destroying the remaining biological samples after testing.The drug clinical trial institutions,ethics committees,and other regulatory authorities of hospitals should strengthen the risk control of the description of biological samples processing and strictly review them.