药物临床试验健康受试者筛选及给药后安全性评价吉林共识(2023版)

Jilin consensus on screening healthy subjects and safety evaluation after drug administration in clinical trials

受试者筛选和安全性评价均是药物临床试验质量保证的重要环节,是否能筛选到足够符合要求的受试者并对受试者进行客观、科学的安全性评价与分析是关系到临床试验能否顺利进行,并得出科学结论的关键影响因素。目前,两者均在实际工作中面临较大挑战。一是在纳入健康受试者的临床试验中,健康受试者并无明确入排标准界定,各家判断不一。二是受试者的安全性评价及分析存在尺度不一、主观性大等问题,缺乏指导性的规则和方法。为规范和帮助药物临床试验中对受试者筛选及给药后安全性评价与分析工作,吉林省药理学会临床药理学专业委员会撰写了本共识,旨在更好地指导纳入受试者和评价分析药物对受试者的安全性。

Subject screening and safety evaluation are pivotal components of ensuring the quality of drug clinical trials.It is imperative to select eligible healthy subjects and assess their safety in an objective and scientific manner,thereby guaranteeing the progress of clinical trials and obtaining valid scientific conclusion.However,both aspects are currently confronted with significant challenges in practice.Firstly,the inclusion criteria for healthy subjects are yet to be universally established,Results ing in varying judgments across different institutions.Secondly,the evaluation and analysis of subject safety often suffer from inconsistent scales and subjective assessments.Furthermore,there is a dearth of guiding rules and method,hampering the standardization of such processes.To promote uniformity and facilitate subject selection,safety evaluation and analysis in drug clinical trials,the Clinical Pharmacology Committee of Jilin Pharmacology Society has compiled this consensus document,in order to provide comprehensive guidelines for such problems.Subject screening and safety evaluation are key to assuring the quality of drug clinical trials.The selection of eligible healthy subjects and the objective scientific assessment of their safety are crucial components of ensuring the quality of drug clinical trials.The progress of clinical trials and the validity of scientific conclusions depend on these two aspects.However,current practices in both areas face significant challenges.Firstly,the criteria for healthy subject inclusion have yet to be universally established,leading to variable judgments across different institutions.Secondly,the evaluation and analysis of subject safety often suffer from inconsistent scales and subjective assessments.Additionally,a lack of guiding rules and methods hinders the standardization of these processes.To promote uniformity and facilitate subject selection,safety evaluation,and analysis in drug clinical trials,the Clinical Pharmacology Committee of Jilin Pharmacology Society has compiled this consensus document to provide comprehensive guidelines for these problems.