目的 總結(jié)分析抗腫瘤新藥Ⅰ期臨床試驗外周血樣本采集的情況，為制定相關(guān)政策標準提供依據(jù)。方法 對中國醫(yī)學科學院北京協(xié)和醫(yī)學院腫瘤醫(yī)院2020年7月—2021年7月涉及人類遺傳資源申報的Ⅰ期臨床試驗的采血量進行橫斷面現(xiàn)況研究，比較分析采血總量、安全性采血量和研究性采血量的分布情況和影響因素。結(jié)果 納入的26項Ⅰ期臨床試驗中，采血總量中位數(shù)312 mL，范圍在148～479 mL；安全性采血量中位數(shù)212 mL，范圍在76～373 mL；研究性采血量中位數(shù)87 mL，范圍在0～193 mL；前2周期采血量占比中位數(shù)30.5%，范圍在9.4%～59.5%。大部分（88.5%）項目的采血量控制在合理的范圍內(nèi)，抗體偶聯(lián)類藥物、小分子靶向藥和首次人體試驗的采血量較多。結(jié)論 抗腫瘤新藥Ⅰ期臨床試驗的外周血樣本采集應(yīng)具有明確的科學依據(jù)并將總量控制在合理的范圍內(nèi)，同時建議遵循統(tǒng)一標準、合理設(shè)計、控制總量、充分告知、注重溝通的原則，優(yōu)化臨床試驗生物樣本管理。

Objective To summarize and analyze the collection of peripheral blood samples from phase I clinical trials of antitumor drugs, and to provide the basis for the formulation of relevant policy standards. Methods A cross-sectional survey was conducted on the amount of blood collected in Phase I clinical trials involving the declaration of human genetic resources in the Cancer Hospital of the Chinese Academy of Medical Sciences. The distribution and influencing factors of total blood collection, safety blood collection and research blood collection were compared. Results A total of 26 clinical trials were included. The median volume of total blood collection was 312 mL, ranging from 148 to 479 mL, and the median volume of safety blood collection was 212 mL, ranging from 76 to 373 mL, the median volume of research blood collection was 87 mL, ranging from 0 to 193 mL, and the median proportion of blood collected in the first two cycles was 30.5%, ranging from 9.4% to 59.5%. The total blood collection volume of most projects is controlled within a reasonable range. The antibody-drug conjugate (ADC) drugs, small molecular target drugs and the First-in-human trials have more blood samples. Conclusion The collection of peripheral blood samples in phase I clinical trials of new antitumor drugs should have a clear scientific basis and limit the total amount to a reasonable range. At the same time, it is suggested to optimize the biological sample management of clinical trials by following the principles of unified standards, reasonable design, limiting the total amount, fully informing and paying attention to communication.

R979.1

北京市研究型病房建設(shè)（BCRW202003）