編盲是藥物臨床試驗的重要環(huán)節(jié)，可直接影響到臨床試驗盲法實施的質量。目前編盲工作存在的問題有參與各方責任明確，但監(jiān)管尚有不及；參與人員的實際工作經驗不足，缺乏系統(tǒng)培訓；安慰劑制備質量參差不齊，存在較大破盲風險；編盲現(xiàn)場操作不規(guī)范，對編盲現(xiàn)場工作流程及細節(jié)不能充分把握，嚴重影響工作的質量和效率?；诰幟すぷ髦写嬖诘膶嶋H問題，提出具體建議：明確監(jiān)管方，提高監(jiān)管力度；強化責任意識，重視責任歸屬；明確人員分工，加強規(guī)范培訓；適應工作需求，不斷完善標準操作規(guī)程（SOP）。以期與同行探討，共同推動編盲工作的標準化與規(guī)范化，從源頭為臨床試驗盲法的開展奠定堅實的基礎。

Blinding is an important segment of drug clinical trials, which can directly affect the quality of clinical trial. The current problems of blinding are as follows: Responsibilities clearly of all participants but lack of supervision; due to lack of training, there is a significant difference in the abilities and experiences of the participants. There is a high risk of blinding failure cause of the quality of placebo preparation varies. The on-site operation of blinding is not standardized, which seriously affects the quality and efficiency of work. Based on the above issues, suggestions include: Clarifying regulatory authorities and increasing regulatory efforts, strengthening the sense of responsibility and attaching importance to the attribution of responsibility, clarifing personnel division of labor and strengthening standardized training, improving standard operating procedures (SOP) continuously in order to adapt working needs. The standardization process of the blinding requires peer communication. Supervision and responsibility are important guarantees for the high-quality blinding implementation in clinical trials.

R951

重大新藥創(chuàng)制科技重大專項（2017ZX09304019）；北京中醫(yī)藥大學東直門醫(yī)院 2022 科技創(chuàng)新專項（DZMKJCX-2022-013）