目的 通過(guò)定性訪談的方法探索影響生物等效性試驗(yàn)受試者招募的可能因素，以期提高招募速度并為保證入組質(zhì)量提供參考和思路。方法 在天津中醫(yī)藥大學(xué)第一附屬醫(yī)院臨床試驗(yàn)中心2020年9月—2021年6月開(kāi)展的生物等效性試驗(yàn)受試者中，隨機(jī)選擇12名受試者作為研究對(duì)象，設(shè)計(jì)半結(jié)構(gòu)式定性訪談提綱，采用個(gè)人深度訪談形式，對(duì)受試者臨床試驗(yàn)整體認(rèn)知、積極性影響因素兩方面進(jìn)行訪談。結(jié)果 無(wú)醫(yī)學(xué)背景的受訪者對(duì)臨床試驗(yàn)認(rèn)知相對(duì)不足，角色認(rèn)同感較消極；受訪者總體對(duì)臨床試驗(yàn)的參與持積極態(tài)度，影響參與度的因素包含“補(bǔ)償費(fèi)用”“藥物安全性”“周期”“采血量”“個(gè)人時(shí)間”“行程/研究地點(diǎn)”“機(jī)構(gòu)硬件設(shè)施”和“護(hù)理質(zhì)量”等關(guān)鍵詞，其中以“補(bǔ)償費(fèi)用”和“試驗(yàn)藥物安全性”為主要影響因素。結(jié)論 科學(xué)普及臨床試驗(yàn)知識(shí)，增加受試者對(duì)臨床試驗(yàn)的認(rèn)知；豐富重視知情同意內(nèi)容，注重溝通，做好安全性風(fēng)險(xiǎn)控制；合理設(shè)定受試者補(bǔ)償費(fèi)用額度，是可能提高受試者對(duì)招募回應(yīng)度的可行方法。

Objective To explore the possible factors affecting the recruitment of subjects in bioequivalence test by qualitative interview, so as to provide reference for improving the recruitment speed and ensuring the quality of enrollment. Methods Among participants of bioequivalence trial conducted in First Teaching Hospital of Tianjin University of Traditional Chinese Medicine in September 2020-June 2021, 12 subjects were randomly selected as the research object. Semi-structured qualitative depth interview was done for exploring motivation factors. Results The interviewees without medical background had less cognition of clinical trials, and their role identity was more negative. The factors influencing the participants' participation in clinical trials included "compensation", "drug safety", "duration","blood volume", "personal schedules", "study site", "hardware facilities", "quality of care", and other keywords, and the main influencing factors were "compensation" and "safety". Conclusion It is possible to improve the response of subjects to recruitment by popularizing knowledge of clinical trial and increasing subjects' cognition, enriching the safety content of informed consent, paying attention on security risk control and setting reasonable compensation.

R969

國(guó)家科技重大專項(xiàng)（民口）重大新藥創(chuàng)制專項(xiàng)（2020ZX09201-008）