乳腺癌药物临床试验受试者脱落的原因分析及对策

Cause analysis and countermeasures of patient's expulsion rate in breast cancer drug clinical trials

目的分析乳腺癌药物临床试验受试者脱落的主要因素,根据相关影响因素,探讨如何降低乳腺癌药物临床试验受试者脱落率。方法收集2012年6月至2015年1月于本院参加乳腺癌药物临床试验的405例受试者资料,对其脱落率进行调查分析。结果 405例受试者中,共有85例受试者脱落,以受试者要求退出及不良事件为脱落的主要原因。影响受试者脱落的主要因素有受试者依从性以及受试者心理特征等。依从性差的受试者的脱落率为70.9%(44/62),明显高于依从性好的受试者的11.9%(41/343),差异具有统计学意义(P<0.01)。有明显心理特征的受试者的脱落率为57.1%(20/35),明显高于无明显心理特征的受试者的17.6%(65/370),差异有统计学意义(P<0.01)。国内/国际药物、用药方式、返院频次、临床试验分期等,在依从者和脱落者中的分布均无显著差异。结论为减少乳腺癌药物临床试验受试者脱落率,可加强受试者管理、加强研究者管理和及时处理不良事件。

Objective To analyze the major causes of breast cancer drug clinical trials＇ patients expulsion and find new meth- ods to reduce the expulsion rate. Methods The report collected the messages of patients who participated the breast cancer drug trial in my hospital from June 2012 to January 2015 and analyzed the patient＇s expulsion reasons. Results Among the 405 subjects, the ex- pulsion of 85 participants were recorded. The major causes of patient expulsion were patients＇ compliance and psychological features. The patients who had less compliance had a higher expulsion rate than those who had better compliance [ 70.9% （44/62） vs. 11.9% （41/343） ] and the difference was significant（ P〈0. 01 ）. The expulsion rate was more significant in the patients who had obvious psy- chological features [ 57. 1% （20/35） vs. 17. 6% （65/370） ] with significant difference （P〈0. 01 ）. The distributions of drug types, med- ication, the courtyard frequency and clinical trial stage between the compliance and fall off patients had no significant difference. Con- elusion To reduce the patient expulsion rate of breast cancer drug trials, we can focus on the management of patients and physicians and solve the adverse events in time.