Wendler David, Krohmal Benjamin, Emanuel Ezekiel J, Grady Christine
Department of Bioethics, National Institutes of Health, Bldg 10, Room 1C118, Bethesda, MD 20892, USA.
Arch Intern Med. 2008 Jun 23;168(12):1294-9. doi: 10.1001/archinte.168.12.1294.
Clinical research exposes patient participants to unproved methods and research procedures in order to gather generalizable knowledge to benefit others. While some commentators argue that this process inappropriately exploits patient participants, there are few data available to evaluate this claim.
Human immunodeficiency virus (HIV)-infected individuals from Argentina, Brazil, and Thailand who had been participating in the Evaluation of Subcutaneous Proleukin (Interleukin-2) in a Randomized International Trial (ESPRIT) study for at least 6 months were invited to complete a self-administered survey on their experience and were asked why they continued to participate. The ESPRIT study is a phase 3, multinational, randomized trial comparing antiretroviral therapy plus interleukin 2 (IL-2) with antiretroviral therapy alone in individuals with HIV disease.
From a list of 12 possible reasons regarding why patient participants continue to participate, 8 options were selected as "very important" by 75% or more of 582 respondents, including the possibility of benefiting personally and the potential to help others. When asked to indicate the most important reason from this list, respondents in the IL-2 arm (n = 292) selected (1) increasing their CD4 lymphocyte count (26%); (2) finding better treatments for patients with HIV in their home country (22%); and (3) getting IL-2 (12%). Respondents in the no-IL-2 arm (n = 290) selected (1) finding better treatments for patients with HIV in their home country (32%); (2) finding better treatments for HIV-infected patients in other countries (12%); and (3) increasing their CD4 lymphocyte count (11%). Also, 90% of the respondents indicated that participation in ESPRIT involved making a "major" or "moderate" contribution to society, and 84% felt "very" or "somewhat" proud to be making this contribution.
Most respondents continue to participate in the ESPRIT study in hopes of benefiting personally. The majority also recognized that by participating in ESPRIT they were contributing to helping others; they experienced pride regarding this contribution and considered it an important reason to continue to participate. These results indicate that it is possible for patient participants, even those seeking treatment for a life-threatening illness, to recognize and embrace the goals of the research in which they participate. Future studies will be needed to determine to what extent these findings generalize to other studies and other countries and what steps can help patient participants recognize and embrace the goals of clinical research.
临床研究让患者参与者接触未经证实的方法和研究程序，以便收集可推广的知识，使他人受益。虽然一些评论家认为这一过程不适当地利用了患者参与者，但几乎没有数据可用于评估这一说法。
邀请来自阿根廷、巴西和泰国的感染人类免疫缺陷病毒（HIV）且参与皮下注射普罗白介素（白细胞介素-2）随机国际试验（ESPRIT）研究至少6个月的个体，完成一份关于其经历的自填式调查问卷，并询问他们继续参与的原因。ESPRIT研究是一项3期、多国、随机试验，比较抗逆转录病毒疗法加白细胞介素-2（IL-2）与单纯抗逆转录病毒疗法在HIV感染者中的疗效。
在关于患者参与者继续参与的12个可能原因列表中，582名受访者中有75%或更多选择了8个选项为“非常重要”，包括个人受益的可能性以及帮助他人的潜力。当被要求指出此列表中最重要的原因时，接受IL-2治疗组（n = 292）的受访者选择：（1）增加其CD4淋巴细胞计数（26%）；（2）为其本国的HIV患者找到更好的治疗方法（22%）；（3）获得IL-2（12%）。未接受IL-2治疗组（n = 290）的受访者选择：（1）为其本国的HIV患者找到更好的治疗方法（32%）；（2）为其他国家的HIV感染者找到更好的治疗方法（12%）；（3）增加其CD4淋巴细胞计数（11%）。此外，90%的受访者表示参与ESPRIT对社会做出了“重大”或“适度”贡献，84%的人对做出这一贡献感到“非常”或“有点”自豪。
大多数受访者继续参与ESPRIT研究是希望个人受益。大多数人也认识到通过参与ESPRIT他们在为帮助他人做出贡献；他们为这一贡献感到自豪，并将其视为继续参与的一个重要原因。这些结果表明，即使是那些寻求治疗危及生命疾病的患者参与者，也有可能认识并接受他们所参与研究的目标。未来需要进行研究，以确定这些发现能在多大程度上推广到其他研究和其他国家，以及哪些措施可以帮助患者参与者认识并接受临床研究的目标。
