Phase I trial compensation: How much do healthy volunteers actually earn from clinical trial enrollment?
Phase I trial compensation: How much do healthy volunteers actually earn from clinical trial enrollment?
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DOI：
10.1177/17407745211011069
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发表时间：
2021-08
期刊：
影响因子：
--
通讯作者：
Walker RL
中科院分区：
文献类型：
--
作者：
Fisher JA;McManus L;Kalbaugh JM;Walker RL
对参与研究的经济补偿是关于人类受试者招募的伦理关注的主要焦点。I期试验有时被认为是健康志愿者的一个有利可图的收入来源，鼓励一些人成为“专业豚鼠”。然而，很少有人知道这些临床试验实际上支付了多少钱，以及健康志愿者从中获得了多少收入。作为一项针对健康志愿者的混合方法纵向研究的一部分，我们要求参与者完成临床试验日记或调查，以获取有关I期试验筛选和招募的详细信息。在3年的时间里，参与者在线或通过电话提供有关他们筛选的每个临床试验的信息（例如诊所名称，研究的治疗领域，试验的长度，在诊所度过的夜晚数量和研究补偿），以及他们是否有资格参加试验。临床试验日记生成的数据包括参与者是否继续筛选和参加临床试验，以及他们从参与中获得了多少钱。131名参与者定期完成临床试验日记或确认他们没有筛选任何新的临床试验。这些参与者在3年的时间里在73个研究机构共筛选了1001项临床试验。总体而言，中位临床试验补偿为3070美元（范围= 150 - 13，000美元）。寻求新的健康志愿者试验的参与者倾向于每年筛选三项研究，参加一两项研究，每年收入约为4000美元。与那些有全职或兼职工作的人相比，失业的参与者从临床试验中获得的收入最多，而那些我们标记为“职业”参与者的人，因为他们坚持不懈地追求临床试验，比偶尔筛查的人赚得更多。值得注意的是，所有就业群体的年度试验报酬中位数远低于10，000美元，大多数职业健康志愿者的年收入也低于10，000美元。收入最高的10%参与者从临床试验中获得的年收入中位数为18，885美元，这些人的收入每年都有很大的波动。尽管人们认为第一阶段的入组可以产生可观的收入，但在这项研究中，任何人在一年内赚超过20，000美元的情况都是极其罕见的，甚至在10，000美元到20，000美元之间也是不寻常的。从伦理学的角度来看，个别试验可能会通过提供大量资金来过度诱导招募，但鉴于我们的研究结果，低收入参与者的更大问题可能是不切实际的看法，即临床试验本身可能是一种谋生方式。
Financial compensation for research participation is a major focus of ethical concern regarding human subject recruitment. Phase I trials are sometimes considered to be a lucrative source of income for healthy volunteers, encouraging some people to become “professional guinea pigs.” Yet, little is known about how much these clinical trials actually pay and how much healthy volunteers earn from them. As part of a mixed-methods, longitudinal study of healthy volunteers, we required participants to complete clinical trial diaries, or surveys that captured detailed information about screening and enrollment in Phase I trials. Over a 3-year period, participants provided information online or via telephone about each clinical trial for which they screened (e.g. the clinic name, the study’s therapeutic area, the length of the trial, the number of nights spent in the clinic, and the study compensation), and whether they qualified for trial inclusion. Clinical trial diaries generated data about whether participants continued to screen for and enroll in clinical trials and how much money they earned from their participation. 131 participants routinely completed clinical trial diaries or confirmed that they had not screened for any new clinical trials. Together, these participants screened for 1001 clinical trials at 73 research facilities during a 3-year period. Overall, the median clinical trial compensation was US$3070 (range = US$150–US$13,000). Participants seeking new healthy volunteer trials tended to screen for three studies per year, participate in one or two studies, and earn roughly US$4000 annually. Participants who were unemployed earned the most income from clinical trials compared to those with full-time or part-time jobs, and those individuals whom we label “occupational” participants because of their persistent pursuit of clinical trials earned more than people who screened occasionally. Notably, the median annual trial compensation was well below US$10,000 for all employment groups, and most occupational healthy volunteers also earned less than US$10,000 each year. The 10% of participants who earned the most had a median annual income of US$18,885 from clinical trials, and there was significant volatility in these individuals’ earnings from year to year. Despite the perception that Phase I enrollment can generate significant earnings, it was exceedingly rare for anyone in this study to make more than US$20,000 in a single year, and unusual to earn even between US$10,000 and US$20,000. From an ethics perspective, individual trials might appear to unduly induce enrollment by offering significant sums of money, but given our findings, the larger problem for low-income participants may be the unrealistic perception that clinical trials alone could be a way of earning a living.
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