University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Wake Technical Community College, Raleigh, NC, USA.
Clin Trials. 2021 Aug;18(4):477-487. doi: 10.1177/17407745211011069. Epub 2021 May 2.
BACKGROUND/AIMS: 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.
背景/目的：参与研究的经济补偿是涉及人体受试者招募的伦理关注的一个主要焦点。 Ⅰ 期试验有时被认为是健康志愿者收入丰厚的来源，这促使一些人成为“职业豚鼠”。 然而，对于这些临床试验实际支付的金额以及健康志愿者从中获得的收入却知之甚少。
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 期试验筛选和入组的详细信息。 在 3 年的时间里，参与者通过在线或电话向我们提供了他们筛选的每一项临床试验的信息（例如诊所名称、研究的治疗领域、试验的长度、在诊所过夜的次数以及研究补偿），以及他们是否符合试验纳入标准。 临床试验日记生成了有关参与者是否继续筛选和参加临床试验以及从参与中获得多少收入的数据。
131 名参与者定期完成临床试验日记或确认他们没有为任何新的临床试验进行筛选。 这些参与者在 3 年期间在 73 个研究机构共筛选了 1001 项临床试验。 总体而言，临床试验补偿中位数为 3070 美元（范围为 150-13000 美元）。 寻求新的健康志愿者试验的参与者平均每年筛选三项研究，参加一项或两项研究，每年收入约 4000 美元。 与全职或兼职工作的参与者相比，失业的参与者从临床试验中获得的收入最多，而我们由于持续追求临床试验而将其标记为“职业”参与者的那些人比偶尔筛选的人收入更高。 值得注意的是，对于所有就业群体而言，临床试验的中位数年度补偿都远低于 10000 美元，大多数职业健康志愿者每年的收入也低于 10000 美元。 收入最高的 10%的参与者的年收入中位数为 18885 美元，他们的收入在不同年份波动很大。
尽管人们普遍认为参与Ⅰ 期试验可以带来可观的收入，但在这项研究中，几乎没有人在一年内赚到超过 20000 美元，甚至很少有人赚到 10000 至 20000 美元之间。 从伦理角度来看，个别试验可能通过提供巨额款项来不当诱导入组，但根据我们的发现，对于低收入参与者来说，更大的问题可能是一种不切实际的观念，即临床试验本身可能是一种谋生的方式。
