🔬 **I期临床试验的核心目标：** I期临床试验是药物研发的初步阶段，其主要目的是评估候选药物在人体内的安全性、耐受性以及药物在体内的吸收、分布、代谢和排泄（药代动力学）。与后续阶段不同，I期试验的参与者通常是健康的志愿者，而非患有目标疾病的患者，因为此时的重点是回答“这种药物是否对人体有危险的副作用？”、“它是如何被身体代谢和清除的？”以及“能否给予足够剂量以产生某种潜在益处？”等基本安全性和药代动力学问题，而非直接评估其治疗效果。

💰 **参与者的主要动机：经济报酬** 文章指出，绝大多数I期临床试验的参与者是出于经济利益的驱动。健康志愿者参与此类研究的动机几乎完全是金钱，而非对科学研究的贡献或对特定疾病的兴趣。这种经济驱动的性质是理解参与者行为和研究环境的关键因素。

⚖️ **参与者与研究者的相互戒备：** 研究参与者和临床研究人员之间普遍存在一种相互戒备和不信任的关系。这种不信任并非偶然，而是根植于参与者群体中的文化认知以及诊所和研究机构自身的激励机制。这种“文化层面的不信任”和“机构层面的激励”共同塑造了研究过程中的互动动态，使得双方往往持谨慎态度，缺乏完全的敞开和信任。

📊 **研究的局限性与个体经验的重要性：** 由于参与者与研究者之间普遍存在的戒备，以及相关研究本身的复杂性，系统性地研究临床研究参与者的行为和动机往往难以实现。因此，本文作者强调，其分享的内容主要基于个人经验以及与其他参与者交流的经历，这些第一手资料对于理解I期临床试验的实际运作和参与者体验具有重要价值。

[This is one of the finalists in the 2025 review contest, written by an ACX reader who will remain anonymous until after voting is done. I’ll be posting about one of these a week for several months. When you’ve read them all, I’ll ask you to vote for a favorite, so remember which ones you liked]

If you’ve been following this blog for long, you probably know at least a bit about pharmaceutical research. You might know a bit about the sort of subtle measures pharmaceutical companies take to influence doctors’ prescribing habits, or how it takes billions of dollars on average to bring a new medication to market, or something about the perverse incentives which determine the FDA’s standards for accepting or rejecting a new drug. You might have some idea what kinds of hoops a company has to jump through to conduct actual research which meets legal guidelines for patient safety and autonomy.

You may be less familiar though, with how the sausage is actually made. How do pharmaceutical companies actually go through the process of testing a drug on human participants?

I’m going to be focusing here on a research subject’s view of what are known as Phase I clinical trials, the stage in which prospective drugs are tested for safety and tolerability. This is where researchers aim to answer questions like “Does this drug have any dangerous side effects?” “Through what pathways is it removed from a patient’s body?” and “Can we actually give people enough of this drug that it’s useful for anything?” This comes before the stage where researchers test how good a drug is at actually treating any sort of disease, when patients who’re suffering from the target ailments are given the option receive it as an experimental treatment. In Phase I clinical trials, the participants are healthy volunteers who’re participating in research for money. There are almost no cases in which volunteer participation is driven by motivations other than money, because the attitudes between research participants and clinicians overwhelmingly tend to be characterized by mutual guarded distrust. This distrust is baked into the process, both on a cultural level among the participants, and by the clinics’ own incentives.

All of what follows is drawn from my own experiences, and experiences that other participants in clinical pharmaceutical research have shared with me, because for reasons which should become clear over the course of this review, research which systematically explores the behaviors and motives of clinical research participants is generally not feasible to conduct.

https://www.astralcodexten.com/p/your-review-participation-in-phase