Before Consent: Cancer Patients' Deliberations about Early Phase Clinical Trials

描述(由申请人提供)：这项由一位新的研究人员提出的建议审查了晚期癌症患者关于早期临床试验的决定。基础和转化研究的进展可能预示着新的靶向疗法的到来，这些疗法将改善癌症治疗并降低死亡率，但所有这些疗法都必须在早期(EP)临床试验中进行安全性测试，才能使公众受益。招募更多的患者参加EP试验可能会加快新癌症疗法的开发，一些人认为，试验和参与是一种社会义务。但是，那些参与早期试验的人-已经用完了标准治疗选择的晚期癌症患者-是一个非常脆弱的群体，目前确保知情同意的程序并不健全。尽管生物伦理学家和社会和行为科学家寻求改善EP癌症试验中的知情同意程序，但在同意程序开始之前的一段时间里，人们对患者决策的关注较少。本研究通过三个具体目标对“事先同意”阶段提供了一个丰富的描述性和纵向视角。对于目标1，焦点小组被用来描述提供者在早期阶段招聘中的角色。在目标2中，使用有效的定量工具、定性访谈和临床参与者观察来收集关于ACC患者的EP经历和决定以及家庭照顾者和提供者的观点的数据，以收集晚期癌症队列(ACC，n=150)。目的3分析ACC患者对早期试验的认识和知识(目标3a)，哪些患者决定参加试验以及他们如何做出这一决定(目标3b)，以及知情同意程序的性质和结果(目标3c)。通过发展对同意前早期决策的丰富理解，研究结果可能对整个美国的临床医生-研究人员和早期试验计划具有相关性。这项研究可能会确定可以增加EP试验登记人数的方法，同时也可以改善患者为参与EP提供有意义的知情同意的能力。

DESCRIPTION (provided by applicant): This proposal by a new investigator examines decisions made by advanced cancer patients regarding early phase clinical trials. Advances in basic and translational research may herald the arrival of new, targeted therapies that will improve cancer treatment and reduce mortality, but all of these therapies must be tested for safety in early phase (EP) clinical trials before they can benefit the public. Recruiting more patients to EP trials may speed the development of new cancer therapies, and some have argued that trials< participation is a societal obligation. But, those who participate in early phase trials - advanced cancer patients who have run out of standard therapeutic options - are a highly vulnerable population, and current procedures to ensure informed consent are not robust. Even as bioethicists and social and behavioral scientists seek to improve the informed consent process in EP cancer trials, less attention has focused on patients< decision-making in the period before the consent process begins. This study provides a rich descriptive and longitudinal perspective of the "pre-consent" period via three specific aims. For aim 1, focus groups are used to describe providers< role in early phase recruitment. In aim 2, an Advanced Cancer Cohort (ACC, n=150) is assembled using validated quantitative instruments, qualitative interviews, and clinic participant- observation to gather data on ACC patients' EP experiences and decisions as well as the perspectives of family caregivers and providers. Aim 3 analyzes ACC patients< awareness and knowledge of early phase trials (aim 3a), which patients decide to participate in trials and how they make this decision (aim 3b), and the nature and outcome of the informed consent process (aim 3c). Through the development of rich understandings of early phase decision-making before consent, the study findings may have relevance for clinician-investigators and early phase trial programs throughout the United States. The study may identify approaches that can increase EP trial enrollment while also improving patients< ability to provide meaningful informed consent for EP participation.