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

描述（由申请人提供）：新研究者的这项提案审查了晚期癌症患者就早期临床试验做出的决定。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，然后才能使公众受益。招募更多的患者参加EP试验可能会加速新癌症疗法的开发，有些人认为试验参与是一种社会义务。但是，那些参加早期试验的人--已经用尽标准治疗选择的晚期癌症患者--是一个非常脆弱的人群，目前确保知情同意的程序并不健全。 即使生物伦理学家和社会及行为科学家寻求改善EP癌症试验中的知情同意过程，但在知情同意过程开始前的一段时间内，对患者决策的关注较少。本研究提供了一个丰富的描述性和纵向的“同意前”期间通过三个具体的目标。对于目标1，焦点小组被用来描述提供者在早期招募中的作用。在目标2中，使用经验证的定量工具、定性访谈和临床参与者观察来组装晚期癌症队列（ACC，n=150），以收集关于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。目的3分析ACC患者对早期试验的认识和了解（目的3a），哪些患者决定参加试验以及他们如何做出这一决定（目的3b），以及知情同意过程的性质和结果（目的3c）。 通过对知情同意前早期决策的丰富理解，研究结果可能与美国各地的临床研究人员和早期试验项目相关。该研究可以确定可以增加EP试验入组同时还提高患者提供EP参与的有意义的知情同意的能力的方法。 公共卫生相关性：开发新的癌症疗法是国家的优先事项，但这些疗法首次测试的晚期癌症患者非常脆弱。这项研究探讨了晚期癌症患者如何决定参加一项新疗法的试验。该研究旨在收集信息，以改善开发癌症疗法的系统，而不会使脆弱的癌症患者处于不适当的风险之中。

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. PUBLIC HEALTH RELEVANCE: Developing new cancer therapies is a national priority, but the advanced cancer patients in whom these therapies are first tested are highly vulnerable. This study examines how advanced cancer patients make decisions about participating in a trial of a new therapy. The study aims to gather information that can improve the system for developing cancer therapies without putting vulnerable cancer patients at undue risk.