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

描述（由申请人提供）：该提案由一位新的研究者提出，研究晚期癌症患者对早期临床试验的决定。基础研究和转化研究的进步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临床试验（EP）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试验可能会加速新的癌症疗法的发展，一些人认为参与试验是一种社会义务。但是，那些参与早期试验的人——已经用尽标准治疗方案的晚期癌症患者——是一个非常脆弱的人群，而且目前确保知情同意的程序并不健全。尽管生物伦理学家、社会和行为科学家试图改善脑癌试验中的知情同意程序，但对患者在知情同意程序开始之前的决策过程的关注却很少。本研究通过三个具体目标，为“预同意”时期提供了丰富的描述性和纵向视角。对于目标1，焦点小组用于描述提供者在早期招聘中的作用。在目的2中，采用经过验证的定量工具、定性访谈和临床参与者观察，收集了一个晚期癌症队列（ACC, n=150）的数据，以收集ACC患者的EP经历和决策，以及家庭照顾者和提供者的观点。目标3分析ACC患者对早期试验（目标3a）的认知和知识，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），以及知情同意过程的性质和结果（目标3c）。通过对同意前早期决策的丰富理解的发展，研究结果可能对临床研究人员和整个美国的早期试验项目具有相关性。该研究可能会确定可以增加EP试验入组的方法，同时也可以提高患者为EP参与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. 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.