Ethical Challenges in Cancer Clinical Research

描述(由申请者提供)：涉及人体受试者的研究 成人和儿童肿瘤学的组成部分，因此该领域要求 认真关注研究伦理。与此同时，癌症临床 调查可以被视为检验概念性主张的实验室 在研究伦理方面。本申请中描述的研究解决了关键 癌症相关研究的伦理挑战。项目1将审查所有 3个国家癌症合作社开展的随机临床试验 在过去的20年里，这些团体。它的主要目标是描述 在发现控制组优于实验组的随机对照试验中， 上级，或两只手臂等同。这些比例将构成基础 判断均衡性是否为癌症随机对照试验的系统性特征 是存在的。 项目2是一个概念性项目，用来考虑是否有可能证明 将受试者纳入随机对照试验的时间较晚，初步数据可能很有说服力 不是一只手臂或另一只手臂的优势。我们将研究 选择随机对照试验停止规则的关键伦理假设， 然后从经验和概念两个方面挑战这些假设 观点。 最后，在项目3中，我们将对大量的癌症患者进行关于 他们对未来使用组织样本的预期同意的态度 研究性研究。这是道德和政策中一个有争议的领域， 当前辩论的结果可能对以下方面产生相当大的影响 癌症研究。我们的发现将通过确保 癌症患者的优先事项也会被听到。 在伊齐基尔·伊曼纽尔博士、简·威克斯和罗伯特·特鲁格的指导下，这 该奖项将允许Joffe博士获得成为一名 成功的独立研究员，在临床， 经验性和概念性研究伦理。除了支持 这里描述的研究和哈佛公共卫生学院的课程 和肯尼迪政府学院，这个奖项将促进Joffe博士 将发展作为地方和国家研究伦理方面的资源 肿瘤学社区。

DESCRIPTION (provided by applicant): Studies involving human subjects are integral to adult and pediatric oncology, and the field therefore demands careful attention to research ethics. At the same time, cancer clinical investigation can be viewed as a laboratory in which to test conceptual claims in research ethics. The studies described in this application address key challenges in the ethics of cancer-related research. Project 1 will review all randomized clinical trials (RCTs) conducted by 3 national cancer cooperative groups over the past 2 decades. Its major goal is to describe the proportions of RCTs that found the control arm to be superior, the experimental arm to be superior, or the 2 arms to be equivalent. These proportions will form the basis of a judgment about whether equipoise as a systematic feature of cancer RCTs exists. Project 2 is a conceptual project to consider whether it is possible to justify enrolling subjects late in an RCT, when preliminary data may point strongly but not conclusively to the superiority of one arm or the other. We will examine the key ethical assumptions underlying the choice of stopping rules for RCTs, and then challenge those assumptions from both the empirical and conceptual points of view. Finally, in Project 3 we will survey a large number of cancer patients about their attitudes towards prospective Consent to use of tissue samples in future research studies. This is a controversial area of ethics and policy, and the outcome of the current debate is likely to have considerable repercussions for cancer research. Our findings will inform policy by ensuring that the wishes and priorities of cancer patients are heard. With the mentorship of Drs. Ezekiel Emanuel, Jane Weeks and Robert Truog, this award will permit Dr. Joffe to gain the skills and experience necessary to be a successful independent investigator at the dynamic intersection of clinical, empirical and conceptual research ethics. In addition to supporting the research described here and coursework at the Harvard School of Public Health and Kennedy School of Government, this award will foster Dr. Joffe's development as a local and national resource in research ethics for the oncology community.