Ethical Challenges in Cancer Clinical Research

描述（由申请人提供）：涉及人类受试者的研究 是成人和儿童肿瘤学的组成部分，因此该领域需要 认真对待研究伦理。与此同时，癌症临床 调查可以被看作是一个实验室，在其中测试概念主张 研究伦理学本申请中描述的研究解决了关键问题， 癌症相关研究的伦理挑战。项目1将审查所有 由3个国家癌症合作组织进行的随机临床试验（RCT） 在过去的20年里，它的主要目标是描述 的RCT发现对照组上级实验组， 上级，或2个臂等同。这些比例将构成基础 判断平衡是否是癌症RCT的系统特征 存在. 项目2是一个概念性项目，考虑是否有可能证明 在RCT中招募受试者的时间较晚，此时初步数据可能强烈指出， 不是决定性的一个或另一个武器的优势。我们将研究 RCT停止规则选择背后的关键伦理假设， 然后从经验和概念上挑战这些假设， 观点。 最后，在项目3中，我们将调查大量癌症患者， 他们对未来使用组织样本的预期同意书的态度 调查研究。这是一个有争议的道德和政策领域， 目前辩论的结果可能会产生相当大的影响， 癌症研究。我们的研究结果将通过确保人们的愿望 和癌症患者的优先权。 在Ezekiel Emanuel，Jane Weeks和Robert Truog博士的指导下， 奖励将允许Joffe博士获得必要的技能和经验， 成功的独立研究者在临床， 经验和概念研究伦理。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博士的 发展作为地方和国家研究伦理资源， 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.