Promises Of Benefit Phase I Oncology Informed Consent

本方案将分析I期肿瘤学试验的知情同意书，以评估传达性质、风险和潜在获益的方式。第一阶段的同意书正在从所有的国家癌症研究所指定的综合癌症中心和主要的制药公司进行第一阶段的肿瘤试验。已通过电话与各机构联系，并正在发送同意书。数据收集才刚刚开始。 I期肿瘤临床试验在伦理上是有争议的，因为它们通常涉及绝症患者-受试者，几乎没有直接获益的前景。采访I期癌症受试者的研究表明，他们中的许多人希望从这些试验中受益。为了评估研究目的的描述和直接受益的承诺是如何传达给受试者的，我们汇编了80%的NCI指定癌症中心和10大癌症药物制造商中的6家的所有1999年I期肿瘤学同意书。使用评分工具，我们评估了知情同意书中的5个领域：1）试验的描述性特征，2）研究目的和程序，3）获益承诺，4）风险和5）替代方案。我们已完成知情同意书的评分，并正在对数据进行统计分析。初步结果表明，没有同意书承诺直接受益于受试者。许多表格（87%）将获益的前景定性为不确定，几乎所有表格都全面讨论了风险，包括提及死亡（70%）。最后，几乎所有的表格（90%）都指出试验的目的是测试安全性。

This protocol will analyze consent forms for Phase I oncology trials to assess the manner in which the nature, risks, and potential benefits are communicated. Phase I consent forms are being sought from all of the NCI-designated comprehensive cancer centers and from major pharmaceutical companies that conduct Phase I oncology trials. Institutions have been contacted by phone and are sending consent forms. Data gathering is just beginning. Phase I oncology clinical trials are ethically controversial because they typically involve terminally ill patient-subjects and offer almost no prospect of direct benefit. Studies interviewing Phase I cancer subjects show that many of them expect to benefit from these trials. To evaluate how the description of research purpose and the promise of direct benefit is communicated to subjects, we compiled all 1999 Phase I oncology consent froms from 80% of the NCI designated cancer centers and from 6 of the top 10 cancer pharmaceutical manufacturers. With a scoring instrument, we evaluated 5 domains in the consent forms: 1) descriptive properties of the trial, 2) the research purpose and procedures, 3) the promise of benefit, 4) risks and 5) alternatives. We have completed the scoring of the consent forms and are performing a statistical analysis on the data. Preliminary results indicate that no consent forms promised direct benefits to subjects. Many forms (87%) qualified the prospect of benefit as uncertain, and almost all forms discuss risk comprehensively, including a mention of death (70%). Finally, nearly all forms (90%) state that the purpose of the trial is to test safety.