NCI TRANSITION CAREER DEVELOPMENT AWARD

描述：（申请人的描述）本奖项的目的是 为候选人提供75%的“受保护时间”，作为一个新的独立候选人， 研究人员，制定一项研究计划，借鉴以往的经验， 临床、转化和癌症预防/控制科学。 为董事 在大学癌症中心的临床研究，候选人是在 开发全面项目调查的独特而理想的职位 教育，行为，认知和应用伦理方面的 肿瘤临床试验 拟议的研究计划解决了提出的问题 PA-99-079，“人类研究中的伦理问题研究”和R 01 申请将提交给NIH，以回应本PA。 初步 候选人已经开展了这方面的工作。 的假设 目前用于知情决策的方法是： 肿瘤学临床试验的潜在受试者阻碍了 患者理解研究的基本要素， 这些试验的有效招募、保留和依从性。 的 该项目的具体目标是：（1）调查具体的 对潜在受试者临床测量理解的干预 试验; 2）确定肿瘤患者不同策略的结果 招聘、保留和合规; 3）比较风险：效益评估 潜在受试者在肿瘤学与非肿瘤学环境中使用的过程;以及 4)研究计划使用和今后可能使用收集到的 组织或细胞作为关于治疗决策的实验室相关物 审判 该项目的第一年将致力于完成 分析和公布初步数据，并提交R 01 在第二年年底前申请。 到第三年结束时， 计划，候选人应该处于有利地位，以实施一个计划， 独立研究与校外资金支持。 这些调查结果 调查将有助于显著改善结果， 临床试验以及累积足够数量受试者的能力 回答癌症预防，治疗和相关的关键问题 科学

DESCRIPTION: (Applicant's Description) The purpose of this award is to provide 75 percent "protected time" for the Candidate, as a newly-independent investigator, to develop a research program drawing on previous experiences in clinical, translational, and cancer prevention/control sciences. As Director of Clinical Research in a University-based Cancer Center, the Candidate is in a unique and ideal position to develop a comprehensive program investigating the educational, behavioral, cognitive, and applied ethical aspects of oncology clinical trials. The proposed Research Plan addresses issues raised in PA-99-079, "Research on Ethical Issues in Human Studies", and an R01 application will be submitted to the NIH in response to this PA. Preliminary work in this area has already been conducted by the Candidate. The hypothesis of the proposal is: The current approach used for informed decision-making by potential subjects for oncology clinical trials impedes the ability of patients to comprehend the essential elements of research studies, and impacts effective recruitment, retention, and compliance for these trials. The specific aims of the project are to: 1) investigate the effects of specific interventions on potential subjects' measured comprehension of clinical trials; 2) determine the outcomes of different strategies for oncology patient recruitment, retention, and compliance; 3) compare the risk:benefit appraisal process used by potential subjects in oncology vs. non-oncology settings; and 4) study the consequences of planned and possible future use of collected tissues or cells as laboratory correlates on decision-making about therapeutic trials. The initial year of the project will be directed toward completion of analysis and publication of preliminary data, with submission of the R01 application by the end of Year 2. By the conclusion of the third year of the program, the Candidate should be well-positioned to implement a program of independent research with extramural funding support. Findings from these investigations would contribute toward significantly improving outcomes in clinical trials as well as the ability to accrue adequate numbers of subjects to answer critical questions in cancer prevention, therapy, and correlative science.