NCI TRANSITION CAREER DEVELOPMENT AWARD

描述：(申请人描述)本奖项的目的是 为候选人提供75%的“保护时间”，作为一名新的独立候选人 调查员，根据过去在以下方面的经验制定研究计划 临床、转化和癌症预防/控制科学。担任董事 在大学癌症中心的临床研究，候选人是在 一个独特而理想的位置，可以开发一个全面的调查项目 的教育、行为、认知和应用伦理方面 肿瘤学临床试验。拟议的研究计划解决了提出的问题 见PA-99-079《人学中的伦理问题研究》，以及R01 申请将提交给国家卫生研究院，以回应这一PA。初步 候选人已经在这一领域开展了工作。假说 该提案的要点是：目前用于知情决策的方法是 肿瘤学临床试验的潜在对象阻碍了 让患者理解研究研究的基本要素和影响 这些试验的有效招募、保留和合规。这个 该项目的具体目标是：1)调查具体的影响 对潜在受试者对临床的测量理解的干预 试验；2)确定肿瘤患者不同治疗方案的结果 招聘、留住和合规；3)比较风险：利益评估 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)研究计划使用和未来可能使用收集的 作为实验室的组织或细胞与治疗决策相关 审判。该项目最初一年的目标是完成 分析和公布初步数据，并提交R01 在第二年年底前提出申请。在第三年结束时 计划，候选人应该能够很好地实施以下计划 在外部资金支持下的独立研究。来自这些的发现 调查将有助于显著改善#年的结果 临床试验以及获得足够数量受试者的能力 回答癌症预防、治疗及相关的关键问题 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.