Overcoming Barriers to Early Phase Clinical Trials

描述（由申请人提供） 患者增加是临床研究的一个长期障碍。尽管对所有阶段的临床试验给予了广泛的重视，但研究估计，只有不到5%的新癌症患者参加了所有阶段和类型的临床试验。临床试验入组的障碍是多方面的，包括医生、患者和系统组件。类似的障碍似乎影响到整个国家，特别是所有NCI指定的癌症中心。这在早期临床试验中尤其如此，其中治疗效果不如后期研究确定。 该申请提出探索早期临床试验的四个主要障碍-缺乏保险覆盖，沟通问题，医生时间限制和信任/理解问题-利用简单和可重复的模型，如果有效，可以很容易地在其他癌症中心或其他疾病领域中翻译。 这项建议的具体目标是： 1)为了确定在早期临床试验中接受治疗的患者与替代的市售化疗药物或最佳支持治疗的患者的治疗成本是否存在显著差异，并评估使用所得数据克服保险覆盖范围障碍以获得收益的有效性，2）为了评估新的沟通模式/技术可以在多大程度上支持早期临床试验的收益，3）评估新的人员配备模式克服医生和工作人员时间限制障碍的能力，并增加早期临床试验的应计费用，以及4）测试辅导干预是否在少数患者中产生信任和沟通，从而提高早期临床试验的应计费用。

DESCRIPTION (provided by applicant) Patient accrual is a longstanding obstacle to clinical research. Despite widespread importance placed on clinical trials of all phases, research estimates that less than 5% of new cancer patients are enrolled on clinical trials of all phases and types. The barriers to clinical trials enrollment are multi-faceted, with physician, patient, and system components. Similar barriers seem to affect the entire country and, specifically, all NCI-designated Cancer Centers. This is particularly the case in early phase clinical trials, where therapeutic effectiveness is less definitive than in later phase studies. This application proposes to explore four major barriers to early phase clinical trials - lack of insurance coverage, communication issues, physician time constraints, and trust/understanding issues - utilizing simple and reproducible models that, if effective, could be easily translated in other Cancer Centers, or in other disease areas. The specific aims of this proposal are: 1) To determine if there is a significant difference in treatment cost for patients treated on early phase clinical trials versus an alternative commercially available chemotherapeutic agent(s) or best supportive care, and to assess the effectiveness of using the resulting data in overcoming insurance coverage barriers to accrual, 2) To evaluate the extent to which new communication models/technologies can bolster early phase clinical trials accrual, 3) To assess the ability of a new staffing model to overcome the barrier of physician and staff time constraints and to increase accrual to early phase clinical trials, and 4) To test whether a coaching intervention engenders trust and communication in minority patients thereby enhancing accrual to early phase clinical trials.