Cancer Center Model For Early Phase Clinical Trials

描述(由申请人提供) 这项提议是开发一个社区(网络)模式，以指导和加强患者在早期临床试验中的参与。在我们的模型中，学术癌症中心仍然是这些研究的焦点，这些研究将在选定的社区站点提供。为了实现这一目标，需要清楚地阐明和克服一些障碍。由于目前绝大多数早期临床试验是在学术医学中心在学术教师的指导下进行的，因此需要探讨教师对将他们的试验扩展到社区现场的态度和担忧，并克服障碍。对于我们的临床教员，即选择参与早期临床试验的社区肿瘤学家/血液学家来说，这将是一项新的努力。尽管有合作小组和II/III期药物试验的经验，这些医生和他们的工作人员还没有参与早期临床试验。他们对参与这些试验的态度和关注将需要定义，并可能包括对教师与临床教师的互动、他们自己缺乏时间、培训和资源的看法。此外，将调查社区环境中存在的患者障碍，这些障碍到目前为止阻碍了更广泛地参与早期临床试验。根据我们到目前为止的评估，社区肿瘤学家认为，患者增加参与的障碍包括年龄、合并症、对临床试验过程的了解不足，以及离开社区前往学术中心的恐惧和费用。将制定程序来衡量态度和态度的变化，发展必要的基础设施，以便在学术中心和社区现场之间提供更紧密的联系，提供必要的现场资源，以安全和完全地进行这些试验，并在社区地点内制定外联计划，以提高对早期临床试验的认识、理解和可用性。

DESCRIPTION (provided by applicant) This proposal is to develop a community (network) model for conducting and enhancing patient participation in early phase clinical trials. In our model, the academic cancer center remains the focal point for these studies, which will be made available at selected community sites. To accomplish this goal, a number of barriers will need to be clearly elucidated and overcome. Since the vast majority of early phase clinical trials are currently conducted at academic medical centers under the direction of academic faculty, faculty attitudes and concerns about extending their trials to community sites will need to be explored and barriers overcome. For our clinical faculty, i.e. community-based oncologists/hematologists, who choose to participate in early phase clinical trials, this will be a new effort. Despite having experience in cooperative group and phase II/III pharmaceutical trials, these physicians and their staffs have not participated in early phase clinical trials. Their attitudes and concerns about participating in these trials will need to be defined and are likely to include perceptions about faculty-clinical faculty interactions, their own lack of time, training, and resources. In addition, patient barriers that exist in the community setting that up to this time has prevented wider participation in early phase clinical trials will be investigated. Based on our assessments to date, community-based oncologists perceive that patient barriers to increased participation include age, co-morbidities, poor understanding of the clinical trials process, and the fear and expense of leaving the community to travel to the academic center. Procedures will be developed to measure attitudes and changes in attitudes, develop the needed infrastructure to provide closer links between the academic center and community-site, the necessary on-site resources to conduct safely and completely these trials, and to develop outreach programs within the community sites to increase the awareness, understanding and availability of early phase clinical trials.