Barriers to accrual in cancer clinical trials

描述（由申请人提供） 每年，只有2-4%的新诊断癌症的成年患者参加临床试验，包括早期研究。此外，少数民族和老年人在临床试验中的代表性很低。低入组率具有负面影响，延长试验持续时间，延迟结果分析或导致研究提前关闭。必须识别并克服患者入组的障碍，以增加应计费用。加州大学戴维斯分校的研究人员和其他人的工作已经确定了几个障碍，包括误解，错误信息，种族同质的人群，地理和数据管理问题，报销问题和医生偏见，这可能会转化为与患者的互动不足。该提案将通过深入调查癌症治疗获得的各个层面的障碍来探索和解决早期试验累积的问题：从宏观层面，基于人群的信息收集和传播策略到克服资格/临床试验设计障碍的中观层面的努力，再到微观层面的基于相互作用的障碍。这个两年计划的总体假设是，通过开发和测试干预措施来克服这些障碍，将提高患者进入早期试验的比例，并将通过以下三个目标来解决：1）提高患者，公众和医生对早期临床试验和伴随的报销问题的认识; 2）开发一种新的I期试验设计，以提高患者对新型研究性抗癌药物的使用; 3）改善患者，家庭，医疗保健提供者和临床试验研究团队之间的沟通。该提案得到了多学科团队（医学肿瘤学、癌症控制、卫生服务研究和传播、生物伦理学、社会学、流行病学、市场营销和广告等）的专业知识的加强，该团队由首席研究员Primo N.小劳拉马里兰州为了监督这项为期2年的研究计划的实施，将组织一个由癌症控制和卫生服务研究领域的知名领导人组成的障碍指导委员会（BSC）。在适当的情况下，将专门针对服务不足、少数民族、老年人和妇女人群以及儿童（如可能），以增加他们在早期试验中的参与。

DESCRIPTION (provided by applicant) Only 2-4% of all adult patients with newly diagnosed cancer participate in clinical trials, including early phase studies, annually. In addition, representation of minorities and the elderly in clinical trials has been low. Low accrual rates have a negative impact, prolonging trial duration, delaying analysis of results, or leading to early study closure. Barriers to patient enrollment must be identified and overcome to increase accrual. Work by UC Davis investigators and others have identified several barriers, including misperceptions, misinformation, an ethnically homogenous population, geographic and data management problems, reimbursement issues, and physician bias, which may translate into deficient interactions with patients. This proposal will explore and address the issues surrounding early phase trial accrual through an intensive investigation of barriers encompassing various layers of cancer care access: from macro-level, population-based information-gathering and dissemination strategies to meso-level efforts in overcoming eligibility/clinical trial design barriers, to micro-level interaction-based barriers. The overall hypothesis of this two-year plan is that patient accrual into early phase trials will be enhanced by developing and testing interventions to overcome these barriers, and will be addressed through the following three objectives: 1) To increase patient, public, and physician awareness of early phase clinical trials and the attendant reimbursement issues; 2) To develop a novel phase I trial design that enhances patient access to novel investigational anti-cancer agents; 3) To improve communications between patients, family, health care providers, and the clinical trials research team. This proposal is strengthened by the expertise of a multi- disciplinary team (medical oncology, cancer control, health services research and communications, bioethics, sociology, epidemiology, marketing, and advertising, among others), led by Principal Investigator Dr. Primo N. Lara, Jr., MD. To oversee the conduct of this 2-year research plan, a Barriers Steering Committee (BSC) comprised of established leaders in cancer control and health services research will be organized. The underserved, minority, elderly, and women populations, and where possible, children will be specifically targeted where appropriate, to increase their participation in early phase trials.