Barriers to accrual in cancer clinical trials

描述(由申请人提供) 每年只有2%-4%的新诊断的成年癌症患者参与临床试验，包括早期研究。此外，少数族裔和老年人在临床试验中的代表性一直很低。低应收率有负面影响，延长试验持续时间，延迟结果分析，或导致研究提前结束。必须确定和克服患者登记的障碍，以增加收益。加州大学戴维斯分校的研究人员和其他人的工作发现了几个障碍，包括误解、错误信息、种族同质人口、地理和数据管理问题、报销问题以及医生偏见，这可能会转化为与患者互动不足。这项提案将通过深入调查癌症护理获取的各个层面的障碍来探索和解决围绕早期试验收益的问题：从宏观层面、基于人群的信息收集和传播战略到中观层面克服资格/临床试验设计障碍的努力，再到微观层面基于互动的障碍。这项为期两年的计划的总体假设是，通过开发和测试克服这些障碍的干预措施，患者在早期试验中的收益将得到提高，并将通过以下三个目标得到解决：1)提高患者、公众和医生对早期临床试验和随之而来的报销问题的认识；2)开发新的I期试验设计，增强患者获得新型研究抗癌药物的机会；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。由首席调查员小普里莫·N·劳拉博士领导的多学科团队(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、营销和广告等)的专业知识加强了这一建议。为了监督这项为期两年的研究计划的实施，将组织一个障碍指导委员会(BSC)，该委员会由癌症控制和卫生服务研究领域的知名领导者组成。服务不足的、少数群体、老年人和妇女群体，以及在可能的情况下，儿童将在适当的情况下特别针对儿童，以增加他们对早期试验的参与。

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.