Revisiting Prior Cancer as an Exclusion Criterion for Cancer Clinical Trials

项目说明(摘要) 尽管密集地努力提高参与度，但只有不到2%的美国成年人注册了临床 审判。超过40%的由国家癌症研究所(NCI)赞助的试验未能完成应计。临床试验 资格标准是研究权责发生制最重要的障碍之一，也是为数不多的权责发生制之一 由调查人员和发起人直接控制的因素。既往癌症是一项广泛的排除标准 癌症试验。我们的研究将提供客观地重新考虑排除癌症所需的新证据 癌症临床试验中新诊断(意外)癌症的幸存者。具体来说，在两个目标中，我们将 1)系统地审查该标准是如何被纳入NCI发起的试验方案的，以及2)评估 既往癌症对患有六种常见和致命疾病的老年患者特定原因和全原因死亡率的影响 癌症：乳腺癌、结直肠癌、肾癌、肝癌、非霍奇金淋巴瘤和胰腺癌。我们将进行这些工作 使用复杂的流行病学和统计方法进行分析，适用于以人群为基础的高质量 先知-联邦医疗保险数据。我们将通过我们的外部咨询委员会迅速发布调查结果，该委员会由以下成员组成 临床试验和患者权益倡导者的国家领导者。这项工作对改变研究的潜在影响 而实践是巨大的。在美国所有被诊断为癌症的人中，超过三分之一的人被诊断出 这项提案中的六种癌症类型中的一种；在这些癌症中，估计有13.5%的人超过65岁 有癌症病史，因此有系统地被排除在癌症试验之外的风险。

Project Description (abstract) Despite intensive efforts to increase participation, fewer than two percent of US adults are enrolled in clinical trials. More than 40% of National Cancer Institute (NCI)-sponsored trials fail to complete accrual. Clinical trial eligibility criteria present one of the most significant barriers to study accrual and one of the few accrual factors directly controlled by investigators and sponsors. Prior cancer is a widespread exclusion criterion in cancer trials. Our study will provide novel evidence required to objectively reconsider the exclusion of cancer survivors with newly diagnosed (incident) cancer from cancer clinical trials. Specifically, in two aims, we will 1) systematically review how this criterion is incorporated in NCI-sponsored trial protocols and 2) evaluate the impact of prior cancer on cause-specific and all-cause mortality for older patients with six common and deadly cancers: breast, colorectal, kidney, liver, Non-Hodgkin’s lymphoma, and pancreas. We will conduct these analyses using sophisticated epidemiologic and statistical methods applied to high-quality, population-based SEER-Medicare data. We will quickly disseminate findings via our External Advisory Board comprised of national leaders in clinical trials and patient advocates. The potential impact of this work to change research and practice is enormous. More than one third of all people diagnosed with cancer in the US are diagnosed with one of the six cancer types in this proposal; and of these, an estimated 13.5% of those over age 65 years have a prior cancer history and thus are at risk of systematic exclusion from cancer trials.