Revisiting Prior Cancer as an Exclusion Criterion for Cancer Clinical Trials

项目描述（摘要） 尽管为增加参与做出了大量努力，但只有不到2%的美国成年人参加了临床研究。 审判超过40%的国家癌症研究所（NCI）赞助的试验未能完成累积。临床试验 资格标准是研究应计的最重要障碍之一，也是少数应计项目之一。 由研究者和申办者直接控制的因素。既往癌症是一个广泛的排除标准， 癌症试验我们的研究将为客观地重新考虑排除癌症提供新的证据 来自癌症临床试验的新诊断（事件）癌症幸存者。具体而言，我们将在两个目标中， 1)系统地审查如何将这一标准纳入NCI申办的试验方案; 2）评价 既往癌症对老年患者病因特异性和全因死亡率的影响， 癌症：乳腺癌、结肠直肠癌、肾癌、肝癌、非霍奇金淋巴瘤和胰腺癌。我们将进行这些 使用先进的流行病学和统计方法进行分析， SEER-Medicare数据。我们将通过我们的外部咨询委员会迅速传播调查结果， 临床试验的国家领导人和患者倡导者。这项工作改变研究的潜在影响 实践是巨大的。在美国，超过三分之一被诊断患有癌症的人 这六种癌症中的一种;其中，估计有13.5%的65岁以上的人 有既往癌症史，因此有被系统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.