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Evaluating prior cancer exclusion policy to increase lung cancer trial accrual

评估先前的癌症排除政策以增加肺癌试验的应计数量

基本信息

批准号：
9108931
负责人：
David Eric Gerber
金额：
$ 8.1万
依托单位：
UT SOUTHWESTERN MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-07-10 至 2017-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9108931
关键词：
Accounting Adult Affect Americans with Disabilities Act Belief Cancer Patient Cancer Survivor Cessation of life Characteristics Clinical Clinical Research Clinical Trials Clinical Trials Design Data Data Set Diagnosis Disease Eastern Cooperative Oncology Group Eligibility Determination Enrollment Epidemiologic Methods Exclusion Exclusion Criteria Exhibits Goals Government Health Industry Institute of Medicine (U.S.)Institution Knowledge Left Link Literature Malignant Neoplasms Malignant neoplasm of lung Medical Surveillance Medicare National Cancer Institute Outcome Patients Pattern Phase III Clinical Trials Policies Policy Research Prevalence Public Health Recording of previous events Rehabilitation therapy Reporting Research Research Personnel Resected Resources Staging Time Toxic effect Translating Work base cancer clinical trial cancer diagnosis cancer type inclusion criteria novel therapeutics older patient oncology population based prognostic response survival outcome wasting

项目摘要

DESCRIPTION (provided by applicant): Despite intensive efforts to increase participation in cancer clinical trials, fewer than two percent of US adults are enrolled in clinical trials. Over 4% of National Cancer Institute-sponsored cooperative group trials fail to complete accrual. Clinical trial eligibility criteria present one of the most significant barriers to study accrual and one ofthe few accrual factors directly controlled by investigators and sponsors. Over time, these criteria have become more numerous and restrictive. Across cancer types, a history of prior cancer is a widespread exclusion criterion in clinical trials. This common practice reflects concerns that a prior cancer diagnosis could interfere with study conduct or outcomes, but there are no data clearly supporting these assumptions. Because this practice hinders accrual, limits generalizability of findings, and discriminates against cancer survivors, we need to understand its basis and implications. In a preliminary analysis, we found that approximately 80% of industry- and government-sponsored lung cancer trials exclude patients with prior cancer. For some trials, we projected that over 18% of lung cancer patients would be excluded for this reason alone, corresponding to more than 200 excluded patients for some large phase 3 trials. The goal of the proposed study is to determine the prevalence and impact of prior cancer among older patients with lung cancer using a large, representative, population-based US dataset. Given the large and growing number of cancer survivors, this research will have important and immediate impact on lung cancer clinical trial design and conduct. For example, if we document equivalent or better survival for those with prior cancer, investigators and sponsors could change or modify this exclusion criterion. In turn, this will increase study accrual and completion rates, resulting in getting better treatments to more patients sooner.

描述（由申请人提供）：尽管为增加癌症临床试验的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试验。超过4%的国家癌症研究所赞助的合作小组试验未能完成累积。临床试验合格性标准是研究累积的最重要障碍之一，也是研究者和申办者直接控制的少数累积因素之一。随着时间的推移，这些标准变得越来越多，越来越严格。在所有癌症类型中，既往癌症史是临床试验中广泛使用的排除标准。这种常见的做法反映了对既往癌症诊断可能干扰研究实施或结果的担忧，但没有数据明确支持这些假设。由于这种做法阻碍了收益，限制了研究结果的普遍性，并歧视癌症幸存者，我们需要了解其基础和含义。在初步分析中，我们发现大约80%的行业和政府赞助的肺癌试验排除了既往癌症患者。对于一些试验，我们预计超过18%的肺癌患者将仅因这一原因而被排除，相当于一些大型III期试验中有200多名患者被排除。这项研究的目的是使用一个大型的、代表性的、基于人群的美国数据集来确定老年肺癌患者中既往癌症的患病率和影响。鉴于癌症幸存者的数量庞大且不断增长，这项研究将对肺癌临床试验的设计和实施产生重要而直接的影响。例如，如果我们记录了先前患有癌症的患者的等同或更好的生存率，研究者和申办者可以改变或修改此排除标准。反过来，这将增加学习应计费用和完成率，从而更快地为更多患者提供更好的治疗。