Evaluating prior cancer exclusion policy to increase lung cancer trial accrual

 描述(由申请人提供)：尽管加大了参与癌症临床试验的力度，但只有不到2%的美国成年人参加了临床试验。超过4%的由国家癌症研究所赞助的合作小组试验未能完成应计。临床试验资格标准是研究收益的最大障碍之一，也是研究人员和赞助商直接控制的少数几个收益因素之一。随着时间的推移，这些标准变得更加繁多和限制性。在癌症类型中，既往癌症病史是临床试验中广泛排除的标准。这种常见的做法反映了人们的担忧，即先前的癌症诊断可能会干扰研究的进行或结果，但没有数据明确支持这些假设。因为这种做法阻碍了应计，限制了研究结果的概括性，并歧视癌症幸存者，我们需要了解它的基础和影响。在初步分析中，我们发现，大约80%的行业和政府资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%的肺癌患者仅因此原因就会被排除在外，相当于在一些大型3期试验中有200多名患者被排除在外。这项拟议研究的目标是利用一个大型的、具有代表性的、以人群为基础的美国数据集，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越来越多，这项研究将对肺癌临床试验的设计和进行产生重要和直接的影响。例如，如果我们记录了既往癌症患者的同等或更好的存活率，研究人员和赞助商可以改变或修改这一排除标准。反过来，这将增加学习收益。 和完成率，从而更快地为更多的患者提供更好的治疗。

 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.