Clinical trial eligibility criteria are necessary to define the patient population under study and improve trial safety. However, there are concerns that eligibility criteria for cancer clinical trials are too restrictive and limit patient enrollment in clinical trials. Recently, there have been initiatives to re-examine and modernize eligibility criteria for oncology clinical trials. To assess current eligibility requirements for cancer clinical trials, we have conducted a comprehensive review of eligibility criteria for commercial investigational new drug clinical trial applications submitted to the US Food and Drug Administration Office of Hematology and Oncology Products in 2015. Our findings suggest that eligibility criteria for current cancer clinical trials tend to narrowly define the study population and limit the study to lower-risk patients, which may not be reflective of the greater patient population outside of the study. We discuss potential areas for expanding eligibility criteria to include more patients in clinical trials and design options for clinical trials incorporating expanded eligibility criteria. The broadening of clinical trial eligibility criteria can be considered to better reflect the real-world patient population, improve clinical trial participation, and increase patient access to new investigational treatments.

临床试验资格标准对于定义研究对象和提高试验安全性是必要的。然而，令人担忧的是，癌症临床试验的资格标准过于严格，限制了患者在临床试验中的入组。近来，已经有倡议重新检查和现代化肿瘤临床试验的资格标准。为了评估当前对癌症临床试验的资格要求，我们对2015年提交给美国食品和药物管理局血液和肿瘤产品管理局的商业性研究性新药临床试验申请的资格标准进行了全面审查。我们的发现表明，当前癌症临床试验的入选标准倾向于狭义地界定研究人群，并将研究限于低风险患者，这可能无法反映出研究范围之外的更多患者人群。我们讨论了扩大资格标准以将更多患者纳入临床试验的潜在领域，并讨论了纳入扩大资格标准的临床试验的设计选择。可以考虑扩大临床试验资格标准，以更好地反映现实世界中的患者人数，改善临床试验参与度并增加患者获得新研究治疗的机会。我们讨论了扩大资格标准以将更多患者纳入临床试验的潜在领域，并讨论了纳入扩大资格标准的临床试验的设计选择。可以考虑扩大临床试验资格标准，以更好地反映现实世界中的患者人数，改善临床试验参与度并增加患者获得新研究治疗的机会。我们讨论了扩大资格标准以将更多患者纳入临床试验的潜在领域，并讨论了纳入扩大资格标准的临床试验的设计选择。可以考虑扩大临床试验资格标准，以更好地反映现实世界中的患者人数，改善临床试验参与度并增加患者获得新研究治疗的机会。