Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015
Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015
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DOI：
10.1200/jco.2017.73.4186
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发表时间：
2017-11-20
影响因子：
45.3
通讯作者：
Sridhara, Rajeshwari
中科院分区：
文献类型：
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作者：
Jin, Susan;Pazdur, Richard;Sridhara, Rajeshwari
临床试验资格标准对于确定研究中的患者群体和提高试验安全性是必要的。然而，人们担心癌症临床试验的资格标准过于严格，限制了患者参加临床试验。最近，有倡议重新审查和现代化的肿瘤临床试验资格标准。为了评估当前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办公室的商业研究性新药临床试验申请的资格标准进行了全面审查。我们的研究结果表明，当前癌症临床试验的资格标准倾向于狭窄地定义研究人群，并将研究限制在低风险患者中，这可能无法反映研究之外的更大患者群体。我们讨论了扩大资格标准以纳入更多临床试验患者的潜在领域，以及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的患者群体，提高临床试验的参与度，并增加患者获得新的研究治疗的机会。(C) 2017年由美国临床肿瘤学会出版
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. (C) 2017 by American Society of Clinical Oncology