Transforming Clinical Trial Eligibility Criteria to Reflect Practical Clinical Application.
Transforming Clinical Trial Eligibility Criteria to Reflect Practical Clinical Application.
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DOI：
10.14694/edbk_155880
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发表时间：
2016-01-01
期刊：
影响因子：
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通讯作者：
Ersek, Jennifer L
中科院分区：
文献类型：
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作者：
Kim, Edward S;Atlas, Jennifer;Ersek, Jennifer L
从历史上看，肿瘤学临床试验的重点是比较新药的疗效与护理标准。然而，随着我们对肿瘤学分子途径的理解不断发展，我们预测患者对特定药物如何反应的能力也不断增强，因此与标准疗法的比较变得不再那么重要。生物标志物和相应的诊断测试对于药物开发变得越来越重要，但也限制了可能从治疗中受益的患者类型。人们已经开发出更新的临床试验设计来评估生物标志物丰富的人群中具有临床意义的终点，并且现代分子驱动的临床试验的数量正在稳步增加。与此同时，临床试验入组的障碍也越来越大。许多障碍导致临床试验无法入组，包括患者、医生、机构、方案和监管障碍。在方案层面，资格标准已成为临床试验应计的一大障碍。随着时间的推移，资格标准变得越来越严格。为了吸引足够数量的患者参加分子驱动试验，我们应该仔细考虑资格标准并尝试减少限制性标准。减少限制性资格标准将使更多患者有资格参与临床试验，可能会提高药物批准的速度，并使临床试验结果更准确地反映临床环境中人群的治疗情况。
Historically, oncology clinical trials have focused on comparing a new drug's efficacy to the standard of care. However, as our understanding of molecular pathways in oncology has evolved, so has our ability to predict how patients will respond to a particular drug, and thus comparison with a standard therapy has become less important. Biomarkers and corresponding diagnostic testing are becoming more and more important to drug development but also limit the type of patient who may benefit from the therapy. Newer clinical trial designs have been developed to assess clinically meaningful endpoints in biomarker-enriched populations, and the number of modern, molecularly driven clinical trials are steadily increasing. At the same time, barriers to clinical trial enrollment have also grown. Many barriers contribute to nonenrollment in clinical trials, including patient, physician, institution, protocol, and regulatory barriers. At the protocol level, eligibility criteria have become a large roadblock to clinical trial accrual. Over time, eligibility criteria have become more and more restrictive. To accrue an adequate number of patients to molecularly driven trials, we should consider eligibility criteria carefully and attempt to reduce restrictive criteria. Reducing restrictive eligibility criteria will allow more patients to be eligible for clinical trial participation, will likely increase the speed of drug approvals, and will result in clinical trial results that more accurately reflect treatment of the population in the clinical setting.