Modernizing Eligibility Criteria for Molecularly Driven Trials
Modernizing Eligibility Criteria for Molecularly Driven Trials
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DOI：
10.1200/jco.2015.62.1854
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发表时间：
2015-09-01
影响因子：
45.3
通讯作者：
Schilsky, Richard L.
中科院分区：
文献类型：
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作者：
Kim, Edward S.;Bernstein, David;Schilsky, Richard L.
随着更多分子靶向药物临床试验的开展，资格标准的数量似乎也在增加。必须在临床试验的基本目标的背景下考虑资格标准的重要性和实用性：了解预期用途患者群体中治疗的风险和益处。尽管资格标准对于确定研究人群和安全进行试验是必要的，但过高的要求可能会严重限制可用于研究的人群，而且通常，该人群不能反映处方药物的一般人群。由学术人员、行业代表和患者权益倡导者组成的美国临床肿瘤学会癌症研究委员会对此问题进行了评估。评价结果好坏参半。大多数医生都认为过高的资格标准会降低研究入组率并延长入组持续时间；然而，这一假设很难用所检查的数据来验证。我们建议组织一次公共研讨会，听取监管机构和主要利益相关者的意见，目的是开发一种算法方法来确定个体研究方案的资格标准，这可能有助于指导未来的研究人员和公司在分子驱动治疗时代简化资格标准。 (C) 2015 年美国临床肿瘤学会
As more clinical trials of molecularly targeted agents evolve, the number of eligibility criteria seems to be increasing. The importance and utility of eligibility criteria must be considered in the context of the fundamental goal of a clinical trial: to understand the risks and benefits of a treatment in the intended-use patient population. Although eligibility criteria are necessary to define the population under study and conduct trials safely, excessive requirements may severely restrict the population available for study, and often, this population is not reflective of the general population for which the drug would be prescribed. The American Society of Clinical Oncology Cancer Research Committee, which comprises academic faculty, industry representatives, and patient advocates, evaluated this issue. Evaluation results were mixed. Most physicians agreed that excessive eligibility criterias slow study enrollment rates and prolong the duration of enrollment; however, this hypothesis was difficult to validate with the data examined. We propose the organization of a public workshop, with input from regulatory bodies and key stakeholders, with the goal of developing an algorithmic approach to determining eligibility criteria for individual study protocols, which may help guide future investigators and companies in streamlining eligibility criteria in the era of molecularly driven therapy. (C) 2015 by American Society of Clinical Oncology