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首页> 外文期刊>Journal of Clinical Oncology >End points and trial design in geriatric oncology research: a joint European organisation for research and treatment of cancer-alliance for clinical trials in oncology-international society of geriatric oncology position article.
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End points and trial design in geriatric oncology research: a joint European organisation for research and treatment of cancer-alliance for clinical trials in oncology-international society of geriatric oncology position article.

机译：老年肿瘤学研究的终点和试验设计：一家联合研究与治疗癌症的欧洲组织-肿瘤学临床试验联盟-老年肿瘤学国际学会职位文章。

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摘要

Selecting the most appropriate end points for clinical trials is important to assess the value of new treatment strategies. Well-established end points for clinical research exist in oncology but may not be as relevant to the older cancer population because of competing risks of death and potentially increased impact of therapy on global functioning and quality of life. This article discusses specific clinical end points and their advantages and disadvantages for older individuals. Randomized or single-arm phase II trials can provide insight into the range of efficacy and toxicity in older populations but ideally need to be confirmed in phase III trials, which are unfortunately often hindered by the severe heterogeneity of the older cancer population, difficulties with selection bias depending on inclusion criteria, physician perception, and barriers in willingness to participate. All clinical trials in oncology should be without an upper age limit to allow entry of eligible older adults. In settings where so-called standard therapy is not feasible, specific trials for older patients with cancer might be required, integrating meaningful measures of outcome. Not all questions can be answered in randomized clinical trials, and large observational cohort studies or registries within the community setting should be established (preferably in parallel to randomized trials) so that treatment patterns across different settings can be compared with impact on outcome. Obligatory integration of a comparable form of geriatric assessment is recommended in future studies, and regulatory organizations such as the European Medicines Agency and US Food and Drug Administration should require adequate collection of data on efficacy and toxicity of new drugs in fit and frail elderly subpopulations.
机译：为临床试验选择最合适的终点对于评估新治疗策略的价值很重要。肿瘤学中已经建立了完善的临床研究终点，但由于死亡的竞争风险以及治疗对全球功能和生活质量的潜在影响增加，与老年癌症人群的关系可能并不那么重要。本文讨论了特定的临床终点及其对老年人的利弊。随机或单臂II期试验可以洞悉老年人群的疗效和毒性范围，但理想情况下需要在III期试验中进行确认，不幸的是，III期试验通常会因老年人群的严重异质性，选择困难而受到阻碍偏倚取决于入选标准，医生的看法以及参与意愿的障碍。所有肿瘤学的临床试验均应没有年龄上限，以允许合格的老年人进入。在所谓的标准疗法不可行的环境中，可能需要针对老年癌症患者的具体试验，并结合有意义的结果指标。并非所有的问题都可以在随机临床试验中得到回答，应该在社区环境中建立大型观察性队列研究或注册机构（最好与随机试验平行进行），以便可以比较不同环境中的治疗方式与对预后的影响。在未来的研究中，建议强制性整合类似形式的老年医学评估，而诸如欧洲药品管理局和美国食品药物管理局等监管组织应要求适当收集有关适合和体弱的老年人亚群的新药功效和毒性的数据。

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