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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：老年肿瘤学研究中的终点与试验设计研究：欧洲肿瘤联盟研究和治疗肿瘤癌症癌症联盟的联合组织 - 国际老年肿瘤学定位文章。

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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：选择最合适的临床试验终点对于评估新治疗策略的价值非常重要。临床研究的良好终点存在肿瘤学中存在，但由于竞争死亡风险和治疗对全球运作和生活质量的潜在影响，可能与年龄较旧的癌症群体相关。本文讨论了老年人的特定临床终点及其优缺点。随机或单臂第二期试验可以深入了解老年人群的疗效和毒性范围，但理想地需要在III期试验中确认，这不幸的是经常受到较老癌症种群的严重异质性，选择困难的阻碍偏见取决于纳入标准，医师感知和参与意愿的障碍。肿瘤学中的所有临床试验都应该没有上龄限制，以便进入符合条件的老年人。在所谓的标准治疗对于不可行的环境中，可能需要对癌症患者的特异性试验，整合有意义的结果措施。并非所有问题都可以在随机的临床试验中回答，并且应建立大型观察队列研究或社区环境中的注册（最好与随机试验平行），以便在不同环境中进行治疗模式与结果的影响。在未来的研究中建议使用比较形式的GeriTric评估形式的强制性整合，欧洲药物局和美国食品和药物管理局等监管组织应要求充分收集适合和脆弱性老年人的新药的疗效和毒性。

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