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血液恶性肿瘤试验中的老年人:代表性、参与障碍及解决代表性不足的策略。

Older adults in hematologic malignancy trials: Representation, barriers to participation and strategies for addressing underrepresentation.

机构信息

Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.

出版信息

Blood Rev. 2020 Sep;43:100670. doi: 10.1016/j.blre.2020.100670. Epub 2020 Feb 7.

Abstract

Despite a high incidence of hematologic malignancies in older adults, available data indicate that there is disproportionately low representation of adults ≥65 years with hematologic malignancies (greater in patients ≥75 years) in clinical trials. Biological and clinical differences between older and younger adults and diversity within older patients necessitate adequate representation of the older subpopulation in hematologic malignancy trials. This would allow trial results to be generalizable and inform treatment decisions in the older patient population. Restrictive eligibility criteria may be barriers to adequate representation, as older adults do not typically meet these criteria. Efforts to broaden eligibility criteria in clinical trials have been proposed and may promote enrollment of a representative older population with hematologic malignancies. Collaboration among a diverse group of stakeholders will be needed to implement current proposals and evaluate their impact on increasing representation of older adults in trials evaluating therapies for hematologic malignancies.

摘要

尽管老年人中血液系统恶性肿瘤的发病率很高,但现有数据表明,在临床试验中,年龄≥65 岁的血液系统恶性肿瘤患者(≥75 岁的患者比例更高)的代表性严重不足。老年人和年轻人之间存在生物学和临床差异,而且老年患者内部也存在多样性,这就需要在血液系统恶性肿瘤试验中充分代表老年亚群。这将使试验结果具有普遍性,并为老年患者人群的治疗决策提供信息。限制性的入选标准可能是充分代表的障碍,因为老年人通常不符合这些标准。已经提出了放宽临床试验入选标准的努力,这可能会促进有代表性的老年血液系统恶性肿瘤患者入组。需要不同利益相关者之间的合作,以实施当前的提案,并评估其对增加血液系统恶性肿瘤治疗试验中老年人代表性的影响。

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