Cancer Discov. 2020 May;10(5):OF1. doi: 10.1158/2159-8290.CD-NB2020-020. Epub 2020 Mar 31.
In a draft guidance, the FDA urges researchers to take steps to increase enrollment of adults age 65 and older in clinical trials of investigational of cancer drugs. Noting that a drug's risk-benefit profile can vary significantly across age groups, the FDA recommends including older adults in early-phase studies and modifying trial designs and recruitment strategies to make it easier for them to participate.
在一份指导草案中,美国食品药品监督管理局(FDA)敦促研究人员采取措施,增加65岁及以上成年人参与癌症 investigational 药物临床试验的人数。FDA指出,药物的风险效益概况在不同年龄组之间可能有显著差异,建议在早期研究中纳入老年人,并修改试验设计和招募策略,以使他们更易于参与。