RTI Health Solutions, USA.
RTI Health Solutions, USA.
Contemp Clin Trials. 2022 Sep;120:106860. doi: 10.1016/j.cct.2022.106860. Epub 2022 Jul 25.
The Food and Drug Administration (FDA) encourages the assessment of patient-reported outcomes (PROs) in oncology clinical trials. A 2015 review showed that approximately 26% of industry-sponsored oncology trials included assessment of PROs. However, the proportion of recent trials that supported new oncology drug approvals and assessed PROs is unknown. This review found that assessment of PROs was included in about 75% of registration trials that supported 55 new FDA drug approvals during 2014-2018. Patient-reported outcome assessment was included more in randomized controlled trials than in open-label trials (88% vs. 69%, respectively) and more in phase 3 than in phase 2 trials (89% vs. 66%, respectively).
美国食品和药物管理局（FDA）鼓励在肿瘤学临床试验中评估患者报告的结局（PROs）。2015 年的一项审查显示，大约 26%的行业赞助的肿瘤学试验包括对 PROs 的评估。然而，最近支持新的肿瘤药物批准并评估 PROs 的试验的比例尚不清楚。本综述发现，在 2014-2018 年期间，支持 55 项新的 FDA 药物批准的注册试验中，大约有 75%的试验包括了 PROs 的评估。与开放标签试验（分别为 88%和 69%）相比，随机对照试验中更常进行患者报告结局评估，与 2 期试验（分别为 89%和 66%）相比，3 期试验中更常进行。
