Call to action: overcoming enrollment disparities in cancer clinical trials with modernized eligibility criteria.
Call to action: overcoming enrollment disparities in cancer clinical trials with modernized eligibility criteria.
复制标题
DOI：
10.1093/jncics/pkad009
复制
发表时间：
2023-03-01
影响因子：
4.4
通讯作者：
中科院分区：
文献类型：
--
作者：
传统的临床试验资格标准限制了研究人群，延续了登记差异。我们旨在评估现代化资格标准指南在胰腺癌(PC)临床试验中的实施情况。自2014年1月1日以来在美国进行的干预性PC试验，通过Clinicaltrials.gov于2017年12月31日确定为指导前和指导后时代的过渡。对试验的依从性进行评估，并使用Fisher精确检验进行比较。总共确定了198项试验：86项(43.4%)为指导前，112项(56.6%)为指导后。在允许有艾滋病毒病史(8.6%对43.8%；P <； .0001)、既往癌症病史(57.0%对72.3%；P = .034)或同时患有和/或稳定癌症(2.1%对31.1%；P <； .0001)的患者参加试验方面出现了改善。大多数(>；95%)试验符合实验室参考范围，校正了心率(QTC)的QT间期，并合理排除了指导前和指导后的先前治疗。然而，对现代化标准的总体遵守情况仍然很差。我们主张利益攸关方更新协议并仔细审查传统上限制性的资格标准。
Traditional clinical trial eligibility criteria restrict study populations, perpetuating enrollment disparities. We aimed to assess implementation of modernized eligibility criteria guidelines among pancreatic cancer (PC) clinical trials. Interventional PC trials in the United States since January 1, 2014, were identified via clinicaltrials.gov with December 31, 2017, as the transition for pre- and postguidance eras. Trials were assessed for guideline compliance and compared using Fisher exact test. In total, 198 trials were identified: 86 (43.4%) were pre- and 112 (56.6%) postguidance era. Improvements were seen in allowing patients with history of HIV (8.6% vs 43.8%; P < .0001), prior cancer (57.0% vs 72.3%; P = .034), or concurrent and/or stable cancer (2.1% vs 31.1%; P < .0001) to participate. Most (>95%) trials were compliant with laboratory reference ranges, QT interval corrected for heart rate (QTc) cutoffs, and rationalizing excluding prior therapies both pre- and postguidance eras. However, overall compliance with modernized criteria remains poor. We advocate for stakeholders to update protocols and scrutinize traditionally restrictive eligibility criteria.
登录
查看更多内容
影响因子：
45.3
作者：
Oyer, Randall A.;Hurley, Patricia;Pierce, Lori J.
通讯作者：
Pierce, Lori J.
DOI：
10.1158/1078-0432.ccr-20-3853
发表时间：
2021-05-01
期刊：
Clinical cancer research : an official journal of the American Association for Cancer Research
影响因子：
--
作者：
Spira AI;Stewart MD;Jones S;Chang E;Fielding A;Richie N;Wood LS;Thompson MA;Jones L;Nair A;Mahal BA;Gerber DE
通讯作者：
Gerber DE
DOI：
10.1200/jco.21.02492
发表时间：
2022-07-10
期刊：
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子：
--
作者：
通讯作者：
--
影响因子：
45.3
作者：
Lin, Nancy U.;Prowell, Tatiana;Kim, Edward S.
通讯作者：
Kim, Edward S.
DOI：
10.1158/1078-0432.ccr-20-3868
发表时间：
2021-05-01
期刊：
Clinical cancer research : an official journal of the American Association for Cancer Research
影响因子：
--
作者：
Magnuson A;Bruinooge SS;Singh H;Wilner KD;Jalal S;Lichtman SM;Kluetz PG;Lyman GH;Klepin HD;Fleury ME;Hirsch B;Melemed A;Arnaldez FI;Basu Roy U;Schenkel C;Sherwood S;Garrett-Mayer E
通讯作者：
Garrett-Mayer E