Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420).
Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420).
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DOI：
10.1200/go.20.00663
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发表时间：
2021-04
影响因子：
4.5
通讯作者：
Bastos DA
中科院分区：
文献类型：
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作者：
Lara Gongora AB;Werutsky G;Jardim DL;Nogueira-Rodrigues A;Barrios CH;Mathias C;Maluf F;Riechelmann R;Fraga M;Gomes H;William WN;Yamada CAF;de Castro G Jr;Rosa DD;de Melo AC;Sala R;Bustamante E;Bretel D;Arrieta O;Cardona AF;Bastos DA
COVID-19 影响了全世界的癌症护理。临床试验是治疗肿瘤患者的重要替代方案，尤其是在拉丁美洲，试验可能是其中一些患者获得新颖的、有时是标准治疗的唯一机会。这是一项横断面研究，其中向选定拉丁美洲机构的 350 名研究项目代表（拉丁美洲合作肿瘤学小组成员）发送了一份包含 22 个问题的调查，内容涉及 COVID-19 大流行对肿瘤学临床试验的影响。参与调查的研究中心有 90 个，其中 70 个来自巴西。大多数是部分私立或完全私立 (n = 77; 85.6%)，并在该机构确诊了 COVID-19 病例 (n = 57; 63.3%)。至少在 80% (n = 72) 的回复中，某些研究的应计费用被暂停，这主要是由于申办者的决定。临床试验的常规受到就诊取消、患者就诊减少、其他专科可用性减少和/或随访流程改变的影响。 96.7%的中心采用了正式的COVID-19缓解政策，包括远程监控和远程现场启动访问、远程医疗访问、减少研究团队工作日或家庭办公室、特殊同意程序、将口服药物直接运送到患者家中以及增加门诊诊断研究。重要的是，其中一些变化被建议成为未来肿瘤学临床试验常规的一部分，特别是与远程方法（例如远程医疗）相关的试验。据我们所知，这是第一项评估 COVID-19 对拉丁美洲肿瘤临床试验影响的调查。结果与世界其他地区的调查结果一致。这些发现可能支持大流行后时期临床试验流程和管理的改进。
COVID-19 has affected cancer care worldwide. Clinical trials are an important alternative for the treatment of oncologic patients, especially in Latin America, where trials can be the only opportunity for some of them to access novel and, sometimes, standard treatments. This was a cross-sectional study, in which a 22-question survey regarding the impact of the COVID-19 pandemic on oncology clinical trials was sent to 350 representatives of research programs in selected Latin American institutions, members of the Latin American Cooperative Oncology Group. There were 90 research centers participating in the survey, with 70 of them from Brazil. The majority were partly private or fully private (n = 77; 85.6%) and had confirmed COVID-19 cases at the institution (n = 57; 63.3%). Accruals were suspended at least for some studies in 80% (n = 72) of the responses, mostly because of sponsors' decision. Clinical trials' routine was affected by medical visits cancelation, reduction of patients' attendance, reduction of other specialties' availability, and/or alterations on follow-up processes. Formal COVID-19 mitigation policies were adopted in 96.7% of the centers, including remote monitoring and remote site initiation visits, telemedicine visits, reduction of research team workdays or home office, special consent procedures, shipment of oral drugs directly to patients' home, and increase in outpatient diagnostic studies. Importantly, some of these changes were suggested to be part of future oncology clinical trials' routine, particularly the ones regarding remote methods, such as telemedicine. To our knowledge, this was the first survey to evaluate the impact of COVID-19 on Latin American oncology clinical trials. The results are consistent with surveys from other world regions. These findings may endorse improvements in clinical trials' processes and management in the postpandemic period.