Lara Gongora Aline B, Werutsky Gustavo, Jardim Denis L, Nogueira-Rodrigues Angelica, Barrios Carlos H, Mathias Clarissa, Maluf Fernando, Riechelmann Rachel, Fraga Maurício, Gomes Henry, William William N, Yamada Camilla A F, de Castro Gilberto, Rosa Daniela D, de Melo Andreia C, Sala Raul, Bustamante Eva, Bretel Denisse, Arrieta Oscar, Cardona Andrés F, Bastos Diogo A
Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.
Hospital Sírio-Libanês, São Paulo, Brazil.
JCO Glob Oncol. 2021 Apr;7:649-658. doi: 10.1200/GO.20.00663.
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.
新型冠状病毒肺炎(COVID-19)已影响全球癌症治疗。临床试验是肿瘤患者治疗的重要替代方案,尤其是在拉丁美洲,对于一些患者来说,试验可能是他们获得新型治疗甚至有时是标准治疗的唯一机会。
这是一项横断面研究,向拉丁美洲合作肿瘤学组选定的拉丁美洲机构的350个研究项目代表发送了一份关于COVID-19大流行对肿瘤临床试验影响的22个问题的调查问卷。
有90个研究中心参与了调查,其中70个来自巴西。大多数为部分私立或完全私立机构(n = 77;85.6%),且机构内有确诊的COVID-19病例(n = 57;63.3%)。在80%(n = 72)的回复中,至少部分研究的入组被暂停,主要是因为申办方的决定。临床试验的常规流程受到医疗就诊取消、患者就诊人数减少、其他专科可用性降低和/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,包括远程监测和远程中心启动访视、远程医疗就诊、减少研究团队工作日或居家办公、特殊知情同意程序、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,其中一些改变被建议作为未来肿瘤临床试验常规流程的一部分,特别是那些关于远程方法的改变,如远程医疗。
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一致。这些发现可能支持在大流行后时期改进临床试验的流程和管理。