Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420)

Abstract

PURPOSE 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. METHODS 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. RESULTS 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. CONCLUSION 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.

Impact of the COVID-19 Pandemic on Breast Cancer Management in Portugal: A Cross-Sectional Survey-Based Study of Medical Oncologists

“…It is important to compare the “Portuguese reality” during the worst COVID-19 wave with that of other countries under similar circumstances. To this end, results of the current study are in line with those reported in studies in other countries [ 36 , 37 ]. For example, a similar study utilizing a 29-question survey with responses from 165 medical oncologists accessed via the Italian Association of Medical Oncology (AIOM) and Italian Breast Cancer Study Group (GIM) mailing lists, showed reduced use of (neo)adjuvant weekly paclitaxel or a dose-dense schedule for anthracycline-based chemotherapy during the COVID-19 outbreak, and reduced use of first-line weekly paclitaxel for HER2-positive disease or CDK4/6 inhibitors for luminal tumors with less aggressive characteristics in the metastatic setting [ 36 , 37 ].…”

“…For example, a similar study utilizing a 29-question survey with responses from 165 medical oncologists accessed via the Italian Association of Medical Oncology (AIOM) and Italian Breast Cancer Study Group (GIM) mailing lists, showed reduced use of (neo)adjuvant weekly paclitaxel or a dose-dense schedule for anthracycline-based chemotherapy during the COVID-19 outbreak, and reduced use of first-line weekly paclitaxel for HER2-positive disease or CDK4/6 inhibitors for luminal tumors with less aggressive characteristics in the metastatic setting [ 36 , 37 ]. Furthermore, a cross-sectional study (LACOG 0420) surveying investigators and research coordinators ( n = 90) from research centers in Latin America demonstrated that oncology clinical trials have been significantly affected during the pandemic in Latin America [ 37 ].…”

Characterising COVID-19 empirical research production in Latin America and the Caribbean: A scoping review

“…Empirical COVID-19 studies were found in all LAC countries but were mainly concentrated in six countries that accounted for almost three quarters of all the included papers (Brazil, Mexico, Colombia, Peru, Chile and Argentina), while Uruguay, Panama, Trinidad and Tobago, Chile and Costa Rica had the highest rate of publications per population, with Haiti and Venezuela having the lowest. This coincides with other studies finding a similar list of countries at the top and bottom of research production among LAC countries, for instance during the COVID-19 pandemic with oncology clinical trials [19] and before the pandemic with pharmacological RCTs [20] and clinical trials [21]. The latter also found that over 80% of trials were concentrated in three countries (Brazil, Mexico and Argentina), while the present review found a larger participation of other LAC countries as well, showing that the pandemic probably has pushed for a more country widespread research generation.…”

Global cancer research in the era of COVID-19: a bibliometric analysis

“…Existing disparities in equitable access to timely and effective cancer care globally are expected to increase as the gap widens between healthcare systems with and without sufficient resources to mitigate the negative effects of the pandemic on cancer prevention, early diagnosis and treatment -as well as access to COVID-19 vaccines [2]. Furthermore, the pandemic has exposed significant deficits in how cancer care and health systems prepare, respond and mitigate such events [3,4].…”