Managing oncology clinical trials during COVID-19 pandemic

Roberto J Arai; Camila M V Moniz; André T C Chen; Milena P Mak; Roger Chammas; Paulo M Hoff

doi:10.1016/j.conctc.2020.100637

Managing oncology clinical trials during COVID-19 pandemic

Contemp Clin Trials Commun. 2020 Sep:19:100637. doi: 10.1016/j.conctc.2020.100637. Epub 2020 Aug 13.

Authors

Roberto J Arai¹, Camila M V Moniz^{1

2}, André T C Chen¹, Milena P Mak^{1

2}, Roger Chammas¹, Paulo M Hoff^{1

2}

Affiliations

¹ Instituto do Câncer do Estado de São Paulo - ICESP, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brazil.
² Instituto D'Or de Pesquisa e Ensino - IDOR, São Paulo, Brazil.

Abstract

São Paulo city is the epicenter of the Brazilian COVID-19 pandemic. The Instituto do Cancer do Estado de São Paulo is currently conducting 161 multinational sponsored trials plus 116 in house studies in the oncologic population. There are 242 currently active participants and 180 patients in follow-up. The management of the tightly controlled environment of clinical research becomes a challenge, and the Food and Drug Administration set of priority recommendations for patient safety while maintaining study integrity. Fast adaptations are necessary, and actions coalesce to participant protection from COVID-19. We pointed out critical processes for adjustments, and we believe that our experience may help other academic health centers.

Keywords: COVID-19; Oncology clinical trials.