Managing oncology clinical trials during COVID - 19 pandemic

Abstract

São Paulo city is the epi cen ter of the Brazil ian COVID - 19 pan demic. The In sti tuto do Can cer do Es tado de São Paulo is cur rently con duct ing 161 multi na tional spon sored tri als plus 116 in house stud ies in the on co logic pop u la tion. There are 242 cur rently ac tive par tic i pants and 180 pa tients in fol low - up. The man age ment of the tightly con trolled en vi ron ment of clin i cal re search be comes a chal lenge, and the Food and Drug Ad min is tra - tion set of pri or ity rec om men da tions for pa tient safety while main tain ing study in tegrity. Fast adap ta tions are nec es sary, and ac tions co a lesce to par tic i pant pro tec tion from COVID - 19. We pointed out crit i cal processes for ad just ments, and we be lieve that our ex pe ri ence may help other aca d e mic health cen ters.