First lessons learnt about the regulatory aspects of human research related to COVID-19: Perspectives from the SCTO's Regulatory Affairs Platform

Abstract

This article summarises the findings of an internal survey, which was conducted at the end of the first wave of the COVID-19 pandemic by the Swiss Clinical Trial Organisation’s (SCTO’s) Regulatory Affairs Platform (RA Platform). The survey showed that the Clinical Trial Units (CTUs) and Swiss Group for Clinical Cancer Research (SAKK) centres received many requests to support academic human research on COVID-19 during the first wave of the pandemic. Local strategies to prioritise research projects had to be adopted, new practices were implemented, and ways of working from home were successfully developed. The established RA Platform network was considered helpful for sharing information and effective practices. Synergies among research projects were initially missing, and better coordination should be encouraged. At the same time, services provided by and interactions with Swissmedic, swissethics, and the cantonal ethics committees (ECs) were much appreciated. Swissmedic and ECs focused their resources on projects related to COVID-19 and adapted their procedures to allow studies to start quickly. Some practices have been effective and should continue. The pandemic has shown that Switzerland can be considered a competitive place to launch studies in an emergency situation.