DIA Asia 2021-The Evolution Of Clinical Trials And Regulatory Science In A Post-Pandemic Digital World In Asia

The COVID-19 pandemic has caused major disruptions to execution of clinical trials worldwide, impacting all stakeholders across the clinical research industry. The regulatory agencies, ethics committee, researchers and investigative sites have demonstrated flexibility and ingenuity in adopting new approaches in managing and mitigating the challenges presented by COVID-19. These new approaches include (i) organisational preparedness; (ii) virtual trial conduct or decentralised trials which utilise the remote technologies (econsent, recruitment, drug distribution, teleconsult, remote data collection); (iii) remote oversight (monitoring, audit) of clinical trials; (iv) innovative protocol redesign. The considerations in embarking these approaches will be reviewed, from sponsors, CROs, regulators and sites perspectives. As the COVID-19 pandemic subsides, the benefits to remote management will continue to grow its adoption into post-COVID clinical trial designs and conducts, eventually becoming the industry new normal.