SP2-3 The impact of the COVID-19 global pandemic on oncology drug development, clinical research and R&D in Japan

Shimizu, Toshio

The challenges due to the impact of the coronavirus disease 2019 (COVID-19) pandemic and the unprecedented public health crisis are severely affecting oncology clinical trials, early to late phase drug development and clinical research. There has been a decrease in the numbers of new trial initiations, site activations, and patient enrollments, as well as negative impacts upon on-site monitoring, protocol compliance/deviations, and safety assurance for patients with cancer participating in oncology clinical trials. Further, clinical trials may be affected by the spread of COVID-19 owing to the implementation of extreme measures, such as local hospital and patient treatment facility closures, travel restrictions, and delays in the shipment of study treatment and trial supplies. This has been reported in many affected countries, including those in Asia. Currently, all pharmaceutical sponsors are supporting the safety and well-being of clinical trial patients, and investigator sites such as communities, hospitals, and government agencies are striving to regain control over public health and taking proactive steps to ensure regulatory compliance and the scientific integrity of clinical trial data. Similar to the situation in the United States and the European Union, vast majority of oncology clinical trial sites in Japan are still partially facing the challenges raised by this unprecedented event. This session will describe the various aspects including experiences, current situation of, and multiple challenges associated with, the impact of COVID-19 on oncology drug development/ clinical research in Japan, in addition to the experiences and perspectives of key oncology early phase drug development centers in Asia.