ENGOT Recommendations on conduct clinical trials during the COVID-19 pandemic

ENGOT (European Network of Gynaecological Oncological Trial Groups) is a network of national and regional clinical trial units that coordinates and promotes clinical trials within Europe for women with gynaecological cancer. This coordination is relevant for academic clinical trials following the ENGOT model A or B, and for clinical trials sponsored by Industry following ENGOT model C. 

Coronavirus  disease 2019 (COVID-19) pandemic caused by SARS-CoV-2 is severely affecting the health system of many European countries at different levels and with different intensity. In this context, the conduct of clinical trials will be affected due to the impact on function of the health care systems which may become overwhelmed by patients affected by COVID-19, and the free circulation of patients and relatives due to the local government’s extraordinary laws oriented to the isolation of the population at home ...

At the moment of writing this document, FDA, EMA and almost all the European Regulatory Authorities have launched their own recommendations on how to manage clinical trials during the COVID-19 crisis. In particular the EMA guidance covers concrete changes and protocol deviations for dealing with extraordinary situations, such as the need for isolating participants, limited access to public spaces and the reallocation of healthcare professionals. In addition, many ENGOT groups and trial units managing ENGOT trials have initiated their own strategy in order to manage the upcoming challenges. Finally, most of the companies sponsoring ENGOT trials model C have also released their recommendations.

ENGOT Recommendations on conduct clinical trials during COVID-19 Pandemic
Version 1.1, March 23th 2020