COVID-19 effect on clinical research: Single-site risk management experience

Abstract

Background: The ongoing coronavirus disease 2019 (COVID-19) pandemic is extensively impacting new and ongoing clinical trials of various medical products irrespective of indication. It has the potential to adverse effect not only in terms of recruitment and immediate patient care but is also likely to affect the data collection and analysis in the months to come. Aim: The aim was to illustrate the effect of COVID-19 on the clinical research in one of the research centers in low limited-resource country as Egypt and the management plan performed to decrease this adverse impact. Methodology: Secondary data were collected anonymously about the measures implemented to deal with the challenges of conducting the nine ongoing and new clinical researches during COVID-19 pandemic at Faculty of Medicine, Ain Shams University Research Institute-Clinical Research Center. Results: Out of the 47 enrolled participants, thirty participants required investigational product (IP) dispensation during the remaining study period; 27 of them had their IP dispensed at site, and six participants who were from far away Governorate were not able to come to the center due to the partial lockdown and had their IP deliver through courier to their home. Safety laboratory assessment had performed at the site or local laboratory at their hometown. Virtual visit alternatives to in-person visits for communication and patient evaluation had been performed. Recruitment of new participants and opening new sites were stopped in many trials. In order to reduce the on-site activities, in particular, on-site monitoring, all monitoring visits were performed virtually. Conclusion: The adverse impact of COVID-19 pandemic on clinical trials could be lessening by active management plan.